Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients with Moderate to Severe Ulcerative Colitis

The primary objective of this study is to evaluate the efficacy of vixarelimab in inducing clinical remission at Week 12 in patients with moderate to severe ulcerative colitis compared to a placebo. Secondary objectives include:

• Evaluation of efficacy regarding clinical response, endoscopic improvement, and endoscopic remission.
• Assessment of safety profiles.
• Characterization of pharmacokinetics.
• Evaluation of the immune response to the study drug.

This clinical trial involves a total of 122 patients diagnosed with ulcerative colitis. The study population includes both male and female participants, including vulnerable individuals, within the specified age range. Eligible subjects must have a confirmed diagnosis of the condition for a minimum of 3 months and present with moderately to severely active disease as measured by the Modified Mayo Score. Selection is further limited to individuals demonstrating an inadequate response, loss of response, or intolerance to conventional or advanced therapies. The primary objective is to evaluate the efficacy of vixarelimab compared to placebo in achieving clinical remission at Week 12.

This is a Phase II, multicenter, induction study with an active treatment extension designed to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab in patients with moderate to severe ulcerative colitis. The study compares the test substance against a placebo to assess the induction of clinical remission at Week 12. The primary endpoint is defined by a modified Mayo Score of ≤ 2 at Week 12. Secondary endpoints include clinical response, endoscopic improvement, endoscopic remission, the incidence and severity of adverse events, serum concentration levels, and the prevalence of anti-drug antibodies. The trial is estimated to occur between April 2024 and July 2027.

Vixarelimab is an investigational medicinal product administered as a solution for injection via a subcutaneous route. In this clinical trial, it is evaluated for the treatment of ulcerative colitis.

A placebo is utilized as a comparator for the experimental treatment.

Background therapies used as auxiliary treatments include azathioprine administered orally, adalimumab administered subcutaneously, methotrexate administered subcutaneously, golimumab administered subcutaneously, and infliximab administered via intravenous use. Additionally, mercaptopurine is administered orally. Other auxiliary medications include corticosteroids administered either orally or intravenously, intestinal antiinfectives via an oral route, and aminosalicilic acid and similar agents for rectal use.

The primary efficacy endpoint is the induction of clinical remission at Week 12. Clinical remission is defined by a modified Mayo Score (mMS) of ≤ 2, which must include a stool frequency subscore of ≤ 1, a rectal bleeding subscore of 0, and an endoscopy subscore of ≤ 1.

Secondary efficacy parameters assessed at Week 12 include:

• Clinical response, characterized by a decrease from baseline in the mMS of ≥ 2 and a reduction of ≥ 30% from baseline, accompanied by either a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding subscore of ≤ 1.
• Endoscopic improvement, defined as a Mayo endoscopy subscore of ≤ 1, where a score of 1 is modified to exclude friability.
• Endoscopic remission, defined as a Mayo endoscopy subscore of 0.
• Serum concentration of vixarelimab at specified timepoints.
• Prevalence of anti-drug antibodies (ADAs) at baseline and the incidence of ADAs during the study.