Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
2017-004230-28
Query!
Secondary ID [2]
0
0
1368-0005
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of Patients With Clinical Remission at Week 12
Query!
Assessment method [1]
0
0
Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) = 2, with Stool Frequency Score (SFS) = 0 or 1 [if drop =1 from baseline] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) = 1) at week 12.
Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.
Query!
Timepoint [1]
0
0
At week 12.
Query!
Secondary outcome [1]
0
0
Proportion of Patients With Clinical Response at Week 12
Query!
Assessment method [1]
0
0
Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) = 1 or decrease by =1 from baseline; and total Mayo Clinical Score (MCS) decrease by = 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.
Query!
Timepoint [1]
0
0
At week 12.
Query!
Secondary outcome [2]
0
0
Proportion of Patients With Endoscopic Improvement at Week 12
Query!
Assessment method [2]
0
0
Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) = 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.
Query!
Timepoint [2]
0
0
At week 12.
Query!
Secondary outcome [3]
0
0
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12
Query!
Assessment method [3]
0
0
Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) = 1 and Robarts Histology Index = 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.
Query!
Timepoint [3]
0
0
At week 12.
Query!
Secondary outcome [4]
0
0
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12
Query!
Assessment method [4]
0
0
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12.
The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID).
Mean is adjusted mean.
Query!
Timepoint [4]
0
0
At baseline and at week 12.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/03/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/05/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
98
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Oklahoma
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Virginia
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Linz
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Vienna
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Leuven
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Liège
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Manitoba
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Aachen
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Erlangen
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Essen
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Esslingen
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Hannover
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Kiel
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Ulm
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Padova
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Rozzano (MI)
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Chiba, Sakura
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Hokkaido, Sapporo
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Hyogo, Nishinomiya
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Kagoshima, Kagoshima
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Kanagawa, Kamakura
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Tokyo, Bunkyo-ku
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Tokyo, Minato-ku
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Tokyo, Shinjuku
Query!
Country [33]
0
0
Korea, Republic of
Query!
State/province [33]
0
0
Busan
Query!
Country [34]
0
0
Korea, Republic of
Query!
State/province [34]
0
0
Daegu
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Warsaw
Query!
Country [36]
0
0
Russian Federation
Query!
State/province [36]
0
0
Irkutsk
Query!
Country [37]
0
0
Russian Federation
Query!
State/province [37]
0
0
Kirov
Query!
Country [38]
0
0
Russian Federation
Query!
State/province [38]
0
0
Moscow
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Pyatigorsk
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Saint-Petersburg
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
Sevilla
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Valencia
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Barnsley
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Doncaster
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
London
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Prescot
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03482635
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03482635
Download to PDF