None listed
Conditions
Brief summary
This study aims to determine whether guselkumab is more effective than optimising current medical treatment for adults with stricturing Crohn's disease. Participants will be randomly assigned to receive either guselkumab or optimise their existing advanced medical therapy. We will compare how well these treatments improve bowel strictures, reduce the need for surgery, and improve symptoms and quality of life. We expect that guselkumab will be more effective at treating bowel strictures and slowing disease progression. This is the first randomised controlled trial specifically designed for people with stricturing Crohn's disease, a group that has largely been excluded from previous clinical trials.
Interventions
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 rega
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.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed