BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

NCT03648541 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00172018-000334-35
• Study Type: interventional
• Target: 79
• Locations: 12 countries
• Sites: 38

Brief Summary

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)

  Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE). The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years). Only participants receiving maintenance treatment were analysed for this endpoint.

  From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.

Secondary Outcomes (1)

• Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment

  Up to 336 weeks

Study Arms (2)

Spesolimab IV infusion

EXPERIMENTAL

Spesolimab IV infusion

Drug: Spesolimab

Spesolimab SC solution for injection

EXPERIMENTAL

Spesolimab SC solution for injection

Drug: Spesolimab

Interventions

Spesolimab DRUG

Solution

Spesolimab IV infusion; Spesolimab SC solution for injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have experienced study treatment-limiting adverse events during induction treatment with study drug
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (38)

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, 4010, Austria

Location

AKH - Medical University of Vienna

Vienna, 1090, Austria

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Victoria Hospital (LHSC)

London, Ontario, N6A 5W9, Canada

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730, Germany

Location

Asklepios Kliniken Westklinikum Hamburg

Hamburg, 22559, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

Sapporo Tokushukai Hospital

Hokkaido, Sapporo, 004-0041, Japan

Location

Sapporo Higashi Tokushukai Hospital

Hokkaido, Sapporo, 065-0033, Japan

Location

Hyogo College of Medicine Hospital

Hyogo, Nishinomiya, 663-8501, Japan

Location

Ofuna Chuo Hospital

Kanagawa, Kamakura, 247-0056, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, Bunkyo-ku, 113-8519, Japan

Location

Tokyo Yamate Medical Center

Tokyo, Shinjuku, 169-0073, Japan

Location

National Medical Institute MSWiA

Warsaw, 02-507, Poland

Location

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

Irkutsk, 664033, Russia

Location

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

Moscow, 123423, Russia

Location

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

Saint Petersburg, 194044, Russia

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Politècnic La Fe

Valencia, 46026, Spain

Location

Doncaster Royal Infirmary

Doncaster, DN2 5LT, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Whiston Hospital

Prescot, L35 5DR, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

This trial was prematurely ended due to the decision to discontinue the clinical development of spesolimab in inflammatory bowel disease. This decision was based on a lower-than-expected efficacy in previous clinical trials conducted in ulcerative colitis and fistulising Crohn's disease. The decision was not related to any safety findings. The trial was completed as described in the protocol.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

18002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 27, 2018
• Study Start: October 29, 2018
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: October 20, 2025
• Results First Posted: July 3, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); ES (2); JP (6); KR (2); IT (2); PL (1); US (8); RU (3); GB (3); CA (1); AU (2); BE (2)