A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2019-001673-93-AT
• Date of registration: 13/12/2019
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.
• Scientific title: An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials
• Date of first enrolment: 05/02/2020
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001673-93
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Denmark, Germany, Hungary, Korea, Republic of, Netherlands, Spain

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
- Patient older than 18 years
- Has completed all treatments (placebo or active treatment) and the EOT visit in the parent induction trial in fistulising CD and is willing and able to continue treatment in 1368-0007.
- Has obtained an individual health benefit, per investigator judgement (such as fistula response or remission or other clinical improvement), from treatment in the parent trial.
- Signed and dated written informed consent for 1368-0007 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
- Have experienced treatment-limiting adverse events during induction treatment with study drug.
- Have developed any condition which meets the exclusion criteria from the original induction study.
- Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohns disease
MedDRA version: 20.0 Level: LLT Classification code 10011408 Term: Crohns disease aggravated System Organ Class: 100000004856

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Code: BI 655130
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Spesolimab
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Primary end point(s): 1) Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)

Timepoint(s) of evaluation of this end point: 1) Up to week 336

Main Objective: To evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn’s disease who have completed treatment in parent trials

Secondary Objective: To evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn’s disease, who have completed treatment in parent trials

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Weeks 48, 96, 144, 192, 240, 288, and 336
2) Week 48, 96, 144, 192, 240, 288, and 336

Secondary end point(s): 1) Proportion of patients with perianal fistula remission
2) Proportion of patients with perianal fistula response

Secondary ID(s)

1368-0007

Source(s) of Monetary Support

Boehringer-Ingelheim Pharma GmbH & Co.KG

Ethics review

Status: Approved
Approval date: 05/02/2020
Contact: