A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Conditions

• Colitis, Ulcerative

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Icotrokinra — DRUG
  Icotrokinra tablet will be administered orally.
• Placebo — DRUG
  Placebo tablet will be administered orally.

Study Details

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Key Dates

Start date

Oct 1, 2025

Status verified

Jun 2026

Primary completion

Jan 14, 2028

Completion

Jan 13, 2032

Study Design

Enrollment

882 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blind (DB) Induction Study: Icotrokinra
  Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
• Placebo Comparator: DB Induction Study: Placebo
  Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
• Experimental: DB Maintenance Study: Icotrokinra
  Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
• Placebo Comparator: DB Maintenance Study: Placebo
  Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
• Experimental: Open-label (OL) Induction Phase: Icotrokinra
  Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
• Experimental: OL Maintenance Phase: Icotrokinra
  Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.

Primary Outcome Measure

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [ Time Frame: At Week I-12 ]

Central Contacts

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

Locations (54)

Find similar trials in Chandler, AZ

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