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

Sponsor
UCB Biopharma SRL
Study ID
NCT04643483
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Certolizumab pegol — DRUG
    * Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.
  • Adalimumab — DRUG
    * Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.
  • Placebo — DRUG
    * Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

Study Details

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

Key Dates

Start date
Jun 30, 2021
Status verified
Jun 2021
Primary completion
Sep 30, 2023
Completion
Apr 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Certolizumab pegol low dose arm
    Participants randomized to certolizumab pegol (CZP) who weigh ≥17 kg to \<40 kg will receive placebo at Week 0 and a loading dose of 200 mg at Weeks 0, 2, and 4, followed by a maintenance dose of 100 mg CZP subcutaneously (sc) every 2 weeks (Q2W). Participants randomized to CZP who weigh ≥40 kg will receive placebo at Week 0 and a loading dose of 400 mg at Weeks 0, 2, and 4, followed by placebo and a maintenance dose of 200 mg CZP sc Q2W.
  • Experimental: Certolizumab pegol high dose arm
    Participants randomized to CZP who weigh ≥17 kg to \<40 kg will receive placebo at Week 0 and a loading dose of 200 mg at Weeks 0, 2, and 4, followed by a maintenance dose of 200 mg CZP sc Q2W. Participants randomized to CZP who weigh ≥40 kg will receive placebo at Week 0 and a loading dose of 400 mg at Weeks 0, 2, and 4, followed by a maintenance dose of 300 mg CZP sc Q2W.
  • Active Comparator: Adalimumab reference arm
    Participants randomized to adalimumab who weigh ≥17 kg to \<40 kg will receive a loading dose of 80 mg at Week 0 and 40 mg at Week 2, followed by a maintenance dose of 20 mg sc Q2W. Participants randomized to Adalimumab who weigh ≥40 kg will receive a loading dose of 160 mg at Week 0 and 80 mg at Week 2, 40 mg and placebo at week 4 followed by a maintenance dose of 40 mg sc and placebo Q2W.

Primary Outcome Measure

Clinical remission based on total Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10.0 points at Week 26 [ Time Frame: Week 26 ]

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