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ICOTROKINRA

Clinical trials are studying ICOTROKINRA in people with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. These studies look at how well it works and how safe it is in adults and adolescents with moderately to severely active disease. The trials also measure remission, response, and endoscopic outcomes.

Table of Contents

Trial overview

These studies are testing ICOTROKINRA in people with inflammatory bowel disease, which is a group of long-term diseases that cause swelling and irritation in the digestive tract.[1] The trial data show two authorised interventional studies, one in ulcerative colitis and one in Crohn’s disease.[1][2]

An interventional study means the researchers give a study treatment and compare results with placebo or another study group.[1][2] The main goal is to see whether ICOTROKINRA helps people reach clinical remission, clinical response, and other signs of improvement.[1][2]

Ulcerative colitis study

The ulcerative colitis trial is titled Efficacy and Safety of Icotrokinra in Adult and Adolescent Participants with Moderately to Severely Active Ulcerative Colitis.[1] It is a Phase 3 study with 882 participants and is currently authorised.[1]

This study includes three parts: an adult induction study, an adult maintenance study, and an adolescent study.[1] Induction means the first part of treatment, where researchers check whether the study treatment can bring symptoms under control.[1] Maintenance means the later part, where researchers check whether the benefit can be kept over time.[1]

The adult induction part compares ICOTROKINRA with placebo to see if it can induce clinical remission by Week 12.[1] The adult maintenance part looks at whether remission can be maintained by Week 40 in participants who first had a clinical response with ICOTROKINRA.[1]

The adolescent part also looks at maintenance and measures clinical remission by Week 40 in adolescents with moderately to severely active ulcerative colitis who first responded to ICOTROKINRA.[1] This means the study is not only checking short-term improvement, but also whether benefit can last in younger participants.[1]

Crohn’s disease study

The Crohn’s disease trial is titled Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease.[2] It is an authorised Phase 4 study with 1,090 participants.[2]

This trial includes a Phase 2b induction part and Phase 3 induction and maintenance parts.[2] The induction parts study whether ICOTROKINRA can help people improve at Week 12, while the maintenance part studies whether that benefit can continue to Week 40.[2]

For Phase 3 induction, the co-primary endpoints are clinical remission and endoscopic response at Week 12.[2] For Phase 3 maintenance, the co-primary endpoints are clinical remission and endoscopic response at Week 40.[2]

Endoscopic response means the bowel looks better on a scope test, which helps show whether inflammation inside the bowel has improved.[2]

Who can participate

The ulcerative colitis study includes adult and adolescent participants with moderately to severely active disease.[1] The Crohn’s disease study includes participants with moderately to severely active Crohn’s disease.[2]

Based on the trial data, the studies are focused on people whose disease is active enough to need research treatment and close follow-up.[1][2] The source data do not give full details about all entry rules, so the exact participation criteria are not listed here.[1][2]

What is being measured

The main outcome in the ulcerative colitis study is clinical remission at Week 12 for the adult induction part and at Week 40 for the adult and adolescent maintenance parts.[1] Clinical remission means the disease signs and symptoms are very low or absent.[1]

The Crohn’s disease study measures clinical response in the Phase 2b induction part at Week 12, and clinical remission plus endoscopic response in the Phase 3 induction and maintenance parts.[2] A clinical response means the person improves, even if they do not reach full remission.[2]

These outcomes help researchers understand both symptom improvement and bowel healing over time.[1][2]

Trial phases and status

The ulcerative colitis study is a Phase 3 trial and is authorised.[1] Phase 3 studies are usually larger studies that help confirm how well a treatment works.[1]

The Crohn’s disease study is a Phase 4 trial and is also authorised.[2] It includes Phase 2b and Phase 3 parts inside the same research program, which allows researchers to study different stages of treatment in one overall trial.[2]

Across both trials, the focus is on whether ICOTROKINRA can help people with active inflammatory bowel disease reach remission or clear improvement and keep that benefit over time.[1][2]

Trial ID Phase Condition studied Status Enrollment
2025-521381-10-00 Phase 3 Moderately to severely active ulcerative colitis Authorised 882
2025-521382-27-00 Phase 4 Moderately to severely active Crohn’s disease Authorised 1090

FAQ

  • What conditions are being studied with ICOTROKINRA? The trials are studying moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. These are long-term inflammatory bowel diseases that can cause ongoing gut inflammation.
  • Who can take part in the ICOTROKINRA trials? One trial includes adult and adolescent participants with ulcerative colitis. The other trial includes participants with Crohn’s disease who have moderately to severely active disease.
  • What phases are the ICOTROKINRA trials in? The ulcerative colitis trial is Phase 3. The Crohn’s disease trial is Phase 4, and it also includes a Phase 2b induction part and Phase 3 induction and maintenance parts.
  • What are the trials trying to find out? They are checking whether ICOTROKINRA can help people reach clinical remission or clinical response. Some parts of the Crohn’s disease study also measure endoscopic response, which means improvement seen during a scope exam.
  • What do the trial results measure? The main measures include clinical remission at Week 12 or Week 40, clinical response, and endoscopic response. These outcomes help show whether symptoms and bowel inflammation improve over time.

Ongoing Clinical Trials on ICOTROKINRA

  • Study of icotrokinra for adults with moderately to severely active Crohn’s disease

    Recruiting

    4 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Hungary +7

  • Testing icotrokinra compared to placebo for adults and adolescents with moderately to severely active ulcerative colitis

    Recruiting

    3 1
    Investigated drugs:
    Belgium Czechia France Germany Greece Hungary +7

Glossary

  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the large intestine and rectum.
  • Crohn’s disease: A long-term disease that can cause inflammation anywhere in the digestive tract, often with pain, diarrhea, and other symptoms.
  • Moderately to severely active: A term used when disease symptoms and inflammation are strong enough to need advanced treatment and close study.
  • Clinical trial: A research study in people that tests whether a treatment is safe and works as expected.
  • Interventional study: A study where researchers give a treatment or placebo and compare results.
  • Phase 2b: An early mid-stage trial that helps researchers learn more about whether a treatment works.
  • Phase 3: A larger trial that compares a treatment with placebo or another treatment to confirm how well it works.
  • Phase 4: A later-stage study done after a treatment is already being studied more widely.
  • Clinical remission: A period when signs and symptoms of the disease are very low or not present.
  • Clinical response: An improvement in symptoms, but not always full remission.
  • Endoscopic response: Improvement seen during a scope test that looks inside the bowel.
  • Placebo: An inactive tablet used for comparison in a trial.

References

  1. https://clinicaltrials.gov/study/2025-521381-10-00
  2. https://clinicaltrials.gov/study/2025-521382-27-00