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.
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
The three most relevant inclusion criteria: - Men or women aged at least 16 years with a diagnosis of UC confirmed by colonoscopy and histology prior to the pre-screening date. - Patients must have moderate to severe active disease. Additionally, patients must have demonstrably inadequate responses to at least one of the following treatments (e.g., lack of response, loss of response, or intolerance): corticosteroids, immunosuppressants, biological therapies, S1P receptor modulators and/or JAK inhibitors and/or newly approved medications. - Female patients and partners of male patients who can become pregnant must agree to use either two highly effective methods or one highly effective method in combination with one effective method of contraception during the study and for at least 21 days after the last dose of the study drug. Male participants must use a condom for all sexual relations during the entire treatment period of the study and for 21 days after the last dose of the study drug. (BASEC)
Exclusion criteria
The three most relevant exclusion criteria: - Other gastrointestinal diseases, such as UC, limited to isolated proctitis (when the mucosal tissue of the inner rectum becomes inflamed), primary sclerosing cholangitis (a disease that destroys the bile ducts) or autoimmune hepatitis (a chronic disease in which the immune system attacks healthy, normal liver cells), Crohn's disease (CD) or inflammation of the colon. - History or active cancer (expected if the disease has not been active for at least 5 years). - Pregnant or breastfeeding women or women who can become pregnant and plan to become pregnant during the study duration, as well as male patients with a partner who can become pregnant and plans to become pregnant during the study duration. (BASEC)
Trial sites
Basel, Bern, Zurich
(BASEC)
Sponsor
ABIVAX S.A., Paris, France IQVIA AG, Branch Basel, Basel
(BASEC)
Contact
Contact Person Switzerland
Luc Biedermann
+41 44 255 85 48
luc.biedermann@clutterusz.chUniversitätsspital Zürich, Klinik für Gastroenterologie und Hepatologie, Rämistrasse 100, 8091 Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
13.07.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available