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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2026-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.

Placebo

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

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.

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.

Placebo

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

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.

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.

Placebo

Intervention Type DRUG

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

Interventions

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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.

Intervention Type DRUG

Adalimumab

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.

Intervention Type DRUG

Placebo

* Pharmaceutical form: Solution for injection
* Route of administration: Subcutaneous

Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No