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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Research Center of Connecticut, LLC
  • University of Miami
  • AdventHealth Orlando
  • Emory University
  • Atlanta Center for Gastroenterology, P.C.
  • University of Chicago
  • Columbia University Medical Center-New York Presbyterian Hospital
  • University Hospitals of Cleveland
  • Digestive Disease Specialists Inc
  • Baylor College of Medicine
  • Southern Star Research Institute, LLC
  • Texas Digestive Disease Consultants - Southlake
  • Hunter Holmes McGuire VA Medical Center
  • Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • AKH - Medical University of Vienna
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • University of Manitoba - Health Sciences Centre
  • Victoria Hospital (LHSC)
  • Sunnybrook Health Sciences Centre
  • Universitätsklinikum Aachen, AöR
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen AöR
  • Klinikum Esslingen GmbH
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Universitätsklinikum Ulm
  • Azienda Ospedaliera Universitaria di Padova
  • Istituto Clinico Humanitas
  • Toho University Sakura Medical Center
  • Sapporo Tokushukai Hospital
  • Sapporo Higashi Tokushukai Hospital
  • Hyogo College of Medicine Hospital
  • Sameshima Hospital
  • Ofuna Chuo Hospital
  • Tokyo Medical and Dental University
  • Kitasato Institute Hospital
  • Tokyo Yamate Medical Center
  • Inje University Haeundae Paik Hospital
  • Yeungnam University Medical Center
  • Health Center of Mother, Child and Youth Sp.z o.o.
  • Central Clinical Hospital MSWiA, Internal Diseases, Warsaw
  • FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
  • Kirov State Med.Univ. of MoH RF
  • Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
  • Reg. Clin. Scientific Research Institute na Vladimiskiy
  • The limited liability company "Clinic USI 4D"
  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"
  • Hospital Virgen del Rocío
  • Hospital Politècnic La Fe
  • Barnsley Hospital
  • Doncaster Royal Infirmary
  • Guy's Hospital
  • Whiston Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1- Placebo Group

Group 2- Small Dose Group

Group 3- Medium Dose Group

Group 4 - High Dose Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 15, 2018
Last Updated
May 18, 2021
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT03482635
Brief Title
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1- Placebo Group
Arm Type
Experimental
Arm Title
Group 2- Small Dose Group
Arm Type
Experimental
Arm Title
Group 3- Medium Dose Group
Arm Type
Experimental
Arm Title
Group 4 - High Dose Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Solution for infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Proportion of Patients With Clinical Remission at Week 12
Description
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.
Time Frame
At week 12.
Secondary Outcome Measure Information:
Title
Proportion of Patients With Clinical Response at Week 12
Description
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.
Time Frame
At week 12.
Title
Proportion of Patients With Endoscopic Improvement at Week 12
Description
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.
Time Frame
At week 12.
Title
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
Description
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.
Time Frame
At week 12.
Title
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
Description
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.
Time Frame
At baseline and at week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Columbia University Medical Center-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Digestive Disease Specialists Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Ordensklinikum Linz GmbH - Barmherzige Schwestern
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
AKH - Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Manitoba - Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Victoria Hospital (LHSC)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Universitätsklinikum Aachen, AöR
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen AöR
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Toho University Sakura Medical Center
City
Chiba, Sakura
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Sapporo Tokushukai Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Hyogo, Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima, Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Ofuna Chuo Hospital
City
Kanagawa, Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Tokyo Medical and Dental University
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Kitasato Institute Hospital
City
Tokyo, Minato-ku
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Tokyo Yamate Medical Center
City
Tokyo, Shinjuku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Health Center of Mother, Child and Youth Sp.z o.o.
City
Warsaw
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Central Clinical Hospital MSWiA, Internal Diseases, Warsaw
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation
Facility Name
Kirov State Med.Univ. of MoH RF
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Reg. Clin. Scientific Research Institute na Vladimiskiy
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
The limited liability company "Clinic USI 4D"
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Barnsley Hospital
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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

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