Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222598

Enrollment

Registered

2014-09-03

Start date

2014-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerateive Colotis

Interventions

investigational material(s) Generic name etc : abalimumab INN of investigational material : Adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of Ulcerative Colitis (UC) for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy. Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

Exclusion criteria

Exclusion criteria: Subject with Crohn's disease (CD) or indeterminate colitis (IC). Current diagnosis of fulminant colitis and/or toxic megacolon. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. Chronic recurring infections or active Tuberculosis (TB).

Design outcomes

Primary

Measure	Time frame
safety efficacy pharmacokinetics Percentage of participants who achieve clinical remission per partial Mayo score (PMS) [ Time Frame: Week 8 ] Percentage of participants who responded at Week 8 per PMS and achieve clinical remission per Mayo score [ Time Frame: Week 52 ]	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Percentage of participants who achieve mucosal healing [ Time Frame: Week 52 ] Percentage of participants in Mayo clinical response in Week 8 responders [ Time Frame: Week 52 ] Percentage of participants who achieve Mayo clinical remission in Week 8 remitters [ Time Frame: Week 52 ] Percentage of participants receiving corticosteroid at Baseline who have discontinued corticosteroid prior to Week 52 and are in Mayo clinical remission in Week 8 responders [ Time Frame: Week 52 ] Partial Mayo Score, Mayo endoscopy subscore	—

Measure

Time frame

safety efficacy pharmacokinetics Percentage of participants who achieve mucosal healing [ Time Frame: Week 52 ] Percentage of participants in Mayo clinical response in Week 8 responders [ Time Frame: Week 52 ] Percentage of participants who achieve Mayo clinical remission in Week 8 remitters [ Time Frame: Week 52 ] Percentage of participants receiving corticosteroid at Baseline who have discontinued corticosteroid prior to Week 52 and are in Mayo clinical remission in Week 8 responders [ Time Frame: Week 52 ] Partial Mayo Score, Mayo endoscopy subscore

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Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026