CClinicalTrials.gg
CompletedNCT02609789Updated Feb 3, 2025

A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

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

From the registry’s dates

  • Primary completion was Sep 2018, 8 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Healthy

Keywords

  • Systemic Lupus Erythematosus
  • JNJ-55920839
  • Healthy Volunteers
  • CNTO 6358
03

In context

Lupus Erythematosus, Systemic

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Part A (Healthy Participants)

  • Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
  • Participant must have a body weight in the range of 50 to 90 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 30 kilogram per square meters kg/m\^2, inclusive, at screening
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. The determination that there is no evidence of active underlying illness by physical examination must be recorded in the Participant's source documents and initialed by the investigator
  • Participant must be healthy on the basis of clinical laboratory tests performed at screening
  • Before randomization, a woman must be: Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 international units per liters (IU/L) or mIU/mL); permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 4 months (>= 5 half-lives) after receiving last dose of study agent
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 4 months (>=5 half-lives) after receiving the last dose of study agent

Part B (Participants with Systemic Lupus Erythematosus)

  • Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
  • Participant must have a body weight in the range of 40 to 100 kg, inclusive, and have a BMI of 18 to 30 kilograms per square meters (kg/m\^2), inclusive, at screening
  • Must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus

Exclusion criteria

Exclusion Criteria:

Part A (Healthy Participants)

  • Coexisting medical conditions or past medical history: Participant currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant should exclude the participant, including (but not limited to), neuromuscular disorder, hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. Careful consideration should be given to whether the participant has had severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current signs and symptoms thereof
  • Participant has a condition that might confound assessments including major surgery, substance abuse or acute illness
  • Participant is a woman of childbearing potential or a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months (>=5 half-lives) after the last dose of study agent

Part B (Systemic Lupus Erythematosus [SLE] )

  • Participant with history or suspected occurrence of drug-induced SLE
  • Participant has active Central nervous system (CNS) lupus or history of severe CNS lupus including but not limited to seizures, psychosis, transverse myelitis, CNS vasculitis and optic neuritis
  • Participant currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant should exclude the Participant, including (but not limited to), neuromuscular disorder, hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. Careful consideration should be given to whether the Participant has had severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current signs and symptoms thereof
  • Participant has had major surgery, (e.g., requiring general anesthesia) within 4 months before screening, or will not have fully recovered from surgery, or has surgery planned within 4 weeks prior to study agent administration or during the time the Participant is expected to participate in the study, or within 4 months (>=5 half-lives) after the last dose of study agent administration
  • Participant has laboratory findings or biopsy results consistent with severe lupus nephritis
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Part A: Dose 1

    Drug JNJ-55920839 or Placebo administered IV infusion Dose 1.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part A: Dose 2

    Drug JNJ-55920839 or Placebo administered IV infusion Dose 2.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part A: Dose 3

    Drug JNJ-55920839 or Placebo administered IV infusion Dose 3.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part A: Dose 4

    Drug JNJ-55920839 or Placebo administered IV infusion Dose 4.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part A: Dose 5

    Drug JNJ-55920839 or Placebo administered IV infusion Dose 5.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part A: Dose 6

    Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6.

    Drug: JNJ-55920839 · Drug: Placebo

  • Experimental
    Part B

    Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.

    Drug: JNJ-55920839 · Drug: Placebo

Interventions

  • DrugJNJ-55920839

    JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.

    Also known as: CNTO 6358

  • DrugPlacebo

    0.9 percent (%) normal saline.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A

    Time frame: Up to Day 64 after dose

  2. Maximum Observed Serum Concentration (Cmax) after SC injection in Part A

    Time frame: Up to Day 64 after dose

  3. Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B

    Time frame: Up to Day 130 after dose

  4. 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

  5. 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

  6. 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

  7. Terminal half-life (T1/2) after IV infusion in Part A

    Time frame: Up to Day 64 after dose

  8. Terminal half-life (T1/2) after SC injection in Part A

    Time frame: Up to Day 64 after dose

  9. Terminal half-life (T1/2) after IV infusion in Part B

    Time frame: Up to Day 130 after dose

  10. Bioavailability (F) after SC injection in Part A

    Time frame: Up to Day 64 after dose

  11. Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A

    Time frame: Up to Day 64 after dose

  12. Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A

    Time frame: Up to Day 64 after dose

  13. Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B

    Time frame: Up to Day 130 after dose

07

Study locations

16 sites
  • Birmingham, Alabama, United States
  • Rochester, Minnesota, United States
  • Durham, North Carolina, United States
  • Leuven, Belgium
  • Merksem, Belgium
  • Chisinau, Moldova, Republic of
  • Otwock, Poland
  • Szczecin, Poland
  • Bucuresti, Romania
  • Timisoara, Romania
  • Barcelona, Spain
  • Madrid, Spain
  • Santiago de Compostela, Spain
  • Sevilla, Spain
  • Kaohsiung, Taiwan
  • Taichung, Taiwan
08

References and documents

Publications

  • Yao Z, Loggia L, Fink D, Chevrier M, Marciniak S, Sharma A, Xu Z. Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon alpha/omega, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus. Clin Drug Investig. 2020 Dec;40(12):1127-1136. doi: 10.1007/s40261-020-00978-4. Epub 2020 Oct 21. PubMed 33085033 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02609789
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Nov 20, 2015
Start date
Dec 2015
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Feb 3, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion