Clinical trial NCT03648541: BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
Official title: An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Have experienced study treatment-limiting adverse events during induction treatment with study drug
* Have developed any of the exclusion criteria from the original induction study with the following exceptions:

  * 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

Primary outcomes:
measure: Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)
timeFrame: From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.
Secondary outcomes:
measure: Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment
timeFrame: Up to 336 weeks
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
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: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
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: Wien
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: London
country: Canada
facility: Victoria Hospital (LHSC)
state: Ontario
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Hamburg
country: Germany
facility: Asklepios Kliniken Westklinikum Hamburg
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: 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: Kanagawa, Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University 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: National Medical Institute MSWiA
city: Irkutsk
country: Russian Federation
facility: FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
city: St. Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. C. M. Kirov, St. Petersburg
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
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: