Clinical trial NCT03482635: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colitis, Ulcerative
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Patients With Clinical Remission at Week 12
timeFrame: At week 12.
Secondary outcomes:
measure: Proportion of Patients With Clinical Response at Week 12
timeFrame: At week 12.
measure: Proportion of Patients With Endoscopic Improvement at Week 12
timeFrame: At week 12.
measure: Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
timeFrame: At week 12.
measure: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
timeFrame: At baseline and at week 12.
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Winnipeg
country: Canada
facility: University of Manitoba - Health Sciences Centre
state: Manitoba
city: London
country: Canada
facility: Victoria Hospital (LHSC)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen AöR
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Chiba, Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Hyogo, Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
city: Kagoshima, Kagoshima
country: Japan
facility: Sameshima Hospital
city: Kanagawa, Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo, Minato-ku
country: Japan
facility: Kitasato Institute Hospital
city: Tokyo, Shinjuku
country: Japan
facility: Tokyo Yamate Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Warsaw
country: Poland
facility: Health Center of Mother, Child and Youth Sp.z o.o.
city: Warsaw
country: Poland
facility: Central Clinical Hospital MSWiA, Internal Diseases, Warsaw
city: Irkutsk
country: Russian Federation
facility: FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
city: Kirov
country: Russian Federation
facility: Kirov State Med.Univ. of MoH RF
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
city: Moscow
country: Russian Federation
facility: Reg. Clin. Scientific Research Institute na Vladimiskiy
city: Pyatigorsk
country: Russian Federation
facility: The limited liability company "Clinic USI 4D"
city: Saint-Petersburg
country: Russian Federation
facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: London
country: United Kingdom
facility: Guy's Hospital
city: Prescot
country: United Kingdom
facility: Whiston Hospital
Study officials:
References: