ABX464 ( DrugBank: ABX-464 )
3 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 5 |
| 96 | Crohn disease | 1 |
| 97 | Ulcerative colitis | 39 |
46. Malignant rheumatoid arthritis
Clinical trials : 4,325 / Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
Showing 1 to 5 of 5 diseases
| 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 | NCT04049448 (ClinicalTrials.gov) | October 24, 2019 | 6/8/2019 | Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis Study Evaluating the Long-Term Safety and Efficacy of ABX464in Patients With Moderate to Severe Rheu ... | A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX46 ... | Rheumatoid Arthritis | Drug: ABX464 | Abivax S.A. | NULL | Active, not recruiting | 18 Years | 76 Years | All | 40 | Phase 2 | Belgium;Czechia;France;Hungary;Poland |
| 2 | EUCTR2019-001578-27-HU (EUCTR) | 15/10/2019 | 02/09/2019 | Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis. A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rh ... | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Hungary | ||
| 3 | EUCTR2018-004677-27-BE (EUCTR) | 16/09/2019 | 25/03/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX46 ... | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rh ... | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 4 | EUCTR2018-004677-27-HU (EUCTR) | 25/07/2019 | 25/07/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX46 ... | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rh ... | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 5 | NCT03813199 (ClinicalTrials.gov) | July 4, 2019 | 15/1/2019 | Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis | Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfa) Therapy, or Intolerance to Anti-Tnfa Therapy Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX46 ... | Rheumatoid Arthritis | Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate | Abivax S.A. | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | Belgium;Czechia;France;Hungary;Poland |
96. Crohn disease
Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
Showing 1 to 1 of 1 diseases
| 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 | NCT03905109 (ClinicalTrials.gov) | April 15, 2020 | 3/4/2019 | Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease | A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evalu ... | Crohn Disease | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Belgium |
97. Ulcerative colitis
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
Showing 1 to 10 of 39 diseases
| 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 | EUCTR2021-004398-30-SI (EUCTR) | 24/02/2022 | 02/02/2022 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Ge ... | ||
| 2 | EUCTR2021-004398-30-SK (EUCTR) | 14/12/2021 | 27/10/2021 | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Ge ... | ||
| 3 | NCT05177835 (ClinicalTrials.gov) | December 3, 2021 | 15/12/2021 | Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis Long-term Safety and Efficacy Profile of ABX464in Subjects With Moderate to Severe Active Ulcerative ... | A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX46 ... | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Recruiting | 18 Years | N/A | All | 203 | Phase 2 | Belgium;Czechia;Hungary;Poland |
| 4 | EUCTR2021-004398-30-HU (EUCTR) | 01/12/2021 | 08/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Ge ... | ||
| 5 | EUCTR2021-004398-30-IT (EUCTR) | 29/11/2021 | 01/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - Long-term safety and efficacy follow-up of ABX464 in Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX46 ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Ge ... | ||
| 6 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple do ... | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX46425 mg ... | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 7 | EUCTR2019-000733-39-FR (EUCTR) | 14/05/2020 | 20/02/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. A phase 2b, open-label, efficacy and safety study of ABX464as maintenance therapy in patients with m ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic; ... | ||
| 8 | EUCTR2019-000733-39-GB (EUCTR) | 16/04/2020 | 31/01/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. A phase 2b, open-label, efficacy and safety study of ABX464as maintenance therapy in patients with m ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary; ... | ||
| 9 | EUCTR2019-000733-39-DE (EUCTR) | 20/03/2020 | 13/03/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. A phase 2b, open-label, efficacy and safety study of ABX464as maintenance therapy in patients with m ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;C ... | ||
| 10 | EUCTR2019-000733-39-AT (EUCTR) | 13/02/2020 | 14/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. A phase 2b, open-label, efficacy and safety study of ABX464as maintenance therapy in patients with m ... | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;T ... | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United K ... |