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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab
Treatment: Drugs - Placebo

Experimental: Group 1- Placebo Group -

Experimental: Group 2- Small Dose Group -

Experimental: Group 3- Medium Dose Group -

Experimental: Group 4 - High Dose Group -


Treatment: Drugs: Spesolimab
Solution for infusion

Treatment: Drugs: Placebo
Solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients With Clinical Remission at Week 12
Timepoint [1] 0 0
At week 12.
Secondary outcome [1] 0 0
Proportion of Patients With Clinical Response at Week 12
Timepoint [1] 0 0
At week 12.
Secondary outcome [2] 0 0
Proportion of Patients With Endoscopic Improvement at Week 12
Timepoint [2] 0 0
At week 12.
Secondary outcome [3] 0 0
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
Timepoint [3] 0 0
At week 12.
Secondary outcome [4] 0 0
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
Timepoint [4] 0 0
At baseline and at week 12.

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/Phase 3
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Linz
Country [11] 0 0
Austria
State/province [11] 0 0
Vienna
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Germany
State/province [16] 0 0
Aachen
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Esslingen
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Kiel
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Italy
State/province [23] 0 0
Padova
Country [24] 0 0
Italy
State/province [24] 0 0
Rozzano (MI)
Country [25] 0 0
Japan
State/province [25] 0 0
Chiba, Sakura
Country [26] 0 0
Japan
State/province [26] 0 0
Hokkaido, Sapporo
Country [27] 0 0
Japan
State/province [27] 0 0
Hyogo, Nishinomiya
Country [28] 0 0
Japan
State/province [28] 0 0
Kagoshima, Kagoshima
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa, Kamakura
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo, Bunkyo-ku
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo, Minato-ku
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo, Shinjuku
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Busan
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Daegu
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Irkutsk
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Kirov
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Pyatigorsk
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Saint-Petersburg
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Spain
State/province [42] 0 0
Valencia
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Barnsley
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Doncaster
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Prescot

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03482635
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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