Back to resultsA Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
Primary Purpose
Lupus Erythematosus, Systemic
Status
Withdrawn
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
JNJ-56022473
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic
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:
- oral corticosteroids equivalent to an average dose up to or equal to (<=) 10 milligram (mg) of prednisone/day
- use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
- 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
Sites / Locations
- Charité Research Organisation GmbH
- Medizinische Hochschule Hannover
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: JNJ-56022473 or Placebo (4:1)
Part B: JNJ-56022473 or Placebo (5:1)
Arm 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]).
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.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
Secondary Outcome Measures
Serum Concentration of JNJ-56022473
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
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.
Counts of Target Cells
Counts of target cells will be measured by flow cytometry from whole blood.
Full Information
NCT ID
NCT02920424
First Posted
September 29, 2016
Last Updated
November 23, 2017
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02920424
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The decision is based on a change in the benefit risk assessment of this drug for the lupus population targeted in this study.
Study Start Date
June 30, 2017 (Anticipated)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
September 26, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: JNJ-56022473 or Placebo (4:1)
Arm Type
Experimental
Arm 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]).
Arm Title
Part B: JNJ-56022473 or Placebo (5:1)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
JNJ-56022473
Intervention Description
Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive matching placebo.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
Time Frame
Up to 16 weeks
Title
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Serum Concentration of JNJ-56022473
Time Frame
Up to 16 weeks
Title
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
Time Frame
Up to 16 weeks
Title
Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)
Description
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.
Time Frame
Up to 38 weeks
Title
Counts of Target Cells
Description
Counts of target cells will be measured by flow cytometry from whole blood.
Time Frame
Up to 38 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
oral corticosteroids equivalent to an average dose up to or equal to (<=) 10 milligram (mg) of prednisone/day
use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Charité Research Organisation GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
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