NCT02920424

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

• Status: Withdrawn
• Phase: Phase 1
• 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 assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	JNJ-56022473	Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
DRUG	Placebo	Subjects will receive matching placebo.

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-02-01
• Completion: 2019-09-26
• First posted: 2016-09-30
• Last updated: 2017-11-27

Locations

3 sites across 1 country: Germany