BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

NCT03482635 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00052017-004230-28
• Study Type: interventional
• Target: 98
• Locations: 12 countries
• Sites: 54

Brief Summary

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

• to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
• to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
• To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Clinical Remission at Week 12

  Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \[if drop ≥1 from baseline\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.

  At week 12.

Secondary Outcomes (4)

• Proportion of Patients With Clinical Response at Week 12

  At week 12.

• Proportion of Patients With Endoscopic Improvement at Week 12

  At week 12.

• Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12

  At week 12.

• Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12

  At baseline and at week 12.

Study Arms (4)

Group 1- Placebo Group

EXPERIMENTAL

Drug: Placebo

Group 2- Small Dose Group

EXPERIMENTAL

Drug: Spesolimab

Group 3- Medium Dose Group

EXPERIMENTAL

Drug: Spesolimab

Group 4 - High Dose Group

EXPERIMENTAL

Drug: Spesolimab

Interventions

Spesolimab DRUG

Solution for infusion

Group 2- Small Dose Group; Group 3- Medium Dose Group; Group 4 - High Dose Group

Placebo DRUG

Solution for infusion

Group 1- Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (54)

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033, 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

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, 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, A-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

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Victoria Hospital (LHSC)

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen AöR

Essen, 45147, Germany

Location

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730, 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

Toho University Sakura Medical Center

Chiba, Sakura, 285-8741, Japan

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

Sameshima Hospital

Kagoshima, Kagoshima, 892-0846, Japan

Location

Ofuna Chuo Hospital

Kanagawa, Kamakura, 247-0056, Japan

Location

Tokyo Medical and Dental University

Tokyo, Bunkyo-ku, 113-8519, Japan

Location

Kitasato Institute Hospital

Tokyo, Minato-ku, 108-8642, Japan

Location

Tokyo Yamate Medical Center

Tokyo, Shinjuku, 169-0073, Japan

Location

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

Warsaw, 00-632, Poland

Location

Central Clinical Hospital MSWiA, Internal Diseases, Warsaw

Warsaw, 02-507, Poland

Location

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

Irkutsk, 664003, Russia

Location

Kirov State Med.Univ. of MoH RF

Kirov, 610027, Russia

Location

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

Moscow, 123423, Russia

Location

Reg. Clin. Scientific Research Institute na Vladimiskiy

Moscow, 129110, Russia

Location

The limited liability company "Clinic USI 4D"

Pyatigorsk, 357502, Russia

Location

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

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

Barnsley Hospital

Barnsley, S75 2EP, United Kingdom

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 Publications (1)

• Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.

  PMID: 39216969 DERIVED

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

Due to recruitment issues during phase II, the trial was prematurely ended according to a protocol defined option. Phase III was not conducted. The trial was completed as defined in the protocol.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: March 27, 2018
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: October 16, 2025
• Results First Posted: June 11, 2021

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); DE (7); RU (6); CA (3); PL (2); ES (2); GB (4); IT (2); US (13); JP (9); AU (2); BE (2)