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New hope for ulcerative colitis: experimental drug enters human trials

NCT ID NCT06636656

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Updated 3 times

Summary

This study tests a new drug called BI 3032950 in 80 adults with moderate to severe ulcerative colitis who haven't improved on other treatments. In the first part, the drug is given by IV every 4 weeks for 12 weeks. Those who respond then receive injections under the skin every 4 weeks for up to 2 years. Doctors will check symptoms, perform endoscopies, and monitor for side effects.

What this could mean

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

Active substance
BI 3032950
What this could lead to
If successful, this could provide a new treatment option for people with ulcerative colitis who haven't responded to other therapies.
What could go wrong
This is an early Phase 2 trial with only 80 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

Dec 2024

Expected to finish

Jul 2029

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.

Ages

18 to 80 years

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 * Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent, * Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report, * Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason, * Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms, * Further inclusion criteria apply. Exclusion criteria * Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD), * Findings suggestive of CD (e.g. fistulae, granulomas on biopsy), * Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed, * Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture, * Evidence of fulminant colitis or toxic megacolon at screening, * Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine, * Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor), * Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery, * Further exclusion criteria apply.

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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

    41 sites in 6 countries. 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

  • Atrium Health Gastroenterology and Hepatology

    RECRUITING

    Charlotte, North Carolina, 28204-2963, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • CHC MontLegia

    RECRUITING

    Liège, 4000, Belgium

  • Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.

    RECRUITING

    Włocławek, 87-800, Poland

  • Centrum Medyczne Medyk Sp. z o.o.

    RECRUITING

    Rzeszów, 35-326, Poland

  • Centrum Medyczne Plejady

    RECRUITING

    Krakow, 30-363, Poland

  • Clinical Center Zemun

    NOT_YET_RECRUITING

    Belgrade, 11080, Serbia

  • Clinical Hospital Center Zvezdara

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Research Center Sp. z o.o. Medic-R sp.k.

    RECRUITING

    Poznan, 61-731, Poland

  • Columbia University Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032-3725, United States

  • Digestive Health Specialists

    RECRUITING

    Tacoma, Washington, 98405-2318, United States

  • EMC Instytut Medyczny S.A. - Poznan 70-304

    RECRUITING

    Poznan, 60-309, Poland

  • EMC Instytut Medyczny S.A. - Wroclaw

    RECRUITING

    Wroclaw, 54-239, Poland

  • ENDOMED s.r.o.

    RECRUITING

    Košice, 040 13, Slovakia

  • Endoskopia Sp. z o.o.

    RECRUITING

    Sopot, 81-756, Poland

  • Eskulap Pabianice Sp. z o.o.

    RECRUITING

    Pabianice, 95-200, Poland

  • F D Roosevelt University General Hospital Of Banska Bystrica

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Florida Research Institute

    RECRUITING

    Lakewood Rch, Florida, 34211, United States

  • Gastro I., s.r.o

    RECRUITING

    Prešov, 080 01, Slovakia

  • Gastromed Sp. z o.o.

    RECRUITING

    Torun, 87-100, Poland

  • General Hospital - Djordje Joanovic

    RECRUITING

    Zrenjanin, 23101, Serbia

  • Hepato-Gastroenterologie HK, s.r.o.

    NOT_YET_RECRUITING

    Hradec Králové, 500 12, Czechia

  • ISCARE a.s.

    RECRUITING

    Prague, 190 00, Czechia

  • Illinois Gastroenterology Group - Gurnee

    RECRUITING

    Gurnee, Illinois, 60031, United States

  • KM Management, spol. s.r.o.

    RECRUITING

    Nitra, 949 01, Slovakia

  • Medrise Sp. z o.o.

    RECRUITING

    Lublin, 20-582, Poland

  • Military Medical Academy

    NOT_YET_RECRUITING

    Belgrade, 11040, Serbia

  • NZOZ VIVAMED Jadwiga Miecz

    RECRUITING

    Warsaw, 03-580, Poland

  • One of a Kind Clinical Research Center

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • PlanetMed Sp. z o.o.

    RECRUITING

    Wroclaw, 52-210, Poland

  • Primary Care of Osceola

    NOT_YET_RECRUITING

    Kissimmee, Florida, 34741, United States

  • Pro Life Medica Sp. z o.o.

    RECRUITING

    Zamość, 22-400, Poland

  • Reliant Medical Research

    RECRUITING

    Miami, Florida, 33165-3639, United States

  • Synexus Polska Sp. z o.o.

    RECRUITING

    Warsaw, 02-672, Poland

  • Texas Digestive Disease Consultants

    RECRUITING

    Cedar Park, Texas, 78613, United States

  • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

    RECRUITING

    Szczecin, 71-434, Poland

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66103-2937, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Washington

    NOT_YET_RECRUITING

    Seattle, Washington, 98195-0001, United States

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