Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wi...
Detailed Description
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administra...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03782376
Start Date
December 20 2018
End Date
January 10 2023
Last Update
April 29 2025
Active Locations (104)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
3
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224