M281 ( DrugBank: - )
5 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 11 | Myasthenia gravis | 22 |
| 46 | Malignant rheumatoid arthritis | 2 |
| 49 | Systemic lupus erythematosus | 3 |
| 53 | Sjogren syndrome | 6 |
| 61 | Autoimmune hemolytic anemia | 11 |
11. Myasthenia gravis
Clinical trials : 332 / Drugs : 234 - (DrugBank : 81) / Drug target genes : 45 - Drug target pathways : 127
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2021210027 | 20/01/2022 | 13/08/2021 | A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia Gravis | Nipocalimab (JNJ-80202135, M281) Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks. Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase Placebo Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase. | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 180 | Phase 3 | Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Northern Ireland;Italy;Mexico;Poland;Russian Federation;Sweden;Turkey;United States Of America;Japan |
| 2 | EUCTR2020-005732-29-DK (EUCTR) | 13/01/2022 | 25/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2020-005732-29-PL (EUCTR) | 10/12/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2020-005732-29-DE (EUCTR) | 19/11/2021 | 23/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2020-005732-29-SE (EUCTR) | 03/11/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 6 | EUCTR2020-005732-29-CZ (EUCTR) | 21/10/2021 | 15/07/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 7 | EUCTR2020-005732-29-ES (EUCTR) | 03/09/2021 | 26/08/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 8 | EUCTR2020-005732-29-IT (EUCTR) | 20/08/2021 | 12/10/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis - N/A | Myasthenia gravis (MG);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: [JNJ-80202135] INN or Proposed INN: Nipocalimab Other descriptive name: M281 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 9 | NCT03896295 (ClinicalTrials.gov) | August 6, 2019 | 28/3/2019 | An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: M281 | Momenta Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | N/A | All | 37 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 10 | EUCTR2018-003618-41-BE (EUCTR) | 05/08/2019 | 05/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 11 | EUCTR2018-003618-41-PL (EUCTR) | 05/07/2019 | 13/05/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 12 | EUCTR2018-003618-41-DE (EUCTR) | 01/07/2019 | 29/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2018-003618-41-GB (EUCTR) | 05/06/2019 | 28/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 14 | EUCTR2018-003618-41-IT (EUCTR) | 09/05/2019 | 24/05/2021 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis - --- | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: [M281] | MOMENTA PHARMACEUTICALS, Inc | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 15 | NCT03772587 (ClinicalTrials.gov) | April 10, 2019 | 10/12/2018 | A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: M281;Other: Placebo | Momenta Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 68 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 16 | EUCTR2018-003618-41-ES (EUCTR) | 02/04/2019 | 12/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2018-002247-28-BE (EUCTR) | 18/03/2019 | 05/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 18 | EUCTR2018-002247-28-PL (EUCTR) | 27/02/2019 | 31/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 19 | EUCTR2018-002247-28-GB (EUCTR) | 05/02/2019 | 30/11/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 20 | EUCTR2018-002247-28-IT (EUCTR) | 04/02/2019 | 04/11/2020 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: [M281] INN or Proposed INN: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 21 | EUCTR2018-002247-28-ES (EUCTR) | 14/12/2018 | 18/01/2019 | To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 22 | EUCTR2021-002479-20-NL (EUCTR) | 28/04/2022 | PK, PD, Safety and Activity of Nipocalimab in Children with Generalized Myasthenia Gravis | An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis | Myasthenia gravis (MG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag Invernational N.V. | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom;Italy;Japan |
46. Malignant rheumatoid arthritis
Clinical trials : 4,356 / Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-000510-42-DE (EUCTR) | 05/10/2021 | 16/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Spain;Poland;Germany;United Kingdom | ||
| 2 | EUCTR2021-000510-42-ES (EUCTR) | 17/09/2021 | 09/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. - IRIS | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Poland;Spain;Germany;United Kingdom |
49. Systemic lupus erythematosus
Clinical trials : 993 / Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-005569-14-BG (EUCTR) | 12/11/2021 | 29/09/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 2 | EUCTR2020-005569-14-HU (EUCTR) | 24/08/2021 | 09/07/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 3 | EUCTR2020-005569-14-ES (EUCTR) | 13/08/2021 | 13/08/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan |
53. Sjogren syndrome
Clinical trials : 305 / Drugs : 325 - (DrugBank : 104) / Drug target genes : 58 - Drug target pathways : 188
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-000665-32-NL (EUCTR) | 16/02/2022 | 21/10/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Germany;Netherlands;Italy;Japan | ||
| 2 | EUCTR2021-000665-32-DE (EUCTR) | 12/11/2021 | 27/07/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 3 | EUCTR2021-000665-32-IT (EUCTR) | 10/11/2021 | 08/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nipocalimab Product Code: [M281] INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Japan;Italy | ||
| 4 | EUCTR2021-000665-32-PT (EUCTR) | 09/11/2021 | 16/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Portugal;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 5 | EUCTR2021-000665-32-ES (EUCTR) | 26/10/2021 | 27/08/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS). | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Poland;Spain;Netherlands;Germany;Italy;Japan | ||
| 6 | EUCTR2021-000665-32-PL (EUCTR) | 16/10/2021 | 16/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan |
61. Autoimmune hemolytic anemia
Clinical trials : 146 / Drugs : 131 - (DrugBank : 59) / Drug target genes : 28 - Drug target pathways : 158
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05221619 (ClinicalTrials.gov) | January 31, 2023 | 5/1/2022 | Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006 | Warm Autoimmune Hemolytic Anemia | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Temporarily not available | N/A | N/A | All | NULL | ||
| 2 | EUCTR2019-000720-17-NL (EUCTR) | 31/03/2020 | 16/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany | ||
| 3 | EUCTR2019-000720-17-DE (EUCTR) | 14/01/2020 | 05/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 4 | EUCTR2019-000720-17-GR (EUCTR) | 27/12/2019 | 08/10/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 5 | EUCTR2019-000720-17-HU (EUCTR) | 05/11/2019 | 06/11/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 6 | NCT04119050 (ClinicalTrials.gov) | October 24, 2019 | 18/9/2019 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension | Warm Autoimmune Hemolytic Anemia | Drug: M281;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 111 | Phase 2/Phase 3 | United States;Brazil;Canada;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Spain;Ukraine;United Kingdom |
| 7 | EUCTR2019-000720-17-FR (EUCTR) | 15/10/2019 | 17/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | Netherlands;Germany;United Kingdom;Italy;United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark | ||
| 8 | EUCTR2019-000720-17-PL (EUCTR) | 09/10/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: Not Applicable Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 9 | EUCTR2019-000720-17-ES (EUCTR) | 19/09/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2019-000720-17-IT (EUCTR) | 16/09/2019 | 27/01/2021 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension - --- | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: [M281] INN or Proposed INN: M281 Other descriptive name: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 11 | EUCTR2019-000720-17-CZ (EUCTR) | 10/09/2019 | 10/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain |