Overview

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.