17 completed, 2 active not recruiting, 2 recruiting, 1 terminated. 15 Phase 2, 7 Phase 1, 6 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation Obefazimod 50 mg Capsule, Obefazimod Minitablet 50 mg - Healthy | Phase 1 | Recruiting | Abivax S.A. | 44 | 2026-03-03 | 2026-04-06 |
| Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease Obefazimod, Placebo - Moderately to Severely Active Crohn Disease | Phase 2 | Recruiting | Abivax S.A. | 212 | 2024-10-30 | 2026-04-27 |
| ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 ABX464, Placebo - Ulcerative Colitis | Phase 3 | Completed | Abivax S.A. | 636 | 2023-01-25 | 2026-09-10 |
| ABTECT - Maintenance ABX464, Placebo - Ulcerative Colitis | Phase 3 | Active not recruiting | Abivax S.A. | 1116 | 2023-01-16 | 2026-07-07 |
| ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 ABX464, Placebo - Ulcerative Colitis | Phase 3 | Completed | Abivax S.A. | 639 | 2022-11-16 | 2026-09-10 |
| Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients ABX464, Placebo - Crohn Disease | Phase 2 / Phase 3 | Withdrawn | Abivax S.A. | 2022-09-19 | 2024-07-31 | |
| Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis ABX464 - Ulcerative Colitis | Phase 2 | Active not recruiting | Abivax S.A. | 203 | 2021-12-03 | 2026-04-27 |
| Safety and Pharmacokinetics Study in Healthy Japanese Volunteers ABX464, Placebo - Healthy Volunteers | Phase 1 | Completed | Abivax S.A. | 48 | 2021-09-27 | 2023-01-26 |
| Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464 Caffeine, ABX464, Fluvoxamine - Healthy | Phase 1 | Completed | Abivax S.A. | 59 | 2020-12-17 | 2022-01-05 |
| ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 ABX464, Placebo - COVID-19 | Phase 2 / Phase 3 | Terminated | Abivax S.A. | 509 | 2020-07-01 | 2025-11-26 |
| ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma ABX196 - Carcinoma, Hepatocellular | Phase 1 / Phase 2 | Completed | Abivax S.A. | 10 | 2020-02-18 | 2026-09-29 |
| Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis ABX464 - Ulcerative Colitis | Phase 2 | Completed | Abivax S.A. | 217 | 2020-01-13 | 2026-05-06 |
| Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis ABX464 - Rheumatoid Arthritis | Phase 2 | Completed | Abivax S.A. | 40 | 2019-10-25 | 2025-11-17 |
| Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis ABX464 100 mg, ABX464 50 mg, ABX464 25 mg - Ulcerative Colitis | Phase 2 | Completed | Abivax S.A. | 355 | 2019-08-13 | 2025-11-28 |
| Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis ABX464 50mg, Matching Placebo, ABX464 100mg - Rheumatoid Arthritis | Phase 2 | Completed | Abivax S.A. | 60 | 2019-07-04 | 2023-02-15 |
| Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis ABX464 - Ulcerative Colitis | Phase 2 | Completed | Abivax S.A. | 22 | 2018-01-20 | 2025-05-29 |
| ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis ABX464, Placebo oral capsule - Ulcerative Colitis | Phase 2 | Completed | Abivax S.A. | 32 | 2017-11-16 | 2024-06-03 |
| A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults ABX464 150mg, ABX464 50mg - HIV Infections, Health Volunteers | Phase 1 / Phase 2 | Completed | Abivax S.A. | 36 | 2017-03-27 | 2023-03-31 |
| ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment ABX464, Placebo - HIV Infection | Phase 2 | Completed | Abivax S.A. | 30 | 2016-05-01 | 2024-09-19 |
| Safety, PK and PD Study of ABX464 in Untreated HIV Patients ABX464, Placebo - Human Immunodeficiency Virus Infections | Phase 2 | Completed | Abivax S.A. | 70 | 2015-01-01 | 2016-05-30 |
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Colitis, Ulcerative (8) · Arthritis, Rheumatoid (2) · Crohn Disease (2) · HIV Infections (2) · COVID-19 (1) · Carcinoma, Hepatocellular (1) · Hepatitis B, Chronic (1)
ABX464 (19) · ABX196 (1) · Caffeine (1) · Fluvoxamine (1) · Methotrexate (1)
Belgium (14) · France (13) · Spain (11) · Hungary (10) · Poland (10) · Czechia (9) · Germany (9) · Italy (8) · United Kingdom (8) · Austria (6) · Canada (6) · Slovakia (6) · United States (6) · Serbia (5) · Ukraine (5)
Bruce Sands, MD, PhD (3) · Severine Vermeire, MD, PhD (3) · Bram Verstockt, MD (1) · Laurence Desroys du Roure, PharmD (1) · Paul Gineste (1)
PMID 27799203, PMID 27999038, PMID 28507108, PMID 30800421, PMID 33437904, PMID 34436569, PMID 35641124, PMID 36075249, PMID 39425534, PMID 40417999