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New study tracks how well risankizumab tames ulcerative colitis in daily life

NCT ID NCT07136116

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study follows 200 adults in Japan with moderate to severe ulcerative colitis who are already prescribed risankizumab by their doctor. Researchers will track how well the drug controls symptoms like diarrhea and rectal bleeding over up to 156 weeks. The goal is to see if the benefits seen in clinical trials hold up in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
risankizumab
What this could lead to
If successful, this study could confirm that risankizumab effectively controls ulcerative colitis symptoms in everyday clinical practice, helping doctors and patients make better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It only includes people already prescribed the drug, and long-term effectiveness or rare side effects may not be fully captured.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adult participants with moderate to severe UC who are being treated with RZB according to the relevant approved license and who are eligible according to the study eligibility criteria.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC) commenced on Risankizumab (RZB) treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines. * The decision to prescribe RZB is made prior to and independently of study participation. * Participants able to provide voluntary informed consent before any study-related activities or procedures (obtained/documented as per regulations). If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent. * Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB. * Participants without previous exposure to RZB. * Participants who are not currently participating in interventional research (not including non-interventional studies, PMOS, or registry participation). Exclusion Criteria: See Inclusion Criteria

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Medical University Hospital /ID# 278155

    RECRUITING

    Nagakute, Aichi-ken, 480-1195, Japan

  • Chiba University Hospital /ID# 277669

    RECRUITING

    Chiba, Chiba, 260-8677, Japan

  • Dokkyo Medical University Hospital /ID# 278152

    RECRUITING

    Mibu, Tochigi, 321-0293, Japan

  • Fukuoka University Hospital /ID# 277677

    RECRUITING

    Fukuoka, 814-0180, Japan

  • Hamamatsu University Hospital /ID# 277539

    RECRUITING

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hirosaki University Hospital /ID# 278153

    RECRUITING

    Hirosaki, Aomori, 036-8563, Japan

  • Hiroshima University Hospital /ID# 277542

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital /ID# 277668

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hyogo Medical University Hospital /ID# 277676

    RECRUITING

    Nishinomiya-shi, Hyōgo, 663-8501, Japan

  • Institute of Science Tokyo Hospital /ID# 277538

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Kansai Medical University Hospital /ID# 278619

    RECRUITING

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kitasato University Kitasato Institute Hospital /ID# 278154

    RECRUITING

    Minato-ku, Tokyo, 108-8642, Japan

  • Kobe University Hospital /ID# 278292

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • Kyorin University Hospital /ID# 277534

    RECRUITING

    Mitaka-shi, Tokyo, 181-8611, Japan

  • Kyushu University Hospital /ID# 278077

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • NHO Shizuoka Medical Center /ID# 278075

    RECRUITING

    Sunto-gun, Shizuoka, 411-8611, Japan

  • Nagoya University Hospital /ID# 278159

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • Okayama University Hospital /ID# 281615

    RECRUITING

    Okayama, Okayama-ken, 700-8558, Japan

  • Saga University Hospital /ID# 278160

    RECRUITING

    Saga, Saga-ken, 849-8501, Japan

  • Saitama Medical Center /ID# 278076

    RECRUITING

    Kawagoe, Saitama, 350-8550, Japan

  • Sapporo Higashi Tokushukai Hospital /ID# 278123

    RECRUITING

    Sapporo, Hokkaido, 065-0033, Japan

  • Sapporo Kosei General Hospital /ID# 278048

    RECRUITING

    Sapporo, 060-0033, Japan

  • Sapporo Medical University Hospital /ID# 277535

    RECRUITING

    Sapporo, Hokkaido, 060-8543, Japan

  • Shiga University of Medical Science Hospital /ID# 277540

    RECRUITING

    Ōtsu, Shiga, 520-2192, Japan

  • The Jikei University Hospital /ID# 278122

    RECRUITING

    Tokyo, 105-8461, Japan

  • Toho University Sakura Medical Center /ID# 277536

    RECRUITING

    Sakura, Chiba, 285-0841, Japan

  • Toyama University Hospital /ID# 277675

    RECRUITING

    Toyama, 930-0194, Japan

  • Tsujinaka Hospital - Kashiwanoha /ID# 277672

    RECRUITING

    Kashiwa-shi, Chiba, 277-0871, Japan

  • University Hospital Kyoto Prefectural University of Medicine /ID# 277541

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

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