NCT04655807

A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn's disease in response but not remission to SOC biologic therapy.

Detailed description

Biologic agents such as anti-tumor necrosis factor (TNF) and interleukin (IL)-12/23 antagonists have become the standard of care (SOC) in the treatment of patients with Crohn's disease. However, many patients fail to fully respond to treatment. This study will evaluate the efficacy of 10 week add on treatment with JNJ-64304500, compared to placebo, in patients taking SOC anti-TNF or anti-IL12/23 biologics. The study consists of a screening phase (up to 8 weeks); treatment phase (up to 12 weeks and follow-up phase (up to 16 weeks after the last administration of study agent). The total study duration will be up to 34 weeks. Key safety assessments include adverse events, clinical laboratory tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	JNJ-64304500	JNJ-64304500 will be administered as SC injection.
DRUG	Placebo	Matching placebo will be administered as SC injection.
DRUG	Adalimumab	Adalimumab will be administered as SOC biological therapy.
DRUG	Ustekinumab	Ustekinumab will be administered as SOC biological therapy.

Timeline

• Start date: 2021-03-03
• Primary completion: 2023-05-24
• Completion: 2023-09-04
• First posted: 2020-12-07
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study