Conditions: Active Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.

Detailed description:

Arms:
arm 1: Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks arm 2: Placebo IM injection twice weekly for 12 weeks

Interventions: intervention 1: BG9418 (Interferon beta-1a) intervention 2: Placebo
Intervention descriptions: intervention 1: Avonex IM injection, self-administered per protocol intervention 2: Placebo IM injection, self-administered per protocol.

Protocol document: