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A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Crohn Disease
Date of first enrollment	03/12/2025
Target sample size	1092
Countries of recruitment
Study type	Interventional
Intervention(s)	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 participant's response status at Week 12. Drug: Icotrokinra Icotrokinra will be administered orally, daily. Other names: JNJ-77242113 2. Experimental: Induction Study 1: Icotrokinra Dose 2 Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12. Drug: Icotrokinra Icotrokinra will be administered orally, daily. Other names: JNJ-77242113 3. Placebo Comparator: Induction Study 1: Placebo Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12. Drug: Placebo Matching placebo will be administered orally, daily. 4. Experimental: Induction Study 2: Icotrokinra Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12. Drug: Icotrokinra Icotrokinra will be administered orally, daily. Other names: JNJ-77242113 5. Placebo Comparator: Induction Study 2: Placebo Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12. Drug: Placebo Matching placebo will be administered orally, daily. 6. Experimental: Maintenance Study: Icotrokinra Dose 1 Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long term extension (LTE). Drug: Icotrokinra Icotrokinra will be administered orally, daily. Other names: JNJ-77242113 7. Experimental: Maintenance Study: Icotrokinra Dose 2 Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE. Drug: Icotrokinra Icotrokinra will be administered orally, daily. Other names: JNJ-77242113 8. Placebo Comparator: Maintenance Study: Placebo Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE. Drug: Placebo Matching placebo will be administered orally, daily.

Outcome(s)

Primary Outcome

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 (<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. [Time Frame: At Week 12] 3. Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) Endoscopic response is defined as greater 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 < 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. [Time Frame: At Week 40] 5. Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) Endoscopic response is defined as > 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 Outcome

Refer to Appendix

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 <=450 and either mean daily SF count >=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
Exclude 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