A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
Condition: Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BG9418 (Interferon beta-1a); Placebo
Intervention description: Avonex IM injection, self-administered per protocol; Placebo IM injection, self-administered per protocol.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Established diagnosis of ulcerative colitis (UC) for ≥6 months

               -  20 cm active disease at Screening endoscopy

          -  Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points
             and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2)
             despite prior or concomitant treatment

          -  Colonoscopy within past 5 years for extent of disease and to exclude polyps

          -  For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies
             within 1 year prior to Screening to exclude dysplasia and neoplasia.

          -  Must be willing and able to practice effective birth control during the study and for
             1 month after the last dose of study treatment.

        Key Exclusion Criteria:

          -  Diagnosis of indeterminate colitis or Crohn's disease

          -  Need for imminent surgery

          -  Diagnosis of primary sclerosing cholangitis or toxic megacolon

          -  Hemoglobin ≤9 g/dL

          -  White blood cell count < 3500 cells/mm^3

          -  Lymphocyte count <1000 cells/µL

          -  Platelet count <100,000 cells/µL

          -  Female subjects who are pregnant or who wish to become pregnant during the study, or
             who are lactating

          -  Known symptomatic colonic stricture

          -  Stool cultures positive for enteric infection

          -  History of malignant disease

          -  History of major abdominal surgery (e.g., gastrectomy) within past 5 years

          -  History of small bowel or colonic obstruction or resection

          -  History of drug or alcohol abuse (as defined by the Investigator) within 2 years prior
             to Screening

          -  Use of anti-diarrheal agents during the screening period

          -  Previous participation in this study

          -  Previous treatment with interferon beta or other interferon products

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.