Icotrokinra for Ulcerative Colitis

(ICONIC-UC Trial)

Recruiting at 46 trial locations

Overseen By Study Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Fulminant colitis, Toxic megacolon, Stoma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

882 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called icotrokinra for people with ulcerative colitis (UC), a chronic condition where the colon becomes inflamed and forms tiny ulcers. The trial aims to evaluate icotrokinra's effectiveness, safety, and tolerability. Participants will receive either icotrokinra or a placebo to compare results. This trial may suit individuals with moderately to severely active UC who have not responded well to previous treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that icotrokinra is likely to be safe for humans?

Research has shown that icotrokinra is generally safe for treating ulcerative colitis. In one study, patients who took 400 mg of icotrokinra daily for 12 weeks demonstrated a good safety record. About 63.5% of these patients showed improvement, compared to 27% of those who took a placebo (a pill with no active medicine). Another report found that icotrokinra remained safe for up to 28 weeks. These findings suggest that icotrokinra is well-tolerated, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, Icotrokinra targets a different pathway. This drug works by specifically modulating the immune system, potentially offering a new mechanism of action that could reduce inflammation more effectively. Researchers are excited because Icotrokinra is designed to be taken orally, which is more convenient than some current treatments that require injections or infusions. Additionally, it holds promise for both adult and adolescent patients, broadening its potential impact.

What evidence suggests that icotrokinra might be an effective treatment for ulcerative colitis?

In this trial, participants will receive either icotrokinra or a placebo to evaluate its effectiveness in treating ulcerative colitis. Studies have shown that icotrokinra can help treat this condition. By Week 12, 63.5% of patients taking icotrokinra experienced noticeable improvement, compared to only 27% of those taking a placebo. By Week 28, 31.7% of patients had significant positive results. The treatment also reduced symptoms and inflammation over time. These findings suggest that icotrokinra could be a promising option for people with ulcerative colitis. ^{2 3 4 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults and adolescents with moderate to severe ulcerative colitis, a chronic inflammation of the colon. Participants must meet specific health criteria not detailed here.

Inclusion Criteria

An endoscopy subscore >= 2 as obtained during central review of the screening video endoscopy

My ulcerative colitis is moderate to severe, based on a specific score.

I am a teenager weighing at least 40 kg.

Exclusion Criteria

I do not have severe ulcerative colitis complications that could need surgery during the study.

I have a stoma.

I have or had a fistula.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive icotrokinra or placebo daily, orally, to evaluate clinical response

12 weeks

Maintenance

Participants who respond to induction therapy continue to receive icotrokinra or placebo daily, orally

40 weeks

Long-term Extension (LTE)

Eligible participants can continue treatment in a long-term extension phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Icotrokinra

Trial Overview The study tests oral icotrokinra against a placebo to see how well it works and its safety in treating ulcerative colitis. It's likely randomized, meaning patients are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Open-label (OL) Induction Phase: Icotrokinra Experimental Treatment 1 Intervention

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.

Group II: OL Maintenance Phase: Icotrokinra Experimental Treatment 1 Intervention

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.

Group III: Double-blind (DB) Induction Study: Icotrokinra Experimental Treatment 1 Intervention

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.

Group IV: DB Maintenance Study: Icotrokinra Experimental Treatment 1 Intervention

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).

Group V: DB Induction Study: Placebo Placebo Group 1 Intervention

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.

Group VI: DB Maintenance Study: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. jnj.com jnj.com/media-center/press-releases/icotrokinra-maintains-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-through-28-weeks-in-ulcerative-colitis

Icotrokinra maintains standout combination of therapeutic ... Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical ...

2. prnewswire.com prnewswire.com/news-releases/icotrokinra-data-in-ulcerative-colitis-show-potential-for-a-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-302576329.html

Icotrokinra data in ulcerative colitis show potential for a ... At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/products/icotrokinra/medical-content/icotrokinra-treatment-of-ulcerative-colitis-anthemuc

Icotrokinra – Treatment of Ulcerative Colitis (ANTHEM-UC) Relative to week 12 outcomes, rates of clinical response, clinical remission, endoscopic improvement, and HEMI continued to increase through week 28 in each ...

4. delawareonline.com delawareonline.com/press-release/story/80100/protagonist-announces-new-icotrokinra-data-in-ulcerative-colitis-and-plaque-psoriasis-presented-at-two-recent-medical-conferences/

Protagonist Announces New Icotrokinra Data in Ulcerative ... Icotrokinra demonstrated clinically meaningful outcomes at Week 28 in the Phase 2b ANTHEM-UC study in ulcerative colitis, with 31.7% of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07196748

NCT07196748 | A Protocol of Icotrokinra Therapy in Adult ... IBDQ remission is defined as an IBDQ total score of >= 170. ... Scores range from 32 to 224, with higher scores indicating better outcomes. At ...

6. jnj.com jnj.com/media-center/press-releases/icotrokinra-data-in-ulcerative-colitis-show-potential-for-a-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill

Icotrokinra data in ulcerative colitis show potential for a ... At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), ...