A study to evaluate the efficacy and safety of Obefazimod (ABX464) in patients with moderate to severe active ulcerative colitis (UC) taking Obefazimod or placebo once daily.

Descrizione riassuntiva dello studio

Obefazimod is a novel, orally administered anti-inflammatory drug candidate that specifically increases the production of a molecule called miR-124, which is produced naturally by the human body and has anti-inflammatory properties. Clinical experiences gained during the development phase of Obefazimod with doses of 25 mg and 50 mg showed relevant efficacy with a favorable short- and long-term safety profile. This study is part of a global Phase III study program consisting of two similar 8-week induction studies (ABX464-105 and ABX464-106), followed by a 44-week maintenance study (ABX464-107). The maintenance study will be offered to all eligible and willing participants from both induction studies. Approximately 1224 patients (612 per induction study) will be enrolled in this program and followed up in 36 countries worldwide. Switzerland will participate in ABX464-105, followed by ABX464-107, and about 10 patients will be enrolled in the study there.

(BASEC)

Intervento studiato

This study will consist of 3 treatment groups, in which 2 doses of Obefazimod and a placebo will be compared (a placebo looks the same as Obefazimod but contains no active ingredient). Participants will be randomly assigned to one of three treatment groups, with a 75% chance of receiving Obefazimod and a 25% chance of receiving the placebo. The study drug will be provided in the form of a capsule (in blister packs) to be taken orally once daily.

This study consists of three phases: a pre-screening phase of up to 28 days to check the eligibility of patients, an 8-week treatment phase, and a 28-day follow-up phase.

Eligible patients will undergo the following examinations as part of the study:

- physical examinations

- electronic diaries and questionnaires (on an electronic device)

- colonoscopies (videos from inside the intestine) with biopsies (small samples from the intestinal wall)

- blood draws

- electrocardiograms

- eye examinations

(BASEC)

Malattie studiate

Ulcerative colitis (UC) is part of the group of inflammatory bowel diseases (IBD), characterized by a misregulated immune response associated with chronic inflammation in the gastrointestinal tract, affecting the rectum and colon. The cause of UC is unknown, but it is believed that genetic, environmental, and immunological factors contribute to its development. UC is typically diagnosed at the end of adolescence/early adulthood. Quality of life is dramatically affected, ranging from direct physical disabilities to financial burdens. Among the global population suffering from UC, 66% report being affected at work and 73% in their leisure activities. More broadly, UC also burdens immediate family members and affects family quality of life. Most patients present with mild to moderate UC at diagnosis, but about one-third progress to moderate to severe UC. Conventional therapies such as 5-aminosalicylic acids (5-ASA), corticosteroids, and immunosuppressants have mostly been used to treat these patients. Since 2005, new advanced therapeutics known as biologics have been approved for the treatment of UC. Biologics are produced using biotechnological methods and block certain parts of the immune system, such as pro-inflammatory proteins (e.g., TNF inhibitors Infliximab, Adalimumab, and Golimumab, integrin antagonists like Vedolizumab, and also IL 23 inhibitors like Ustekinumab) and more recently JAK inhibitors (e.g., Tofacitinib, Filgotinib, Upadacitinib) and S1P modulators (e.g., Ozanimod).

(BASEC)

Sponsor

ABIVAX S.A., Paris, France IQVIA AG, Branch Basel, Basel

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Berna

(BASEC)

Data di approvazione del comitato etico

13.07.2023

(BASEC)

Risultati dello studio