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New drug shows promise for Long-Term ulcerative colitis control

NCT ID NCT03648541

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the long-term safety of a drug called spesolimab in adults with moderate to severe ulcerative colitis who had already finished earlier trials. Researchers tracked side effects and checked if patients achieved remission over about 6.5 years. The goal was to see if the drug remains safe and effective for ongoing disease management.

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

79 people

The number who actually took part.

Started

Oct 2018

Finished

May 2023

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 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: * Male or female patients, aged ≥18 years * Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial * Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17. Exclusion Criteria: * Have experienced study treatment-limiting adverse events during induction treatment with study drug * Have developed any of the exclusion criteria from the original induction study with the following exceptions: * Cases of disease limited to the rectum extending \<15 cm past the anal verge are allowed to be included in study 1368.17 * Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines

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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

  • Asklepios Kliniken Westklinikum Hamburg

    Hamburg, 22559, Germany

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • 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, 664033, Russia

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

    Moscow, 123423, Russia

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • 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

  • 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

  • Military Medical Academy n.a. C. M. Kirov, St. Petersburg

    Saint Petersburg, 194044, Russia

  • National Medical Institute MSWiA

    Warsaw, 02-507, Poland

  • Ofuna Chuo Hospital

    Kanagawa, Kamakura, 247-0056, Japan

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, 4010, Austria

  • 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

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092, United States

  • Tokyo Medical and Dental University Hospital

    Tokyo, Bunkyo-ku, 113-8519, Japan

  • Tokyo Yamate Medical Center

    Tokyo, Shinjuku, 169-0073, Japan

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Universitätsklinikum Erlangen

    Erlangen, 91054, 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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