Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03482635




Registration number
NCT03482635
Ethics application status
Date submitted
15/03/2018
Date registered
29/03/2018
Date last updated
11/06/2021

Titles & IDs
Public title
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
2017-004230-28
Secondary ID [2] 0 0
1368-0005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Group 1- Placebo Group -

Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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 TNF? antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNF? 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2020
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03482635