Clinical trial NCT02920424: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
timeFrame: Up to 16 weeks
measure: Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Serum Concentration of JNJ-56022473
timeFrame: Up to 16 weeks
measure: Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
timeFrame: Up to 16 weeks
measure: Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)
timeFrame: Up to 38 weeks
measure: Counts of Target Cells
timeFrame: Up to 38 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: