Crohn Disease (CD)Phase 4NCT07303686
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
A Phase 4 study testing Ustekinumab 90 mg SC q8w and Ustekinumab 90 mg SC q12w in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Ustekinumab 90 mg SC q8w and Ustekinumab 90 mg SC q12w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2025to 15 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical remission
- Biochemical remission
- Endoscopy remission
- Not on corticosteroid
- A woman must be ;
- not of childbearing potential
- of childbearing potential and practicing a medically accepted method of contraception.
- Able t provide informed consent
Who cannot join
- On more than one biologics drug
- Use of oral or topical steroids within 6months of study entry
- pregnancy
- Any issue that could lead to non-compliance, as alcohol, drug use
- Unable to provide consent or t comply with follw-up visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
MUHC - Montreal General Hospital
Montreal, Quebec, H3G1A4
Waqqas Afif, MD, 514-934-1934 ext. 36536, miirecherche.ibdresearch@muhc.mcgill.ca
About this study
Official title: Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
The main question it aims to answer is:
Read more
Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission.
Participants will:
Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
Read the detailed description
Participation in this research study will last 12 months and will include 4-6 visits.
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC)
- Being tested
- Ustekinumab 90 mg SC q8w, Ustekinumab 90 mg SC q12w
- Keywords
- CD, UC, ustekinumab, UST
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ustekinumab 90 mg SC q8wBiological
Sub-group switching from Q4w to Q8w
Ustekinumab 90 mg SC q12wBiological
Sub-group switching from Q8w to Q12w
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab Q4w | Other | Not described Receives: Biological: Ustekinumab 90 mg SC q8w |
| Ustekinumab Q8w | Other | Not described Receives: Biological: Ustekinumab 90 mg SC q12w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of clinical remission
Proportion of patients experiencing loss of remission
Measured: From treatment switch to end of participation (12 months)
Secondary outcomes (5)
Time-to-loss of Remission
Measured: From treatment switch to end of participation (12 months)
Change from Baseline in the C-reactive protein (CRP) level at loss of remission.
To define if CRP level is a predictor of loss of remission.
Measured: 12 months
Change from Baseline in the calprotectin level at loss of remission.
To define if calprotectin level is a predictor of loss of remission.
Measured: 12 months
Disease duration before loss of remission.
Define if disease duration is a predictor of loss of remission.
Measured: Up to 50 years.
Change in drug concentration before loss of remission.
Define if drug concentration in blood is a predictor of loss of remission.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Oct 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, waqqas.afif, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303686
- Sponsor's protocol ID
- 2020-5567
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07303686
- Acronym / sponsor ID
- 2020-5567
- Conditions
- Crohn Disease (CD), Ulcerative Colitis (UC)
- Keywords
- CD, UC, ustekinumab, UST
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
The main question it aims to answer is:
Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission.
Participants will:
Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
Detailed description
Participation in this research study will last 12 months and will include 4-6 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab Q4w | Other | Biological: Ustekinumab 90 mg SC q8w |
| Ustekinumab Q8w | Other | Biological: Ustekinumab 90 mg SC q12w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical remission
- Biochemical remission
- Endoscopy remission
- Not on corticosteroid
- A woman must be ;
Key exclusion criteria (5 listed)
- On more than one biologics drug
- Use of oral or topical steroids within 6months of study entry
- pregnancy
- Any issue that could lead to non-compliance, as alcohol, drug use
- Unable to provide consent or t comply with follw-up visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ustekinumab 90 mg SC q8wSub-group switching from Q4w to Q8w | Biological | Ustekinumab Q4w |
| Ustekinumab 90 mg SC q12wSub-group switching from Q8w to Q12w | Biological | Ustekinumab Q8w |
Primary outcome
Loss of clinical remission
Time frame: From treatment switch to end of participation (12 months)
Proportion of patients experiencing loss of remission
5 secondary outcomes
Time-to-loss of Remission
Time frame: From treatment switch to end of participation (12 months)
Change from Baseline in the C-reactive protein (CRP) level at loss of remission.
Time frame: 12 months
Change from Baseline in the calprotectin level at loss of remission.
Time frame: 12 months
Disease duration before loss of remission.
Time frame: Up to 50 years.
Change in drug concentration before loss of remission.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ustekinumab 90 mg SC q8w and Ustekinumab 90 mg SC q12w in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waqqas Afif, MD (514-934-1943 ext. 36536, waqqas.afif@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of clinical remission (time frame: From treatment switch to end of participation (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.