A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Crohn Disease

Treatments: Drug: Icotrokinra; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07196722

77242113CRD3001 (Other Identifier)

2025-521382-27-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Enrollment: 1,092 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <=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]-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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,092 participants in 8 patient groups, including a placebo group

Induction Study 1: Icotrokinra Dose 1

Experimental group

Description:

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.

Treatment:

Drug: Icotrokinra

Induction Study 1: Icotrokinra Dose 2

Experimental group

Description:

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.

Treatment:

Drug: Icotrokinra

Induction Study 1: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Induction Study 2: Icotrokinra

Experimental group

Description:

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.

Treatment:

Drug: Icotrokinra

Induction Study 2: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Maintenance Study: Icotrokinra Dose 1

Experimental group

Description:

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 eligibile 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).

Treatment:

Drug: Icotrokinra

Maintenance Study: Icotrokinra Dose 2

Experimental group

Description:

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.

Treatment:

Drug: Icotrokinra

Maintenance Study: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Icotrokinra