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A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease

NCT04643483 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-06-23

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Certolizumab pegol

* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.

DRUG

Adalimumab

* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.

DRUG

Placebo

* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-09-30
Completion
2026-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643483 on ClinicalTrials.gov