A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

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.