Chron's disease - granulomatous enteritis
Conditions
Interventions
Study intervention will be administered at Weeks 0, 4, and 8 during the 12-week
open-label induction
phase. The induction dose regimen will be as follows:
- Participants >=10 to =25 to =40 kg: random
Sponsors
Janssen-Cilag
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Age 1. 2 to 30). 5. Have endoscopy with evidence of active CD defined as SES-CD score >=6 (or >=4 for participants with isolated ileal disease) within 4 weeks of receiving study intervention at Week 0. 6. Body weight >=10 kg at the time of consent for screening. Please refer to the Master protocol for more inclusion criteria, section 5.1.
Exclusion criteria
Exclusion criteria: 1. Has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of the treatment. Of note, surgical procedures related to fistula treatment are not necessarily exclusionary; discuss with medical monitor. 2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to Week 0, or 8 weeks prior to Week 0 for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. 3. Has had any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline. 4. Presence of a stoma, ileoanal pouch, or ostomy. 5. Has high grade dysplasia, history of or current evidence of polypoid or non-polypoid dysplasia, or any adenoma that has not been removed. Please refer to the Master protocol for more exclusion criteria, section 5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters for Platform-Level Exploratory Analysis • Proportion of participants achieving clinical remission (PCDAI) at Week 52 AND • Proportion of participants achieving endoscopic response (SES-CD) at Week 52 Primary global parameters • Clinical remission at Week 52 (defined as PCDAI score =50% reduction from SES-CD score at baseline) at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Global parameters • Clinical response (decrease from baseline/LOR reference in the PCDAI score >=12.5; total score =50% reduction from SES-CD score at baseline) at Week 52 | — |
Countries
Netherlands
Outcome results
None listed