A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With

General Information:

Study Objective

To evaluate the safety and efficacy of an oral investigational medication in people with moderately to severely active ulcerative colitis.

Phase of study

Phase 3

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Eligibility:

Age

Adult (18+)

Pediatric (under 18)

Gender

Female

Male

Disease Type

Ulcerative Colitis

Severity

Moderate

Severe

Eligibility Criteria

Inclusion Criteria:

Are at least 12 years old
Be diagnosed with UC for at least 3 months
Have moderately to severely active UC
Have not been able to tolerate or have not improved with a current or previous treatment for your UC
There are other criteria needed to qualify for study enrollment, which your study doctor will discuss with you.

*Participants under the age of 18 require permission from a parent or caregiver to participate

Exclusion Criteria:

Have complications of UC that may require surgery
Currently enrolled in another study using an investigational agent, device, or procedure

There are other exclusion criteria that could result in your ineligibility for this study, which your study doctor will discuss with you.

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Study Details:

Study description/explanation of participation:

ICONIC-UC is evaluating the safety and efficacy of an oral investigational medication for moderately to severely active ulcerative colitis. The investigational medication is a tablet (or pill) that is taken by mouth once a day. The investigational medication will be compared to placebo in adults. Placebo looks like the investigational medication but contains no active medication. Adolescents will only receive the investigational medication. There are 5 parts to this study. If you complete all 5 parts, your participation in the ICONIC-UC study will last up to 5 years (approximately 270 weeks). The safety and efficacy of the investigational medication have not been established.

Patient Participation:

Come to all study visit appointments and complete required assessments.
Complete an electronic diary and bring it with you to appointments
Tell the study doctor/staff about any health problems you have during the study
Tell the study staff about any new medicine or drug you take during the study, including over-the-counter drugs.
Tell the study staff about any changes to your ongoing medicines or drugs.

Possible risks and side effects:

Because we are learning about the study medication, all possible side effects and risks related to the study medication are not known and there is the potential that you may experience side effects. All potential side effects will be discussed by the study staff before you begin the study.

Side effects may range from mild and unpleasant to serious, or even life threatening. If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored.

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Contact Information:

Site Locations

Clinnova Research 100 S Anaheim Blvd Suite 250 Anaheim, California 92805

Prahar Parikh