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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001260-11 | EudraCT Number | ||
| 56022473SLE1001 | Other Identifier | Janssen Research & Development, LLC |
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The decision is based on a change in the benefit risk assessment of this drug for the lupus population targeted in this study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: JNJ-56022473 or Placebo (4:1) | Experimental | 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]). |
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| Part B: JNJ-56022473 or Placebo (5:1) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-56022473 | Drug | Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels. |
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| Measure | Description | 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 |
| 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) |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany | |||
| Medizinische Hochschule Hannover |
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| Placebo | Drug | Subjects will receive matching placebo. |
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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 |
| Hanover |
| 30625 |
| Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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