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Induction Optimization With Stelara for Crohn's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Induction Optimization With Stelara for Crohn's Disease

NCT04629196•NYU Langone Health

Summary

This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females between the ages of 18 and 70
•2. History of Crohn's disease for at least 3 months confirmed by colonoscopy and/or cross sectional imaging reviewed by the PI
•3. Moderate to Severe Crohn's disease defined as a CDAI between 220 and 450
•4. Either a CRP \>8mg/L or a fecal calprotectin \> 250ug/g within 4 weeks of starting ustekinumab
•5. Stable Concomitant medications (prior to first dose of ustekinumab)
•1. Stable dose of 6-MP, azathioprine, or methotrexate for at least 4 weeks
•2. Stable dose of oral mesalamine for at least 2 weeks
•3. Stable dose of prednisone of 20mg or less or budesonide 9mg daily for at least 2 weeks
•6. If subject is a female, before randomization she must be:
•a. Postmenopausal, defined as
+9 more criteria

Exclusion Criteria

•1. Past Stelara or anti-IL 23 use.
•2. Active infection.
•3. Has any known malignancy or has a history of malignancy (except for basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening).
•4. Indeterminate colitis.
•5. Active perianal fistula as the primary symptom.
•6. Fibrostenotic disease with primarily obstructive symptoms.
•7. Hospitalization within the past 2 weeks.
•8. Bowel resection within the past 4 weeks.
•9. Subtotal colectomy.
•10. Permanent Ileostomy.
+18 more criteria

Locations (2)

University of Maryland

Baltimore, Maryland, United States

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

February 16, 2022

Primary Completion Date

January 17, 2024

Completion Date

January 17, 2024

Last Updated

November 5, 2024

Enrollment

ACTUAL participants

Conditions

Crohn Disease

Interventions

Ustekinumab

DRUG

Ustekinumab

DRUG

Ustekinumab

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Induction Optimization With Stelara for Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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