Dapirolizumab pegol ( DrugBank: Dapirolizumab pegol )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 2 |
| 49 | 全身性エリテマトーデス | 34 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2019-001967-58-FR (EUCTR) | 20/11/2020 | 27/05/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy | ||
| 2 | EUCTR2019-001967-58-PL (EUCTR) | 26/10/2020 | 25/06/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Belgium;Poland;Germany;Switzerland;Italy |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 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 | EUCTR2019-003409-83-GR (EUCTR) | 12/09/2022 | 04/07/2022 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 2 | EUCTR2019-003407-35-DE (EUCTR) | 22/08/2022 | 17/02/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan | ||
| 3 | EUCTR2019-003407-35-DK (EUCTR) | 13/07/2022 | 17/06/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan | ||
| 4 | EUCTR2019-003407-35-ES (EUCTR) | 09/03/2022 | 17/01/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Czechia;Taiwan;Hong Kong;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Japan;China | ||
| 5 | EUCTR2019-003406-27-DK (EUCTR) | 09/03/2022 | 04/03/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 6 | EUCTR2019-003409-83-DE (EUCTR) | 17/01/2022 | 26/07/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 7 | EUCTR2019-003409-83-HU (EUCTR) | 15/10/2021 | 01/09/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 8 | EUCTR2019-003409-83-BG (EUCTR) | 21/09/2021 | 29/06/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 9 | NCT04976322 (ClinicalTrials.gov) | July 27, 2021 | 14/7/2021 | A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Dapirolizumab pegol | UCB Biopharma SRL | NULL | Enrolling by invitation | 16 Years | N/A | All | 760 | Phase 3 | Germany;Greece;Hungary;Mexico;Poland;Romania;Serbia;Spain;Taiwan;United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia |
| 10 | EUCTR2019-003409-83-ES (EUCTR) | 15/07/2021 | 14/06/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 11 | EUCTR2019-003406-27-CZ (EUCTR) | 23/03/2021 | 23/12/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 12 | EUCTR2019-003406-27-PT (EUCTR) | 14/12/2020 | 29/06/2020 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 13 | EUCTR2019-003406-27-IT (EUCTR) | 07/10/2020 | 21/01/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - - | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: [CDP7657] INN or Proposed INN: Dapirolizumab pegol | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 14 | EUCTR2019-003406-27-DE (EUCTR) | 17/09/2020 | 15/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 15 | EUCTR2019-003406-27-AT (EUCTR) | 11/09/2020 | 29/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 16 | EUCTR2019-003406-27-GB (EUCTR) | 09/09/2020 | 15/07/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 17 | NCT04294667 (ClinicalTrials.gov) | August 12, 2020 | 27/2/2020 | A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: DZP;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 16 Years | N/A | All | 450 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Romania;Serbia;Spain;Taiwan;United Kingdom |
| 18 | EUCTR2019-003406-27-GR (EUCTR) | 30/07/2020 | 02/06/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 19 | EUCTR2019-003406-27-HU (EUCTR) | 28/07/2020 | 20/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 20 | EUCTR2019-003406-27-BG (EUCTR) | 09/06/2020 | 21/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 21 | EUCTR2019-003406-27-ES (EUCTR) | 02/06/2020 | 28/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 22 | EUCTR2015-004457-40-PL (EUCTR) | 04/11/2016 | 02/09/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 23 | EUCTR2015-004457-40-ES (EUCTR) | 10/10/2016 | 05/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 24 | EUCTR2015-004457-40-HU (EUCTR) | 20/09/2016 | 13/07/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 25 | EUCTR2015-004457-40-DE (EUCTR) | 19/09/2016 | 22/06/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 26 | EUCTR2015-004457-40-BG (EUCTR) | 13/09/2016 | 03/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 27 | NCT02804763 (ClinicalTrials.gov) | June 2, 2016 | 14/6/2016 | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Drug: Dapirolizumab pegol (DZP) | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 182 | Phase 2 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine |
| 28 | EUCTR2019-003406-27-BE (EUCTR) | 28/02/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 29 | EUCTR2019-003406-27-FR (EUCTR) | 22/12/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 30 | EUCTR2019-003409-83-CZ (EUCTR) | 15/03/2022 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 760 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | |||
| 31 | EUCTR2019-003407-35-BE (EUCTR) | 24/01/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | Hong Kong;United States;Czechia;Japan;United Kingdom;Portugal;Spain;Greece;Canada;Austria;Belgium;China;Taiwan;Poland;Denmark;Italy;France;Bulgaria;Serbia;Germany | |||
| 32 | EUCTR2019-003406-27-PL (EUCTR) | 14/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | |||
| 33 | EUCTR2019-003407-35-AT (EUCTR) | 23/03/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;China;Japan | |||
| 34 | EUCTR2019-003409-83-PL (EUCTR) | 27/05/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | NA | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan |