A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003032-77-HU

Enrollment

225

Registered

2013-12-30

Start date

2014-12-04

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

Ulcerative colitis MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subjects from the ages of 4 to 17 prior to baseline dosing. ? Diagnosis of 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 Are the trial subjects under 18? yes Number of subjects for this age range: 225 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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 TB

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).;Secondary Objective: not applicable;Primary end point(s): ? The proportion of subjects who achieve clinical remission at Week 8 as measured by PMS ? The proportion of subjects who responded at Week 8 per PMS and achieve clinical remission at Week 52 as measured by Mayo score;Timepoint(s) of evaluation of this end point: Week 8, Week 52	—

Measure

Time frame

Main Objective: To demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).;Secondary Objective: not applicable;Primary end point(s): ? The proportion of subjects who achieve clinical remission at Week 8 as measured by PMS ? The proportion of subjects who responded at Week 8 per PMS and achieve clinical remission at Week 52 as measured by Mayo score;Timepoint(s) of evaluation of this end point: Week 8, Week 52

—

Secondary

Measure	Time frame
Secondary end point(s): ? Proportion of subjects who achieve mucosal healing at Week 52 as measured by Mayo endoscopy subscore (defined as = 1) in Week 8 responders per PMS ? Proportion of subjects in PUCAI remission (defined as < 10) in Week 8 responders per PMS at Week 52 ;Timepoint(s) of evaluation of this end point: Week 52	—

Countries

Australia, Austria, Belgium, Canada, Czech Republic, France, Hungary, Israel, Italy, New Zealand, Poland, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026