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New hope for tough ulcerative colitis cases: spesolimab trial shows promise

NCT ID NCT03482635

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug called spesolimab in 98 adults with moderate-to-severe ulcerative colitis who did not get better with other biologic treatments. The goal was to see if the drug could safely reduce symptoms and help the colon heal. The trial was completed and looked at how many patients achieved remission after 12 weeks of treatment.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

98 people

The number who actually took part.

Started

Mar 2018

Finished

May 2020

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 75 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: * 18 - 75 years, at date of signing informed consent, males or females * Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report * Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose) * Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge) * Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study) * Further inclusion criteria apply Exclusion Criteria: * Evidence of abdominal abscess at screening * Evidence of fulminant colitis or toxic megacolon at screening * Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine * 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.

Colitis ulcerative

Contacts and locations

Locations

  • AKH - Medical University of Vienna

    Vienna, 1090, Austria

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033, United States

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • Barnsley Hospital

    Barnsley, S75 2EP, United Kingdom

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Central Clinical Hospital MSWiA, Internal Diseases, Warsaw

    Warsaw, 02-507, Poland

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112, United States

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT, United Kingdom

  • Emory University

    Atlanta, Georgia, 30322, United States

  • FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.

    Irkutsk, 664003, Russia

  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"

    Saint Petersburg, 194044, Russia

  • Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia

    Moscow, 123423, Russia

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Health Center of Mother, Child and Youth Sp.z o.o.

    Warsaw, 00-632, Poland

  • Hospital Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

  • Hyogo College of Medicine Hospital

    Hyogo, Nishinomiya, 663-8501, Japan

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • Kirov State Med.Univ. of MoH RF

    Kirov, 610027, Russia

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642, Japan

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730, Germany

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Ofuna Chuo Hospital

    Kanagawa, Kamakura, 247-0056, Japan

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, A-4010, Austria

  • Reg. Clin. Scientific Research Institute na Vladimiskiy

    Moscow, 129110, Russia

  • Sameshima Hospital

    Kagoshima, Kagoshima, 892-0846, Japan

  • Sapporo Higashi Tokushukai Hospital

    Hokkaido, Sapporo, 065-0033, Japan

  • Sapporo Tokushukai Hospital

    Hokkaido, Sapporo, 004-0041, Japan

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092, United States

  • The limited liability company "Clinic USI 4D"

    Pyatigorsk, 357502, Russia

  • Toho University Sakura Medical Center

    Chiba, Sakura, 285-8741, Japan

  • Tokyo Medical and Dental University

    Tokyo, Bunkyo-ku, 113-8519, Japan

  • Tokyo Yamate Medical Center

    Tokyo, Shinjuku, 169-0073, Japan

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Manitoba - Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • University of Miami

    Miami, Florida, 33136, United States

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Essen AöR

    Essen, 45147, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Victoria Hospital (LHSC)

    London, Ontario, N6A 5W9, Canada

  • Whiston Hospital

    Prescot, L35 5DR, United Kingdom

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

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