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

NCT03782376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-04-29

Study results available
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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 with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab approximately 6 mg/kg (IV)

Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.

DRUG

Placebo (SC)

Participants will receive SC injection of placebo at Week 0.

DRUG

Placebo (IV)

Participants will receive IV infusion of placebo at Week 0.

DRUG

Ustekinumab 90 mg (SC) Group 1

Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.

DRUG

Ustekinumab 90 mg (SC) Group 2

Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd. Clinical Trial · Janssen-Cilag Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2022-08-19
Completion
2023-01-10
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782376 on ClinicalTrials.gov