Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001144303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
8/07/2026
Date registered
Help: Date registered
15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Crohn's Disease Stricture Treatment by Reduction of IL-23 with Guselkumab Versus Optimise Existing Medical Therapy Combined with Endoscopic Dilation (STRIVE) Randomised Controlled Trial
Scientific title
Stricture Treatment by Reduction of IL-23 with Guselkumab Versus Optimise Existing Medical Therapy Combined with Endoscopic Dilation: Assessing Impact on Crohn’s Disease Stricture Resolution
Additional trial identifiers [1] 317847 0
Nil
Universal Trial Number (UTN)
Trial acronym
STRIVE
Related trial records

Health condition
Health condition(s) studied:
Crohn's disease stricture 342779 0
Condition category
Condition code
Inflammatory and Immune System 338908 338908 0 0
Autoimmune diseases
Oral and Gastrointestinal 338909 338909 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants in the guselkumab arm will be given guselkumab 400mg subcutaneously at week 0, 4 and 8, followed by 200mg at week 12 and every four weeks thereafter. In countries that do not permit 200mg 4 weekly subcutaneous dosing, participants will commence at 100mg subcutaneously at week 12 and every eight weeks thereafter; they will be allowed to be dose escalated if they are non-responsive on IUS.
The participant will self-administer the intervention.
Participants will be verbally asked regarding their adherence to the study medication.
There is no pre-defined maximum duration of administration; the trial will go for 100 weeks and participants will return to the care of their gastroenterologist thereafter. Ongoing medication will depend on the patient's clinical status and will be at the discretion of the treating gastroenterologist.
Intervention code [1] 334685 0
Treatment: Drugs
Description of the comparator or control
Participants in the control arm will have their existing medical therapy optimised (e.g. commencing immunomodulator, drug dose escalation of immunomodulator by therapeutic drug monitoring, ensure medication adherence, use of short-term steroids with enforced tapering). This will be at the discretion of the treating gastroenterologist. Participants will be reviewed at week 0, 4, 8, 12, 24, 36, 52, 76 and 100.
Control group
Active

Outcomes
Primary outcome [1] 346123 0
Complete endoscopic resolution of all strictures
Timepoint [1] 346123 0
Week 52 post-enrolment
Secondary outcome [1] 464679 0
MRI stricture response
Timepoint [1] 464679 0
Week 52 and 100 52 post-enrolment
Secondary outcome [2] 464680 0
Intestinal ultrasound (IUS) stricture response is defined as reduction in stricture length, improvement of >25% in bowel wall thickness, improvement of >50% in luminal narrowing, either reduction in the absolute diameter of more than 25% or a bowel diameter of less <2.5 cm
Timepoint [2] 464680 0
Week 12, 24, 52, 76 and 100 post-enrolment
Secondary outcome [3] 464681 0
MRI stricture resolution
Timepoint [3] 464681 0
Week 52 and 100 post-enrolment
Secondary outcome [4] 464682 0
Intestinal ultrasound stricture resolution
Timepoint [4] 464682 0
week 12, 24, 52, 76 and 100 post-enrolment
Secondary outcome [5] 464683 0
Need for surgical intervention
Timepoint [5] 464683 0
Week 52 and 100 post-enrolment
Secondary outcome [6] 464684 0
Treatment failure
Timepoint [6] 464684 0
Week 52 post-enrolment
Secondary outcome [7] 467513 0
Need for additional endoscopic intervention (breeching dilatation protocol)
Timepoint [7] 467513 0
Week 52 and 100 post-enrolment
Secondary outcome [8] 467515 0
Quality of life
Timepoint [8] 467515 0
Week 24, 52, 76 and 100 post-enrolment
Secondary outcome [9] 467516 0
Work productivity
Timepoint [9] 467516 0
Week 24, 52, 76 and 100 post-enrolment
Secondary outcome [10] 467517 0
Health-related quality of life
Timepoint [10] 467517 0
Week 24, 52, 76 and 100 post-enrolment
Secondary outcome [11] 467518 0
Fatigue
Timepoint [11] 467518 0
Week 24, 52, 76 and 100 post-enrolment
Secondary outcome [12] 467519 0
Food related quality of life
Timepoint [12] 467519 0
Week 24, 52, 76 and 100 post-enrolment
Secondary outcome [13] 467520 0
Fear of Food
Timepoint [13] 467520 0
Week 24, 52, 76 and 100 post-enrolment

