Abivax is currently conducting a global phase 3 clinical program to test the tolerability, safety and efficacy of its product candidate obefazimod in ulcerative colitis.

Phase 2a and 2b clinical trials have successfully been conducted with obefazimod for the treatment of ulcerative colitis (UC). A phase 2a clinical study has also been completed for the treatment of rheumatoid arthritis (RA). The studies consisted each of two parts, an induction phase and a subsequent maintenance phase.

Clinical Phase 3 Program in UC

1,200 UC patients across 36 countries will take part in the pivotal phase 3 program that consists of two induction studies and a single subsequent maintenance study (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) induction trials and ABTECT maintenance trial (ABX464-107)).

These three pivotal studies are all randomized, double-blind, and placebo controlled, using independent, blinded review of the videotaped endoscopies. The primary efficacy endpoint, assessed at week 8 in the induction and at week 44 in the maintenance study, will be clinical remission according to the modified Mayo Score, as required by FDA.

In consultation with international regulators, including both the FDA and EMA, obefazimod 25mg and 50mg will be investigated in the ABTECT program for the treatment of UC in advanced therapies (AT) naïve and in AT-failure patients to support the future submission of marketing authorizations.

600 study sites will be participating in the studies, of which 25% will be located in North America, 42% will be initiated in Europe, 26% in Asia and 7% of the sites will be situated in other geographies.

Phase 3 Induction Studies in Ulcerative Colitis

The inclusion of patients in the induction studies ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) is ongoing.

Further information

You can find more information on the countries and the study centers currently open for recruitment at clinicaltrials.gov.

Phase 3 Maintenance Study in Ulcerative Colitis

Only patients who conclude the induction phase of one of the two induction studies have the possibility to roll over into the ABTECT maintenance trial (ABX464-107), where long-term effects of the treatment are evaluated.

Important Information

Please note that the drug candidate obefazimod is at present in the clinical testing stage and subject to the regulations set by the competent authorities.

Abivax is legally not entitled to decide whether a patient is eligible to be included in the clinical trials that Abivax sponsors. The investigating physicians of the clinical study centers are the sole individuals competent for deciding whether a patient is eligible, according to the inclusion and exclusion criteria defined in the corresponding clinical study protocol.

Additionally, Abivax cannot communicate or interact with individual patients on the conduct or progress of the study. You will find all publicly available information at clinicaltrials.gov.