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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: JNJ-56022473; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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]).	Drug: JNJ-56022473; Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.; Drug: Placebo; Subjects will receive matching placebo.
EXPERIMENTAL: 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.	Drug: JNJ-56022473; Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.; Drug: Placebo; Subjects will receive matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)	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.	Up to 38 weeks
Counts of Target Cells	Counts of target cells will be measured by flow cytometry from whole blood.	Up to 38 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 30, 2017
• Primary Completion (ANTICIPATED): February 1, 2019
• Study Completion (ANTICIPATED): September 26, 2019

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (ESTIMATE): September 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: CR108216; 2016-001260-11 (EUDRACT_NUMBER); 56022473SLE1001 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No