BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03648541

Collaborator

(none)

Enrollment

Locations

Arm

102.6

Anticipated Duration (Months)

2.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Spesolimab IV infusion Drug: Spesolimab SC solution for injection	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label, Long Term Safety Trial of BI 65513 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

Actual Study Start Date :

Oct 29, 2018

Anticipated Primary Completion Date :

May 18, 2027

Anticipated Study Completion Date :

May 18, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Patients 1 arm solution for injection Spesolimab will be used for all patients. Those who did not respond to previous induction treatment or experienced disease flare will need i.v. re-induction treatment also	Drug: Spesolimab IV infusion Solution for infusion Drug: Spesolimab SC solution for injection Solution for injection

Arm

Intervention/Treatment

Experimental: All Patients

1 arm solution for injection Spesolimab will be used for all patients. Those who did not respond to previous induction treatment or experienced disease flare will need i.v. re-induction treatment also

Drug: Spesolimab IV infusion

Solution for infusion

Drug: Spesolimab SC solution for injection

Solution for injection

Outcome Measures

Primary Outcome Measures

The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [Up to week 336]

Secondary Outcome Measures

Proportion of patients with clinical remission [Up to 336 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Center of Connecticut, LLC	Hamden	Connecticut	United States	06518
2	Emory University	Atlanta	Georgia	United States	30322
3	University of Chicago	Chicago	Illinois	United States	60637
4	Columbia University Medical Center-New York Presbyterian Hospital	New York	New York	United States	10032
5	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma	United States	73112
6	Southern Star Research Institute, LLC	San Antonio	Texas	United States	78229
7	Texas Digestive Disease Consultants - Southlake	Southlake	Texas	United States	76092
8	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia	United States	23249
9	Ordensklinikum Linz GmbH - Barmherzige Schwestern	Linz		Austria	4010
10	AKH - Medical University of Vienna	Wien		Austria	1090
11	UZ Leuven	Leuven		Belgium	3000
12	Centre Hospitalier Universitaire de Liège	Liège		Belgium	4000
13	Victoria Hospital (LHSC)	London	Ontario	Canada	N6A 5W9
14	Universitätsklinikum Erlangen	Erlangen		Germany	91054
15	Klinikum Esslingen GmbH	Esslingen		Germany	73730
16	Asklepios Kliniken Westklinikum Hamburg	Hamburg		Germany	22559
17	Medizinische Hochschule Hannover	Hannover		Germany	30625
18	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel		Germany	24105
19	Universitätsklinikum Ulm	Ulm		Germany	89081
20	Azienda Ospedaliera Universitaria di Padova	Padova		Italy	35128
21	Istituto Clinico Humanitas	Rozzano (MI)		Italy	20089
22	Sapporo Tokushukai Hospital	Hokkaido, Sapporo		Japan	004-0041
23	Sapporo Higashi Tokushukai Hospital	Hokkaido, Sapporo		Japan	065-0033
24	Hyogo College of Medicine Hospital	Hyogo, Nishinomiya		Japan	663-8501
25	Ofuna Chuo Hospital	Kanagawa, Kamakura		Japan	247-0056
26	Tokyo Medical and Dental University Hospital	Tokyo, Bunkyo-ku		Japan	113-8519
27	Tokyo Yamate Medical Center	Tokyo, Shinjuku		Japan	169-0073
28	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	48108
29	Yeungnam University Medical Center	Daegu		Korea, Republic of	42415
30	Central Clinical Hospital MSWiA, Internal Diseases, Warsaw	Warsaw		Poland	02-507
31	FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.	Irkutsk		Russian Federation	664033
32	Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia	Moscow		Russian Federation	123423
33	Military Medical Academy n.a. C. M. Kirov, St. Petersburg	St. Petersburg		Russian Federation	194044
34	Hospital Virgen del Rocío	Sevilla		Spain	41013
35	Hospital Politècnic La Fe	Valencia		Spain	46026
36	Doncaster Royal Infirmary	Doncaster		United Kingdom	DN2 5LT
37	Guy's Hospital	London		United Kingdom	SE1 9RT
38	Whiston Hospital	Prescot		United Kingdom	L35 5DR

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03648541

Other Study ID Numbers:

1368-0017
2018-000334-35

First Posted:

Aug 27, 2018

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Aug 10, 2022