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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04033445




Registration number
NCT04033445
Ethics application status
Date submitted
24/07/2019
Date registered
26/07/2019

Titles & IDs
Public title
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2018-004002-25
Secondary ID [2] 0 0
CR108657
Universal Trial Number (UTN)
Trial acronym
QUASAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 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 - Placebo
Treatment: Drugs - Guselkumab

Experimental: Induction Study 1: Guselkumab Dose 1 - Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Experimental: Induction Study 1: Guselkumab Dose 2 - Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Placebo comparator: Induction Study 1: Placebo IV - Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Experimental: Induction Study 2: Guselkumab IV - Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Placebo comparator: Induction Study 2: Placebo IV - Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Experimental: Maintenance Study: Maintenance Dose Regimen 1 - Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Experimental: Maintenance Study: Maintenance Dose Regimen 2 - Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Placebo comparator: Maintenance Study: Placebo SC - Participants will receive matching placebo SC q4w.


Treatment: Drugs: Placebo
Participants will receive matching placebo IV or SC.

Treatment: Drugs: Guselkumab
Participants will receive guselkumab IV or SC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study 1: Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Induction Study 2: Clinical Remission at Week 12
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Maintenance Study: Clinical Remission at Week 44
Timepoint [3] 0 0
Week 44
Secondary outcome [1] 0 0
Induction Study 1: Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Induction Study 1: Symptomatic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Induction Study 1: Endoscopic Healing at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Induction Study 1: Endoscopic Normalization at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Induction Study 2: Symptomatic Remission at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Induction Study 2: Endoscopic Healing at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Induction Study 2: Clinical Response at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Induction Study 2: Symptomatic Remission at Week 4
Timepoint [9] 0 0
Week 4
Secondary outcome [10] 0 0
Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Induction Study 2: Fatigue Response at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Induction Study 2: Symptomatic Remission at Week 2
Timepoint [13] 0 0
Week 2
Secondary outcome [14] 0 0
Induction Study 2: Endoscopic Normalization at Week 12
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Maintenance Study: Symptomatic Remission at Week 44
Timepoint [15] 0 0
Week 44
Secondary outcome [16] 0 0
Maintenance Study: Endoscopic Healing at Week 44
Timepoint [16] 0 0
Week 44
Secondary outcome [17] 0 0
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44
Timepoint [17] 0 0
Week 44
Secondary outcome [18] 0 0
Maintenance Study: Clinical Response at Week 44
Timepoint [18] 0 0
Week 44
Secondary outcome [19] 0 0
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44
Timepoint [19] 0 0
Week 44
Secondary outcome [20] 0 0
Maintenance Study: IBDQ Remission at Week 44
Timepoint [20] 0 0
Week 44
Secondary outcome [21] 0 0
Maintenance Study: Fatigue Response at Week 44
Timepoint [21] 0 0
Week 44
Secondary outcome [22] 0 0
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline
Timepoint [22] 0 0
Week 44
Secondary outcome [23] 0 0
Maintenance Study: Endoscopic Normalization at Week 44
Timepoint [23] 0 0
Week 44

Eligibility
Key inclusion criteria
* Documented diagnosis of ulcerative colitis (UC)
* Moderately to severely active UC, defined by modified Mayo score
* Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
* Screening laboratory test results within the parameters specified in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
* UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
* Presence of a stoma
* Presence or history of a fistula
* Receiving prohibited medications and/or treatment

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2027
Actual
Sample size
Target
Accrual to date
Final
1064
Recruitment in Australia
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Emeritus Research - Camberwell
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Monash Health - Clayton
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Western Health - Footscray
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Fiona Stanley Hospital - Murdoch
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Royal Perth Hospital - Perth
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Mater Hospital - South Brisbane
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St John of God Subiaco Hospital - Subiaco
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Princess Alexandra Hospital - Woolloongabba
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3124 - Camberwell
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3156 - Clayton
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3011 - Footscray
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6150 - Murdoch
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6000 - Perth
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4101 - South Brisbane
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6008 - Subiaco
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4102 - Woolloongabba
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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 not provided in https://clinicaltrials.gov/study/NCT04033445