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A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Crohn's Disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502050-14-00
Acronym
M16-194
Enrollment
59
Registered
2024-01-16
Start date
2024-06-04
Completion date
Unknown
Last updated
2026-01-16

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

Conditions

Crohn's disease

Brief summary

PK Leading Cohort 1 and Cohort 2: Cmax, Tmax and AUCtau of risankizumab., Cohort 3: •Achievement of clinical remission per PCDAI at Week 64 (SS2). •Achievement of endoscopic response at Week 64 (SS2).

Detailed description

PK Leading Cohort 1 and Cohort 2: •Achievement of clinical remission per PCDAI at Week 64 (SS2). •Achievement of endoscopic response at Week 64 (SS2). •Achievement of clinical remission per PCDAI at Week 12 (SS1). •Achievement of endoscopic response at Week 12 (SS1). •Achievement of endoscopic remission at Week 12 (SS1). •Achievement of endoscopic remission at Week 64 (SS2). •Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2)., Cohort 3: 1. Achievement of clinical remission per PCDAI at Week 12 (SS1). 2. Achievement of endoscopic response at Week 12 (SS1). 3. Achievement of endoscopic remission at Week 12 (SS1). 4. Achievement of endoscopic remission at Week 64 (SS2). 5. Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2).

Interventions

DRUGMatching placebo for 180 mg solution for injection
DRUGABBV-066
DRUGABBV-066 / Risankizumab
DRUGMatching Placebo for 90 mg solution for injection
DRUGRisankizumab

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
PK Leading Cohort 1 and Cohort 2: Cmax, Tmax and AUCtau of risankizumab., Cohort 3: •Achievement of clinical remission per PCDAI at Week 64 (SS2). •Achievement of endoscopic response at Week 64 (SS2).—

Secondary

MeasureTime frame
PK Leading Cohort 1 and Cohort 2: •Achievement of clinical remission per PCDAI at Week 64 (SS2). •Achievement of endoscopic response at Week 64 (SS2). •Achievement of clinical remission per PCDAI at Week 12 (SS1). •Achievement of endoscopic response at Week 12 (SS1). •Achievement of endoscopic remission at Week 12 (SS1). •Achievement of endoscopic remission at Week 64 (SS2). •Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2)., Cohort 3: 1. Achievement of clinical remission per PCDAI at Week 12 (SS1). 2. Achievement of endoscopic response at Week 12 (SS1). 3. Achievement of endoscopic remission at Week 12 (SS1). 4. Achievement of endoscopic remission at Week 64 (SS2). 5. Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2).—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026