Crohn's Disease
Conditions
Keywords
Certolizumab pegol, Cimzia, Phase 3, Crohn's disease, Pediatric, Kids, OHANA, CD
Brief summary
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
Interventions
DRUGCertolizumab pegol
* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.
DRUGAdalimumab
* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.
DRUGPlacebo
* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission based on total Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10.0 points at Week 26 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corticosteroid-free clinical remission at Week 26 | 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. |
| Clinical response at Week 26 and Week 52 | Week 26; 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. |
| Endoscopic remission at Week 26 | 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. |
| Clinical remission (modified) at Week 26 | 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. |
| Clinical remission (modified) at Week 52 | 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. |
| Incidence of serious Treatment Emergent Adverse Event (TEAEs) | From Baseline to the Safety Follow-Up visit (Week 166) | 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 |
| Incidence of TEAEs leading to permanent withdrawal of investigational medicinal product | From Baseline to the Safety Follow-Up visit (Week 166) | 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. |
| Clinical remission based on total PCDAI score ≤10.0 points at Week 52 | 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. |
Outcome results
None listed