Switching to the IL-23 inhibitor guselkumab for people with active inflammatory bowel disease (IBD) who previously used ustekinumab (SHIFT-IBD)

ISRCTN	ISRCTN13202059
DOI	https://doi.org/10.1186/ISRCTN13202059
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	TIDHI_001
Sponsor	TIDHI Innovation Inc.
Funder	Janssen Canada

Submission date: 06/11/2025
Registration date: 07/11/2025
Last edited: 03/12/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The SHIFT-IBD Study is looking at how well a medicine called guselkumab (also known by its brand name Tremfya) works for people with inflammatory bowel disease (IBD) who haven’t had enough improvement with another medicine called ustekinumab. Researchers hope this study will help find better treatment options for people whose IBD is still active despite current therapies.

Who can participate?
Adults aged 18 and over who have had a confirmed diagnosis of IBD (Crohn’s disease, ulcerative colitis, or IBD unclassified) for at least six months may be eligible. Participants must have been treated with ustekinumab for at least 14 weeks and either still be on it or have stopped it recently. They must also have ongoing signs of disease activity seen during a recent colonoscopy and be starting guselkumab based on their doctor’s recommendation.

What does the study involve?
Participants will begin treatment with guselkumab as part of their regular care. Doctors can adjust the treatment as needed. The study will follow participants for one year, monitoring symptoms, test results, and overall health. The goal is to see how well guselkumab works and whether it helps control symptoms without worsening test results.

What are the possible benefits and risks of participating?
Participants may benefit from improved symptom control if guselkumab works better for them than previous treatments. As with any medication, there may be side effects or risks, but guselkumab will be given according to standard medical guidelines, and doctors will monitor participants closely.

Where is the study run from?
TIDHI Innovation Inc. (Canada)

When is the study starting and how long is it expected to run for?
The study began in September 2024 and is expected to run until December 2027.

Who is funding the study?
Janssen Canada.

Who is the main contact?
kstaikin@tidhi.ca

Contact information

Prof Laura Targownik
Scientific, Principal investigator

700 Lawrence Avenue West, Suite 360
Toronto, ON
M6A 3B4
Canada

ORCID ID	0000-0002-4366-9076
Phone	+1 416-586-4800 x 4304
Email	Laura.Targownik@sinaihealth.ca

Dr Mark Silverberg
Scientific, Principal investigator

700 Lawrence Avenue West, Suite 360
Toronto, ON
M6A 3B4
Canada

Phone	+1 647-812-2113
Email	msilverberg@tidhi.ca

Ms Ajani Jeyakumar
Public

700 Lawrence Ave. W, Suite 360
Toronto, ON
M6A 3B4
Canada

Phone	+1 647-812-2113
Email	ajeyakumar@tidhi.ca

Mrs Katy Staikin
Public

700 Lawrence Ave. W, Suite 360
Toronto, ON
M6A 3B4
Canada

Phone	+1 647-812-2113
Email	kstaikin@tidhi.ca

Study information

Primary study design	Observational
Study design	Multicenter prospective observational non-interventional single-arm cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	SHIFT-IBD: Switching to high-efficacy anti-IL-23 guselkumab in ustekinumab-exposed persons with active IBD
Study acronym	SHIFT-IBD
Study objectives	The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies. Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control—without worsening results on medical tests like endoscopy.
Ethics approval(s)	Approved 07/11/2025, Advarra IRB (125 Don Hillock Drive, Unit 18, Aurora, ON, L4G 0H8, Canada; +1 905-727-7989; info@advarra.com), ref: Pro00090978
Health condition(s) or problem(s) studied	Inflammatory Bowel Diseases (IBD)
Intervention	Guselkumab: Induction: 200 mg IV or 400 mg SQ at week 0, 4 and 8. Maintenance: 200 mg SC every 4 weeks from week 12 onwards. Follow up until week 52.
Intervention type	Biological/Vaccine
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Guselkumab
Primary outcome measure(s)	1. Deep remission measured using clinical symptom assessment (absence of symptomatic worsening) and endoscopic evaluation, at Week 52, reported both overall and stratified by treatment cohorts.
Key secondary outcome measure(s)	1. Absence of symptomatic worsening measured using average daily stool frequency score (SFS) and abdominal pain score (APS) for Crohn’s disease, and modified partial Mayo score (m-pMS) for ulcerative colitis, at Week 52 2. Endoscopic remission measured using Simple Endoscopic Score for Crohn’s Disease (SDS-CD) for Crohn’s disease and Mayo endoscopic subscore for ulcerative colitis, at Week 52 3. Endoscopic response measured using change from baseline in SDS-CD for Crohn’s disease and Mayo endoscopic subscore for ulcerative colitis, at Week 52 4. Absence of symptomatic worsening at any study visit measured using SFS and APS for Crohn’s disease, and m-pMS for ulcerative colitis, at Week 4, Week 12, Week 32, and Week 52 5. Symptomatic remission among participants not in remission at baseline measured using SFS and APS for Crohn’s disease, and m-pMS for ulcerative colitis, at Week 12 and Week 52 6. Steroid-free remission among corticosteroid users at baseline measured using absence of corticosteroid use and meeting symptomatic remission criteria (SFS and APS for Crohn’s disease, m-pMS for ulcerative colitis), at Week 52 7. Discontinuation of guselkumab therapy measured using study treatment records, at Week 4, Week 12, Week 32, and Week 52
Completion date	31/12/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Subjects of any gender aged ≥ 18. 2. Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%. 3. Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy. 4. For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab. 5. Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician. 6. For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%. 7. Ability and willingness to give written informed consent and comply with the requirements of this study protocol. 8. Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as: * For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of >6 (or >4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment. * For Ulcerative Colitis: Colonoscopy showing Mayo endoscopic subscore ≥2 in any segment, OR presence of erosions or ulcers in any segment.
Key exclusion criteria	1. History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab). 2. Subjects with formal contraindication to guselkumab per the drug label. 3. Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded. 4. Subjects with an ostomy or ileo-anal pouch. 5. Subjects with a history of bowel surgery within 6 months prior to Week 0. 6. Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0. 7. Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment. 8. Subjects on 1 or more concomitant biologics. 9. Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible. 10. Subjects with formal contraindication or unwilling to undergo lower endoscopy. 11. The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Date of first enrolment	08/12/2025
Date of final enrolment	31/12/2026

Locations

Countries of recruitment

Canada

Study participating centre

Toronto Immune and Digestive Health Institute

700 Lawrence Ave. W, Suite 360
Toronto, ON
M6A 3B4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/12/2025: The following changes were made to the study record:
1. The ethics approval was added.
2. The Date of first enrolment was changed from 01/12/2025 to 08/12/2025
07/11/2025: Trial's existence confirmed by Advarra IRB