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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02920424
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: June 30, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02920424
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo

Drug: JNJ-56022473

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR) [Time Frame: Up to 38 weeks]

Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies [Time Frame: Up to 16 weeks]

Counts of Target Cells [Time Frame: Up to 38 weeks]

Serum Concentration of JNJ-56022473 [Time Frame: Up to 16 weeks]

Secondary ID(s)

56022473SLE1001

CR108216

2016-001260-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors