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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome:

  • Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16 [ Time Frame: Up to 16 weeks ]
  • Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration [ Time Frame: Up to 16 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum Concentration of JNJ-56022473 [ Time Frame: Up to 16 weeks ]
  • Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies [ Time Frame: Up to 16 weeks ]
  • Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: Up to 38 weeks ]
    Whole blood samples collected from subjects enrolled in this study will be examined by qPCR to assess the ability of JNJ-56022473 to initiate the expected effect on target cells.
  • Counts of Target Cells [ Time Frame: Up to 38 weeks ]
    Counts of target cells will be measured by flow cytometry from whole blood.


Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: September 29, 2016
Date Started: October 2016
Date Completion: February 2019
Last Updated: October 28, 2016
Last Verified: October 2016