Long-term Safety, Tolerability, and Efficacy of Balinatunfib in Adults with Crohn's Disease or Ulcerative Colitis: A Multicenter Extension Study

The primary objective of this study is to assess the long-term safety and tolerability of various doses of balinatunfib in adults diagnosed with Crohn's disease or ulcerative colitis. 4, 5

Secondary objectives include the evaluation of long-term efficacy of different doses of balinatunfib in participants with Crohn's disease and ulcerative colitis. 5

This study involves 240 participants diagnosed with Crohn's disease or ulcerative colitis. The population includes both male and female individuals, with age ranges categorized under codes 3 and 4. Selection is based on the completion of treatment at Week 52 in the SPECIFI-CD or SPECIFI-UC studies. Specific requirements include the completion of double-blinded treatment or open-label treatment with appropriate outcomes at the 52-week mark. Contraception must be utilized in accordance with local regulations. Female participants are excluded if they are pregnant or breastfeeding.

This phase 4 multinational, multicenter extension study is designed to investigate the long-term safety, tolerability, and efficacy of balinatunfib in adults diagnosed with Crohn's disease or ulcerative colitis. The research methodology focuses on assessing treatment-emergent adverse events, serious adverse events, and adverse events of special interest as primary endpoints. Secondary objectives include evaluating the proportion of participants achieving endoscopic remission and clinical remission using metrics such as the Crohn's disease activity index and the modified Mayo Score. The study involves individuals who have completed treatment at Week 52 of the SPECIFI-CD or SPECIFI-UC trials. The total duration of the clinical trial is estimated to span from May 2026 to May 2030.

The experimental medication, balinatunfib, is administered as a film-coated tablet. This substance is delivered via the oral route. The specific dosage for this study is defined as 00 mg.

A placebo is utilized in the study. This comparator treatment consists of a substance that does not contain the same excipients as the test product and is also administered by the oral route.

The efficacy of balinatunfib in adults with Crohn's disease or ulcerative colitis is evaluated through several secondary endpoints. In patients with Crohn's disease, efficacy is assessed based on the proportion of participants achieving endoscopic remission as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Additionally, the proportion of participants reaching clinical remission is determined using the Crohn's Disease Activity Index (CDAI).

For individuals with ulcerative colitis, efficacy assessment focuses on the proportion of participants achieving clinical remission, which is measured using the modified Mayo Score (mMS).