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

UCB

Status and phase: Withdrawn; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: Certolizumab pegol; Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04643483

CD0003

Details and patient eligibility

About

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

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Certolizumab pegol low dose arm

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Certolizumab pegol

Certolizumab pegol high dose arm

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Certolizumab pegol

Adalimumab reference arm

Active Comparator group

Description:

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.

Treatment:

Drug: Adalimumab

Drug: Placebo