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

NCT04643483 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: CD0003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Crohn's Disease

Keywords

Certolizumab pegol; Cimzia; Phase 3; Crohn's disease; Pediatric; Kids; OHANA; CD

Outcome Measures

Primary Outcomes (1)

• Clinical remission based on total Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10.0 points at Week 26

  Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a total PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.

  Week 26

Secondary Outcomes (8)

• Clinical remission (modified) at Week 26

  Week 26

• Corticosteroid-free clinical remission at Week 26

  Week 26

• Clinical response at Week 26 and Week 52

  Week 26; Week 52

• Endoscopic remission at Week 26

  Week 26

• Clinical remission based on total PCDAI score ≤10.0 points at Week 52

  Week 52

Study Arms (3)

Certolizumab pegol low dose arm

EXPERIMENTAL

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.

Drug: Certolizumab pegol; Drug: Placebo

Certolizumab pegol high dose arm

EXPERIMENTAL

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.

Drug: Certolizumab pegol; Drug: Placebo

Adalimumab reference arm

ACTIVE COMPARATOR

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.

Drug: Adalimumab; Drug: Placebo

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.

Certolizumab pegol high dose arm; Certolizumab pegol low dose arm

Adalimumab DRUG

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

Adalimumab reference arm

Placebo 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; Certolizumab pegol high dose arm; Certolizumab pegol low dose arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: 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

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: June 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: April 1, 2026
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.