NCT04643483WithdrawnPhase 3
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 23 Jun 2021
Reason given: Sponsor decision
Brief summary (registry, in English)
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 19 Nov 2020
- Start date
- Jun 2021
- Primary completion date
- Sept 2023
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Crohn's disease
- NCT number
- NCT04643483
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.