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

NCT ID: NCT02920424

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2019-09-26

Brief Summary

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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 \[4 active: 1 placebo\]).

Group Type: EXPERIMENTAL

JNJ-56022473

Intervention Type: DRUG

Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo.

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

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.

Group Type: EXPERIMENTAL

JNJ-56022473

Intervention Type: DRUG

Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo.

Interventions

JNJ-56022473

Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.

Intervention Type: DRUG

Placebo

Subjects will receive matching placebo.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Charité Research Organisation GmbH

Berlin, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Countries

Germany

Other Identifiers

2016-001260-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

56022473SLE1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108216

Identifier Type: -

Identifier Source: org_study_id