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JNJ-55920839

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-55920839 · 1 trial · 2 indications

Phase 1 1
NCT02609789A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus Erythematosus
COMPLETED72 Analytics
PHASE1COMPLETED
A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1)
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)
Through Week 22

The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

Secondary Endpoints

Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Up to Day 64 after dose
Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Up to Day 64 after dose
Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Up to Day 130 after dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose 1EXPERIMENTALDrug JNJ-55920839 or Placebo administered IV infusion Dose 1.
Part A: Dose 2EXPERIMENTALDrug JNJ-55920839 or Placebo administered IV infusion Dose 2.
Part A: Dose 3EXPERIMENTALDrug JNJ-55920839 or Placebo administered IV infusion Dose 3.
Part A: Dose 4EXPERIMENTALDrug JNJ-55920839 or Placebo administered IV infusion Dose 4.
Part A: Dose 5EXPERIMENTALDrug JNJ-55920839 or Placebo administered IV infusion Dose 5.
Part A: Dose 6EXPERIMENTALDrug JNJ-55920839 or Placebo subcutaneous injection Dose 6.
Part BEXPERIMENTALParticipants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.

Interventions

NameTypeDescription
JNJ-55920839DRUGJNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
PlaceboDRUG0.9 percent (%) normal saline.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites16

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 ...

Countries:United StatesBelgiumMoldovaPolandRomaniaSpainTaiwan
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Frequently asked questions about JNJ-55920839

What is JNJ-55920839 used for?

JNJ-55920839 is an investigational small molecule being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.

Who makes JNJ-55920839?

JNJ-55920839 is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for Systemic Lupus Erythematosus.

What phase is JNJ-55920839 in?

JNJ-55920839 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with Systemic Lupus Erythematosus.

What clinical trials is JNJ-55920839 in?

JNJ-55920839 has been studied in one clinical trial, identified as NCT02609789. This was a Phase 1 study that included a single ascending dose study in healthy participants and a multiple dose study in participants with mild to moderate Systemic Lupus Erythematosus. The trial has been completed.

Is JNJ-55920839 the same as any other drug?

JNJ-55920839 is the only name provided for this investigational drug. It is a small molecule being developed by Johnson & Johnson for Systemic Lupus Erythematosus and is currently in Phase 1 clinical trials.