NCT00616434 is a Phase 2 clinical trial of BG9418 (Interferon beta-1a) in Active Ulcerative Colitis, sponsored by Biogen.

Who is sponsoring NCT00616434?

NCT00616434 is sponsored by Biogen.

What drugs are being tested in NCT00616434?

Interventions in NCT00616434: BG9418 (Interferon beta-1a), Placebo.

What condition does NCT00616434 study?

NCT00616434 studies Active Ulcerative Colitis.

Is NCT00616434 still recruiting?

NCT00616434 is currently completed. Last updated 23 July 2014.

Are results published for NCT00616434?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-07-23 · How we verify

NCT00616434

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis

Completed Phase 2 Results posted Last updated 23 July 2014

What this trial tests

Phase 2 trial testing BG9418 (Interferon beta-1a) in Active Ulcerative Colitis in 123 participants. Completed in 1 March 2010.

Timeline

1 May 2008

Primary endpoint
1 March 2010

1 March 2010

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	123
Start date	1 May 2008
Primary completion	1 March 2010
Estimated completion	1 March 2010
Sites	35 locations across United States, Canada, Czechia, Hungary, Poland, Russia, Slovakia

Drugs / interventions tested

BG9418 (Interferon beta-1a) — full drug profile →
Placebo

Conditions studied

Active Ulcerative Colitis — all drugs for Active Ulcerative Colitis →

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 65, any sex, with Active Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With a Clinical Response
Time frame: Baseline and Week 8
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessmen

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.
Lu Q, Yang MF, Liang YJ, Xu J, et al · · 2022 · cited 139× · PMID 35310454 · DOI 10.2147/jir.s353038
Interferon therapy and its association with depressive disorders - A review.
Lai JY, Ho JX, Kow ASF, Liang G, et al · · 2023 · cited 28× · PMID 36911685 · DOI 10.3389/fimmu.2023.1048592
Type I interferons for induction of remission in ulcerative colitis.
Wang Y, MacDonald JK, Benchimol EI, Griffiths AM, et al · · 2015 · cited 12× · PMID 26368001 · DOI 10.1002/14651858.cd006790.pub3

Verify or expand the search:

Other recruiting trials for Active Ulcerative Colitis

Currently open trials in the same condition.

NCT06681389 — A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative · Phase 1 · recruiting
NCT05739864 — Superdonor FMT in Patients With Ulcerative Colitis · Phase 1, PHASE2 · recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00616434 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 23 July 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00616434.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing