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

Biogen

Status and phase: Completed; Phase 2

Conditions: Active Ulcerative Colitis

Treatments: Drug: Placebo; Drug: BG9418 (Interferon beta-1a)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616434

2007-004867-22 (EudraCT Number)

108UC201

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

123 participants in 2 patient groups, including a placebo group

Interferon beta-1a

Experimental group

Description:

Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks

Treatment:

Drug: BG9418 (Interferon beta-1a)

Placebo

Placebo Comparator group

Description:

Placebo IM injection twice weekly for 12 weeks

Treatment:

Drug: Placebo