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

Colitis, Ulcerative Clinical Trial

Official title:

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482635
• Other study ID #: 1368-0005
• Secondary ID: 2017-004230-28
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 27, 2018
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 TNF? antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNF? 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Spesolimab
Solution for infusion
• Placebo
Solution for infusion

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH - Barmherzige Schwestern	Linz
Austria	AKH - Medical University of Vienna	Vienna
Belgium	UZ Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Canada	Victoria Hospital (LHSC)	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University of Manitoba - Health Sciences Centre	Winnipeg	Manitoba
Germany	Universitätsklinikum Aachen, AöR	Aachen
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Essen AöR	Essen
Germany	Klinikum Esslingen GmbH	Esslingen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universitätsklinikum Ulm	Ulm
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Japan	Toho University Sakura Medical Center	Chiba, Sakura
Japan	Sapporo Higashi Tokushukai Hospital	Hokkaido, Sapporo
Japan	Sapporo Tokushukai Hospital	Hokkaido, Sapporo
Japan	Hyogo College of Medicine Hospital	Hyogo, Nishinomiya
Japan	Sameshima Hospital	Kagoshima, Kagoshima
Japan	Ofuna Chuo Hospital	Kanagawa, Kamakura
Japan	Tokyo Medical and Dental University	Tokyo, Bunkyo-ku
Japan	Kitasato Institute Hospital	Tokyo, Minato-ku
Japan	Tokyo Yamate Medical Center	Tokyo, Shinjuku
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Poland	Central Clinical Hospital MSWiA, Internal Diseases, Warsaw	Warsaw
Poland	Health Center of Mother, Child and Youth Sp.z o.o.	Warsaw
Russian Federation	FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.	Irkutsk
Russian Federation	Kirov State Med.Univ. of MoH RF	Kirov
Russian Federation	Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia	Moscow
Russian Federation	Reg. Clin. Scientific Research Institute na Vladimiskiy	Moscow
Russian Federation	The limited liability company "Clinic USI 4D"	Pyatigorsk
Russian Federation	FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"	Saint-Petersburg
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Politècnic La Fe	Valencia
United Kingdom	Barnsley Hospital	Barnsley
United Kingdom	Doncaster Royal Infirmary	Doncaster
United Kingdom	Guy's Hospital	London
United Kingdom	Whiston Hospital	Prescot
United States	Emory University	Atlanta	Georgia
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	University of Miami	Miami	Florida
United States	Columbia University Medical Center-New York Presbyterian Hospital	New York	New York
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Patients With Clinical Response at Week 12	Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) = 1 or decrease by =1 from baseline; and total Mayo Clinical Score (MCS) decrease by = 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.	At week 12.
Secondary	Proportion of Patients With Endoscopic Improvement at Week 12	Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) = 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.	At week 12.
Secondary	Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12	Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) = 1 and Robarts Histology Index = 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.	At week 12.
Secondary	Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12	Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12.; The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID).; Mean is adjusted mean.	At baseline and at week 12.

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