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

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 1

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: JNJ-56022473; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02920424

56022473SLE1001 (Other Identifier)

2016-001260-11 (EudraCT Number)

CR108216

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening

• Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration

• Have a positive gene signature score during screening, prior to first administration of study agent

• Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication:

  1. oral corticosteroids equivalent to an average dose up to or equal to (<=) 10 milligram (mg) of prednisone/day
  2. use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
  3. maximum of 1 non-corticosteroid immunosuppressive drug

Exclusion criteria

• Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE)
• Subject has unstable lupus nephritis and/ or 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
• Major surgery prior to, and, if planned, during and shortly after the study is not eligible
• Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit
• Any other inflammatory diseases that might confound the evaluations of efficacy are excluded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Part A: JNJ-56022473 or Placebo (4:1)

Experimental group

Description:

Subjects will receive 3 subcutaneous (SC) administrations of the same dose level of JNJ-56022473 Dose 1, Dose 2, or Dose 3 or placebo every 2 weeks (in the ratio of 4:1 \[4 active: 1 placebo\]).

Treatment:

Drug: JNJ-56022473

Drug: Placebo

Part B: JNJ-56022473 or Placebo (5:1)

Experimental group

Description:

Subjects will receive 3 SC administrations of the same dose level of JNJ-56022473 or placebo every 2 weeks (in the ratio of 5:1 \[5 active: 1 placebo\]). The dose level(s) will be based upon an interim analysis (IA) of the Part A data.

Treatment:

Drug: JNJ-56022473

Drug: Placebo