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

Phase 1

Withdrawn

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: JNJ-56022473; Drug: Placebo

• Registration Number: NCT02920424
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Study Start: 2017-06-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27
• Primary Completion: 2019-02-01
• Study Completion: 2019-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: JNJ-56022473 or Placebo (4:1)	JNJ-56022473	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 \[4 active: 1 placebo\]).
Part A: JNJ-56022473 or Placebo (4:1)	Placebo	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 \[4 active: 1 placebo\]).
Part B: JNJ-56022473 or Placebo (5:1)	JNJ-56022473	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.
Part B: JNJ-56022473 or Placebo (5:1)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16	Up to 16 weeks
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of JNJ-56022473	Up to 16 weeks
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies	Up to 16 weeks
Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)	Up to 38 weeks	Whole blood samples collected from subjects enrolled in this study will be examined by qPCR to assess the ability of JNJ-56022473 to initiate the expected effect on target cells.
Counts of Target Cells	Up to 38 weeks	Counts of target cells will be measured by flow cytometry from whole blood.

Trial Locations

Locations (3)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany