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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05528510




Registration number
NCT05528510
Ethics application status
Date submitted
19/08/2022
Date registered
6/09/2022

Titles & IDs
Public title
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2022-000365-41
Secondary ID [2] 0 0
CR109228
Universal Trial Number (UTN)
Trial acronym
ASTRO
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 - Guselkumab Dose 1
Treatment: Drugs - Guselkumab Dose 2
Treatment: Drugs - Guselkumab Dose 3
Other interventions - Placebo

Experimental: Group 1: Guselkumab - Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Experimental: Group 2: Guselkumab - Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Placebo comparator: Group 3: Placebo - Participants will receive matching placebo SC injection.


Treatment: Drugs: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.

Treatment: Drugs: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered as SC injection.

Treatment: Drugs: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered as SC injection.

Other interventions: Placebo
Placebo will be administered as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Symptomatic Remission
Timepoint [1] 0 0
Weeks 12 and 24
Secondary outcome [2] 0 0
Endoscopic Improvement
Timepoint [2] 0 0
Weeks 12 and 24
Secondary outcome [3] 0 0
Clinical Response
Timepoint [3] 0 0
Weeks 12 and 24
Secondary outcome [4] 0 0
Clinical Remission
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Histologic-Endoscopic Mucosal Improvement
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
Timepoint [6] 0 0
Up to Week 268

Eligibility
Key inclusion criteria
* Signed informed consent form
* 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined 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
* Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
* Receiving prohibited medications and treatments
* UC limited to the rectum only
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

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 3
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
13/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/10/2028
Actual
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
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Royal Prince Alfred Hospital - Camperdown
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Monash Health - Clayton
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Royal Brisbane and Women's Hospital - Herston
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Fiona Stanley Hospital - Murdoch
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Royal Melbourne Hospital - Parkville
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IBD Clinical Trials Mater Research - South Brisbane
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The Queen Elizabeth Hospital - Woodville South
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Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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4029 - Herston
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6150 - Murdoch
Recruitment postcode(s) [6] 0 0
3050 - Parkville
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4101 - South Brisbane
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5011 - Woodville South
Recruitment postcode(s) [9] 0 0
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/NCT05528510