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NCT Number: NCT07303686

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:

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.

Recruiting

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Key information

Conditions

Crohn Disease (CD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MUHC - Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location status: Recruiting

Location contact

Waqqas Afif, MD

CONTACT

[email protected]

514-934-1934 ext. 36536

About this study

Participation in this research study will last 12 months and will include 4-6 visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ustekinumab 90 mg SC q8w

Biological

Sub-group switching from Q4w to Q8w

Ustekinumab 90 mg SC q12w

Biological

Sub-group switching from Q8w to Q12w

Primary outcomes

  1. Loss of clinical remission

    Time frame: From treatment switch to end of participation (12 months)

    Proportion of patients experiencing loss of remission

Secondary outcomes

  1. Time-to-loss of Remission

    Time frame: From treatment switch to end of participation (12 months)

  2. Change from Baseline in the C-reactive protein (CRP) level at loss of remission.

    Time frame: 12 months

    To define if CRP level is a predictor of loss of remission.

  3. Change from Baseline in the calprotectin level at loss of remission.

    Time frame: 12 months

    To define if calprotectin level is a predictor of loss of remission.

  4. Disease duration before loss of remission.

    Time frame: Up to 50 years.

    Define if disease duration is a predictor of loss of remission.

  5. Change in drug concentration before loss of remission.

    Time frame: 12 months

    Define if drug concentration in blood is a predictor of loss of remission.

Study contacts

Contact information is provided by the study sponsor or research team.

Waqqas Afif, MD

CONTACT

[email protected]

514-934-1943 ext. 36536

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Janssen Inc.

Registry information

Official study title

Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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