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Clinical trials
catalyst calendar across sponsors →Studies where ABVX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
23 interventional · 8 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisNCT05177835Number of adverse events in ABX464 treated subjectsOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: ABX464 | Ulcerative Colitis | 203 | Mar 2028 | ≤ 589 d | 2026-04-27 |
| Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's DiseaseNCT06456593Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: Obefazimod · Other: Placebo | Moderately to Severely Active Crohn Disease | 212 | Dec 2026 | ≤ 133 d | 2026-04-27 |
| Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet FormulationNCT07453784Maximum Plasma Concentration (Cmax)Randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Obefazimod 50 mg Capsule, Obefazimod Minitablet 50 mg | Healthy | 44 | Sep 2026 | ≤ 41 d | 2026-04-06 |
| ABTECT - MaintenanceNCT05535946Rate of subjects in clinical remission at Week 44Randomized · Triple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: ABX464, Placebo | Ulcerative Colitis | 1,116 | 2026-04-28actual | — | 2026-07-07 |
| ABX196 in Combination With Nivolumab in Patients With Hepatocellular CarcinomaNCT03897543Incidence of adverse events (AEs)Open-label · Treatment | Phase 1/2 | Recruiting | Drug: ABX196 | Carcinoma, Hepatocellular | 48 | 2021-06-30 | — | 2021-03-26 |
| ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1NCT05507203Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: ABX464, Placebo | Ulcerative Colitis | 639 | 2025-06-24actual | — | 2025-10-24 |
| ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2NCT05507216Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: ABX464, Placebo | Ulcerative Colitis | 636 | 2025-06-24actual | — | 2025-10-24 |
| Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative ColitisNCT04023396results2025-04-27Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464 | Ulcerative Colitis | 217 | 2023-02-23actual | — | 2026-05-06 |
| Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid ArthritisNCT04049448Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severityOpen-label · Treatment | Phase 2 | Completed | Drug: ABX464 | Rheumatoid Arthritis | 40 | 2023-01-23actual | — | 2025-11-17 |
| Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease PatientsNCT03905109The co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss ofRandomized · Quadruple-masked · Treatment | Phase 2/3 | Withdrawnsponsor's stated reason: Study design revised and to be found under new NCT06456593 ABX464-202 | Drug: ABX464, Placebo | Crohn Disease | 0 | 2022-09-19 | — | 2024-07-31 |
| Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative ColitisNCT03368118results2025-03-05Number of Treatment-emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464 | Ulcerative Colitis | 22 | 2022-07-12actual | — | 2025-05-29 |
| Safety and Pharmacokinetics Study in Healthy Japanese VolunteersNCT05032560Incidence of adverse events (AEs) and SAEsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ABX464, Placebo | Healthy Volunteers | 48 | 2022-02-18actual | — | 2023-01-26 |
| Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464NCT05121714Part A Evaluate the potential for inhibition and/or induction of CYP1A2 in vivo based on the Peak Plasma Concentration (Cmax) of caffeine (a known CYP1A2 substrate) in the presence and absence of ABX464.Non-randomized · Open-label · Prevention | Phase 1 | Completed | Drug: Caffeine, ABX464, Fluvoxamine | Healthy | 59 | 2021-05-18actual | — | 2022-01-05 |
| Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid ArthritisNCT03813199results2022-04-07Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus PlaceboRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464 50mg, Matching Placebo, ABX464 100mg, Methotrexate | Rheumatoid Arthritis | 60 | 2021-04-27actual | — | 2023-02-15 |
| Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative ColitisNCT03760003results2025-11-28Reduction From Baseline in Modified Mayo Score (MMS) at Week 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464 100 mg, ABX464 50 mg, ABX464 25 mg, Placebo | Ulcerative Colitis | 355 | 2021-04-01actual | — | 2025-11-28 |
| ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19NCT04393038results2025-11-26Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period.Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: Interim analysis concludes that the study is futile | Drug: ABX464, Placebo | COVID-19 | 509 | 2021-03-05actual | — | 2025-11-26 |
| A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive AdultsNCT02990325results2023-03-31Area Under the Curve (AUC) of ABX464 in SeraNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ABX464 150mg, ABX464 50mg, ABX464 50mg | HIV Infections, Health Volunteers | 36 | 2018-12-27actual | — | 2023-03-31 |
| ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisNCT03093259results2023-02-08Number of Subjects With Treatment-emergent Adverse EventsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464, Placebo oral capsule | Ulcerative Colitis | 32 | 2018-07-25actual | — | 2024-06-03 |
| ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor TreatmentNCT02735863results2024-09-19Number of Participants With Adverse EventsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ABX464, Placebo | HIV Infection | 30 | 2017-08-30actual | — | 2024-09-19 |
| Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis BNCT02249988Percentage of subjects with viral load < 40 IU/mL at Week 48.Randomized · Open-label · Treatment | Phase 2/3 | Completed | Drug: ABX203 therapeutic Hepatitis B vaccine treatment arm | Chronic Hepatitis B | 261 | Dec 2016actual | — | 2017-01-24 |
| Safety, PK and PD Study of ABX464 in Untreated HIV PatientsNCT02452242Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ABX464 · Other: Placebo | Human Immunodeficiency Virus Infections | 70 | Dec 2015actual | — | 2016-05-30 |
| Food Effect on Pharmacokinetic Parameters of ABX464NCT02731885Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ABX464 Single dose, ABX464 Repeated dose | Healthy Volunteers | 48 | Jun 2015actual | — | 2016-04-08 |
| ABX464 First in Man StudyNCT02792686Percentage of patients experiencing at least one Adverse EventOpen-label · Treatment | Phase 1 | Completed | Drug: ABX464 | Healthy Volunteers | 24 | Jul 2014actual | — | 2024-05-17 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19