Crohn Disease
Conditions
Interventions
1. Experimental: Induction Study 1: Icotrokinra Dose 1
Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12.Subsequent treatment will be determined by the participants respo
Sponsors
Sakamoto Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD - 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 - 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 - 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 - Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naive) 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: - 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 - Presence of a stoma or ostomy - Participants with presence of active fistulas may be included if there is no surgery needed - Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline - 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. Induction Study 1: Number of Participants with Clinical Response at Week 12 Clinical response is defined as a greater than or equal to (>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. [Time Frame: At Week 12] 2. Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) Clinical remission is defined as CDAI score less than () 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. [Time Frame: At Week 12] 4. Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) Clinical remission is defined as CDAI score 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. [Time Frame: At Week 40] | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed