Clinical trial NCT04643483: A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Certolizumab pegol
Cimzia
Phase 3
Crohn's disease
Pediatric
Kids
OHANA
CD
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in 3 parts:

* Part A will investigate 2 certolizumab pegol (CZP) dosing regimens with the objective of selecting a regimen that provides the highest rate of clinical remission. A cohort of participants will receive adalimumab (ADA) as a reference arm in Part A to assess clinical remission rates at Week 26 in this population. Endoscopic remission at Week 26 will also be evaluated
* Part B will assess maintenance of clinical remission from Week 26 through Week 52
* Part C is an optional open-label extension (OLE) of CZP after Part B, and will evaluate the long-term safety of CZP through Week 156
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol


Eligibility criteria: Inclusion Criteria:

* Participant must be 6 to 17 years, inclusive, at the time of signing informed consent/assent
* Participant has been diagnosed with active Crohn's disease (CD) as confirmed by endoscopic examination with/without histological confirmation ≤12 weeks before the Screening Visit
* Participant has moderately to severely active disease despite current treatment
* Participant has an inadequate response or intolerance to conventional therapy
* Participants are certolizumab pegol (CZP) and adalimumab (ADA) naïve

Exclusion Criteria:

* Participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of \>3 small bowel resections
* Participant has had a primary failure (ie, lack of response within the first 12 weeks of treatment) to any anti-Tumor necrosis factor-α agent for treatment of Crohn's disease

Primary outcomes:
measure: Clinical remission based on total Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10.0 points at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Clinical remission (modified) at Week 26
timeFrame: Week 26
measure: Corticosteroid-free clinical remission at Week 26
timeFrame: Week 26
measure: Clinical response at Week 26 and Week 52
timeFrame: Week 26; Week 52
measure: Endoscopic remission at Week 26
timeFrame: Week 26
measure: Clinical remission based on total PCDAI score ≤10.0 points at Week 52
timeFrame: Week 52
measure: Clinical remission (modified) at Week 52
timeFrame: Week 52
measure: Incidence of serious Treatment Emergent Adverse Event (TEAEs)
timeFrame: From Baseline to the Safety Follow-Up visit (Week 166)
measure: Incidence of TEAEs leading to permanent withdrawal of investigational medicinal product
timeFrame: From Baseline to the Safety Follow-Up visit (Week 166)
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: