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

Conditions

• Crohn Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Icotrokinra — DRUG
  Icotrokinra will be administered orally, daily.
• Placebo — DRUG
  Matching placebo will be administered orally, daily.

Study Details

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).

Key Dates

Start date

Oct 3, 2025

Status verified

Jun 2026

Primary completion

Sep 19, 2028

Completion

Oct 6, 2032

Study Design

Enrollment

1,092 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.
• 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.
• 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.
• 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 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).
• 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.
• 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.

Primary Outcome Measure

Induction Study 1: Number of Participants with Clinical Response at Week 12 [ Time Frame: At Week 12 ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (58)

Find similar trials in Chandler, AZ

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