A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Key facts

Study ID

NCT03782376

Run by

Janssen-Cilag Ltd.

People needed

215

Starts

2018-12-20

Expected to finish

2023-01-10

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and <=450 with at least one of the following: Elevated C-reactive protein (CRP) (>3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin (fCal) >250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or equal to (<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon)
• Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral corticosteroids (for example {e.g.}, prednisone, budesonide) at a prednisone-equivalent dose of <=40 mg/day or <=9 mg/day of budesonide, antibiotics used as the primary treatment of Crohn's disease, or conventional immunomodulators (i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are permitted providing the doses indicated are stable before baseline or have been discontinued before baseline within the protocol defined durations

You may not qualify if…

• Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
• Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
• Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
• A draining (i.e., functioning) stoma or ostomy
• Received ustekinumab intravenous re-induction after the initial weight-tiered-based IV induction dose of ustekinumab
• Any known history of shortened frequency of SC dose administration (<q8w) for a secondary loss of response where the participant did not, in the opinion of the treating physician, benefit from the dose interval shortening

Where it is running

• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Florida Research Network, LLC — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Advent Health — Orlando, Florida, United States
• Florida Hospital Tampa — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's — Atlanta, Georgia, United States
• Atlanta Gastroenterology Specialists — Suwanee, Georgia, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Brigham And Women's Hospital — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Ohio State University Hospital — Hilliard, Ohio, United States
• Northshore Gastroenterology Research, LLC — Westlake, Ohio, United States
• Oklahoma Digestive Disease Specialists — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Digestive Disease Consultants — Cedar Park, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Gastroenterology Research of America, LLC — San Antonio, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• University of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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