Crohn's DiseasePhase 3NCT04643483
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Certolizumab pegol and Adalimumab in people with Crohn's Disease, run by UCB Biopharma SRL.
Trial summary
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Certolizumab pegol and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
- Conditions
- Crohn's Disease
- Being tested
- Certolizumab pegol, Adalimumab, Placebo
- Keywords
- Certolizumab pegol, Cimzia, Phase 3, Crohn's disease, Pediatric, Kids, OHANA, CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolDrug
- Pharmaceutical form: Solution for injection
- Route of administration: Subcutaneous
Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.
AdalimumabDrug
- Pharmaceutical form: Solution for injection
- Route of administration: Subcutaneous
Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.
PlaceboDrug
- Pharmaceutical form: Solution for injection
- Route of administration: Subcutaneous
Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Adalimumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 26
Secondary outcomes (8)
Clinical remission (modified) at Week 26
Clinical remission (modified) is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10 and the abdominal pain and stool frequency items in the PCDAI having scores of 0.
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 PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Measured: Week 26
Corticosteroid-free clinical remission at Week 26
Corticosteroid free clinical remission is defined as not taking corticosteroids after tapering, within 4 weeks prior to Week 26, and total PCDAI score ≤10.0 points and the abdominal pain and stool frequency items in the PCDAI having scores of 0 at Week 26.
Measured: Week 26
Clinical response at Week 26 and Week 52
Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. 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 PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Measured: Week 26; Week 52
Endoscopic remission at Week 26
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease [SES-CD] from 0 to 2, with a higher score indicating more disease activity. SES-CD is based on four endoscopic variables (presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis). Each of the four SES-CD variables is scored from 0 to 3, with the sum of the scores for each variable ranging from 0 to 15, except for the presence and extent of stenosis, which ranges from 0 to 11, yielding a total SES-CD score of 0-56.
Measured: Week 26
Clinical remission based on total PCDAI score ≤10.0 points at Week 52
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.
Measured: Week 52
Clinical remission (modified) at Week 52
Clinical remission (modified) is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10 and the abdominal pain and stool frequency items in the PCDAI having scores of 0.
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 PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Measured: Week 52
Incidence of serious Treatment Emergent Adverse Event (TEAEs)
A Serious Treatment Emergent Adverse Event is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline to the Safety Follow-Up visit (Week 166)
Incidence of TEAEs leading to permanent withdrawal of investigational medicinal product
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline to the Safety Follow-Up visit (Week 166)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study startJun 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643483
- Sponsor's protocol ID
- CD0003
- Status last verified
- Jun 2021
- First submitted
- 19 Nov 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this trial 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT04643483
- Acronym / sponsor ID
- CD0003
- Conditions
- Crohn's Disease
- Keywords
- Certolizumab pegol, Cimzia, Phase 3, Crohn's disease, Pediatric, Kids, OHANA, CD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol low dose arm | Experimental | Drug: Certolizumab pegol, Drug: PlaceboParticipants 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. |
| Certolizumab pegol high dose arm | Experimental | Drug: Certolizumab pegol, Drug: PlaceboParticipants 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. |
| Adalimumab reference arm | Active comparator | Drug: Adalimumab, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Certolizumab pegol high dose arm, Certolizumab pegol low dose arm |
| Adalimumab* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods. | Drug | Adalimumab reference arm |
| Placebo* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive placebo in a pre-specified sequence during the Treatment Periods. | Drug | Adalimumab reference arm, Certolizumab pegol high dose arm, Certolizumab pegol low dose arm |
Primary outcome
Clinical remission based on total Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10.0 points at Week 26
Time frame: 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.
8 secondary outcomes
Clinical remission (modified) at Week 26
Time frame: Week 26
Corticosteroid-free clinical remission at Week 26
Time frame: Week 26
Clinical response at Week 26 and Week 52
Time frame: Week 26; Week 52
Endoscopic remission at Week 26
Time frame: Week 26
Clinical remission based on total PCDAI score ≤10.0 points at Week 52
Time frame: Week 52
Clinical remission (modified) at Week 52
Time frame: Week 52
Incidence of serious Treatment Emergent Adverse Event (TEAEs)
Time frame: From Baseline to the Safety Follow-Up visit (Week 166)
Incidence of TEAEs leading to permanent withdrawal of investigational medicinal product
Time frame: From Baseline to the Safety Follow-Up visit (Week 166)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: Yes. Data from this trial 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab pegol and Adalimumab in people with Crohn's Disease, run by UCB Biopharma SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.