Eligibility
Key inclusion criteria
• Adult participants aged greater than or equal to 18 years with stricturing Crohn's disease (CD), with all ileal or ileocolic anastomotic strictures accessible with colonoscopy. A stricture will be defined endoscopically, as an narrowing where an adult colonoscope cannot be passed through the narrowed area without prior endoscopic dilation with a reasonable amount of pressure applied
• Asymptomatic or minimally symptomatic participants
• Participants with de novo ileal strictures or post-operative anastomotic strictures
• Participants with single or multiple strictures
• Participants who are eligible for initiation of advanced therapy as per the Pharmaceutical Benefits Scheme criteria or equivalent criteria in that country.
• Participants must be on stable doses of medical therapy for at least 6 months prior to study enrolment.
• Participants with previous or current treatment with any non-p19 biologics
• No more than 30% of participants will have previously failed more than one advanced therapy.
• Contraceptive use for the study duration for female participants of childbearing potential
• Willingness to provide informed consent and follow the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Participants who have previously been treated with guselkumab or any other p19 inhibitor
• Contraindication to guselkumab
• Uncontrolled sepsis
• Acute overt bowel obstruction not responding to conservative treatment with nasogastric suction, intravenous fluids, bowel rest, and systemic corticosteroids
• Participants who are deemed to require urgent surgical intervention
• Duodenal, colonic, anal or rectal strictures, proximal small bowel strictures not accessible via colonoscope
• Irresectable dysplasia or active malignancy (except for non-melanomatous skin cancer)
• Pregnancy or planning a pregnancy in the next two years
• Breast feeding
• Conditions interfering with treatment adherence
• Individuals with a condition which may interfere with their ability to understand the study requirements
• Participants who cannot read or understand the Participant Information and Consent Form and provide consent themselves.

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)
Participants will be randomised 2:1 to either the guselkumab arm or the control arm. Randomisation will be performed using the randomisation module on the REDCap platform
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, using computer-generated permuted blocks of randomly varying sizes of 6 and 9.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 28308 0
Taiwan, Province Of China
State/province [1] 28308 0
Country [2] 28309 0
China
State/province [2] 28309 0
Country [3] 28310 0
Hong Kong
State/province [3] 28310 0
Country [4] 28311 0
Korea, Republic Of
State/province [4] 28311 0

Funding & Sponsors
Funding source category [1] 322388 0
Commercial sector/Industry
Name [1] 322388 0
Johnson and Johnson
Country [1] 322388 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325311 0
None
Name [1] 325311 0
None
Address [1] 325311 0
Country [1] 325311 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320889 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 320889 0
Ethics committee country [1] 320889 0
Australia
Date submitted for ethics approval [1] 320889 0
29/06/2026
Approval date [1] 320889 0
Ethics approval number [1] 320889 0

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

Contacts
Principal investigator
Name 151970 0
Prof Rupert W. Leong
Address 151970 0
Concord Repatriation General Hospital, 1 West ACE Unit, Hospital Road Concord NSW 2139
Country 151970 0
Australia
Phone 151970 0
+61 2 9767 5563
Fax 151970 0
Email 151970 0
[email protected]
Contact person for public queries
Name 151971 0
Dr Bonita Gu
Address 151971 0
Concord Repatriation General Hospital, 1 West ACE Unit, Hospital Road Concord NSW 2139
Country 151971 0
Australia
Phone 151971 0
+61 2 9767 6111
Fax 151971 0
Email 151971 0
[email protected]
Contact person for scientific queries
Name 151972 0
Dr Bonita Gu
Address 151972 0
Concord Repatriation General Hospital, 1 West ACE Unit, Hospital Road Concord NSW 2139
Country 151972 0
Australia
Phone 151972 0
+61 2 9767 6111
Fax 151972 0
Email 151972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.