NCT02609789

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus

Completed Phase 1 Last updated 31 January 2025

What this trial tests

Phase 1 trial testing JNJ-55920839 in Systemic Lupus Erythematosus in 72 participants. Completed in 1 September 2018.

Timeline

1 December 2015

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	72
Start date	1 December 2015
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	16 locations across United States, Belgium, Moldova, Poland, Romania, Spain, Taiwan

Drugs / interventions tested

• JNJ-55920839 — full drug profile →
• Placebo

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
• Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Systemic Lupus Erythematosus or Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1)
  Time frame: Through Week 13
  The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
• Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2)
  Time frame: Through Week 22
  The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytokines as Biomarkers in Systemic Lupus Erythematosus: Value for Diagnosis and Drug Therapy.
   Idborg H, Oke V. · · 2021 · cited 40× · PMID 34768756 · DOI 10.3390/ijms222111327
2. Novel Treatments in Lupus.
   Vukelic M, Li Y, Kyttaris VC. · · 2018 · cited 32× · PMID 30524430 · DOI 10.3389/fimmu.2018.02658
3. Type I interferon antagonists in clinical development for lupus.
   Paredes JL, Niewold TB. · · 2020 · cited 16× · PMID 32700979 · DOI 10.1080/13543784.2020.1797677
4. First-in-Human study of JNJ-55920839 in healthy volunteers and patients with systemic lupus erythematosus: a randomised placebo-controlled phase 1 trial.
   Jordan J, Benson J, Chatham WW, Furie RA, et al · · 2020 · cited 9× · PMID 38273624 · DOI 10.1016/s2665-9913(20)30223-x
5. Type I Interferons in Systemic Autoimmune Rheumatic Diseases: Pathogenesis, Clinical Features and Treatment Options.
   Drougkas K, Skarlis C, Mavragani C. · · 2024 · cited 4× · PMID 39193187 · DOI 10.31138/mjr.270324.tis
6. Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon α/ω, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus.
   Yao Z, Loggia L, Fink D, Chevrier M, et al · · 2020 · cited 3× · PMID 33085033 · DOI 10.1007/s40261-020-00978-4