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

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02920424
• Other study ID #: CR108216
• Secondary ID: 2016-001260-1156
• Status: Withdrawn
• Phase: Phase 1
• First received: September 29, 2016
• Last updated: November 23, 2017
• Start date: June 30, 2017
• Est. completion date: September 26, 2019

Study information

• Verified date: November 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 26, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• JNJ-56022473
Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
• Placebo
Subjects will receive matching placebo.

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16		Up to 16 weeks
Primary	Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration		Up to 16 weeks
Secondary	Serum Concentration of JNJ-56022473		Up to 16 weeks
Secondary	Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies		Up to 16 weeks
Secondary	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
Secondary	Counts of Target Cells	Counts of target cells will be measured by flow cytometry from whole blood.	Up to 38 weeks