drugset / Trial / NCT02877134
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
Timeline
- Start
- 2016-08-25
- Primary completion
- 2020-12-10
- Completion
- 2022-01-24
Publications
- Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
- Allez M, Sands BE, Feagan BG, D'Haens G, De Hertogh G, Randall CW, Zou B, Johanns J, O'Brien C, Curran M, Rebuck R, Wang ML, Sabins N, Baker T, Kobayashi T. A Phase 2b, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study Evaluating the Safety and Efficacy of Tesnatilimab in Patients with Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2023 Aug 21;17(8):1235-1251. doi: 10.1093/ecco-jcc/jjad047.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-64304500 | Unknown | 25 mg | Subcutaneous |
| Subject | JNJ-64304500 | Unknown | 75 mg | Subcutaneous |
| Subject | JNJ-64304500 | Unknown | 200 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |