Moderate to Severe Crohn's disease, Plaque psoriasis Digestive System
Conditions
Interventions
In Induction Study 1, participants are assigned to one of three arms. In the first experimental arm, participants will receive Icotrokinra Dose 1 up to Week 12. Subsequent treatment will be determined
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD 2. Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but =4, or mean daily AP score >=2 3. Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments 4. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests 5. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD (ADT-inadequate responder [IR]) as defined in the protocol
Exclusion criteria
Exclusion criteria: 1. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention 2. Presence of a stoma or ostomy 3. Participants with presence of active fistulas may be included if there is no surgery needed 4. Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline 5. Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical response is measured using the Mayo Clinic Score at baseline and Week 12 2. Clinical remission is measured using the Mayo Clinic Score at baseline and Week 12 3. Endoscopic response is measured using central reading of endoscopic images scored by the Mayo Endoscopic Subscore at baseline and Week 12 4. Clinical remission is measured using the Mayo Clinic Score at baseline, Week 12, and Week 52 (Maintenance Week 40) 5. Endoscopic response is measured using central reading of endoscopic images scored by the Mayo Endoscopic Subscore at baseline, Week 12, and Week 52 (Maintenance Week 40) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical remission is measured using the Mayo Clinic Score at baseline, Week I-4, and Week I-12 2. Clinical response is measured using the Mayo Clinic Score at baseline, Week I-4, and Week I-12 3. Endoscopic response is measured using central reading of endoscopic images scored by the Mayo Endoscopic Subscore at baseline and Week I-12 4. Endoscopic remission is measured using central reading of endoscopic images scored by the Mayo Endoscopic Subscore at baseline and Week I-12 5. Deep remission is measured using a composite of clinical remission and endoscopic remission at baseline and Week I-12 6. Clinical remission and endoscopic response is measured using a composite of Mayo Clinic Score and Mayo Endoscopic Subscore at baseline and Week I-12 7. PRO-2 remission is measured using the PRO-2 questionnaire at baseline and Week I-12 8. IBDQ remission is measured using the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline and Week I-12 9. Fatigue response is measured using the FACIT-Fatigue Scale at baseline and Week I-12 10. Dose-response is measured using change in Mayo Clinic Score across Icotrokinra doses at baseline and Week I-12 11. Frequency and type of adverse events (AEs) and serious adverse events (SAEs) are measured using investigator-reported safety data at baseline, Week I-12, and Week M-40 12. PRO-2 remission is measured using the PRO-2 questionnaire at baseline and Week M-40 13. Endoscopic remission is measured using central reading of endoscopic images scored by the Mayo Endoscopic Subscore at baseline and Week M-40 14. 90-day corticosteroid-free clinical remission is measured using the Mayo Clinic Score and corticosteroid use records at baseline and Week M-40 15. Maintenance of clinical remission is measured using the Mayo Clinic Score at Week M-0 and Week M-40 16. Clinical remission and endoscopic response is measured using a composite of Mayo Clinic Score and Mayo Endoscopic Subscore at baseline and Week M-40 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, England, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, Scotland, Spain, Switzerland, Taiwan, United Kingdom
Contacts
Public Contact. Janssen UK Registry
Outcome results
None listed