A Phase 1 interventional study of JNJ-55920839 and Placebo in Systemic Lupus Erythematosus and Healthy, sponsored by Janssen Research & Development, LLC. Completed at 16 sites in 7 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).
This is a Phase 1, randomized, placebo-controlled, multicenter study of JNJ-55920839. The study consists of Screening Period of 28 days. The healthy participants will have a 6-day/5-night inpatient period. All Participants will receive study agent on Day 1 and SLE Participants will receive additional doses on Days 15, 29, 43, 57, and 71. The total duration of participation for each participant will be approximately 13 weeks for healthy participants, 22 weeks for participants with SLE. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of JNJ55920839 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion or as a subcutaneous injection. In Part 2, multiple doses of JNJ-55920839 or placebo will be administered as IV infusions to participants with SLE. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2, along with assessment of safety and clinical outcomes. Participants' safety will be monitored throughout the study.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 72 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Part A (Healthy Participants)
Part B (Participants with Systemic Lupus Erythematosus)
Exclusion Criteria:
Part A (Healthy Participants)
Part B (Systemic Lupus Erythematosus [SLE] )
Drug JNJ-55920839 or Placebo administered IV infusion Dose 1.
Drug: JNJ-55920839 · Drug: Placebo
Drug JNJ-55920839 or Placebo administered IV infusion Dose 2.
Drug: JNJ-55920839 · Drug: Placebo
Drug JNJ-55920839 or Placebo administered IV infusion Dose 3.
Drug: JNJ-55920839 · Drug: Placebo
Drug JNJ-55920839 or Placebo administered IV infusion Dose 4.
Drug: JNJ-55920839 · Drug: Placebo
Drug JNJ-55920839 or Placebo administered IV infusion Dose 5.
Drug: JNJ-55920839 · Drug: Placebo
Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6.
Drug: JNJ-55920839 · Drug: Placebo
Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.
Drug: JNJ-55920839 · Drug: Placebo
JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Also known as: CNTO 6358
0.9 percent (%) normal saline.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 13
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 22
Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after SC injection in Part A
Time frame: Up to Day 64 after dose
Area under the serum concentration versus time curve between 2 defined sample points, t1 and t2 (AUCt1-t2) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Terminal half-life (T1/2) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after SC injection in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Bioavailability (F) after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B
Time frame: Up to Day 130 after dose
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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