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

NCT02920424 | Withdrawn Phase 1

• 3 other identifiers: CR1082162016-001260-1156022473SLE1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

  Up to 38 weeks

• Counts of Target Cells

  Up to 38 weeks

Study Arms (2)

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 \[4 active: 1 placebo\]).

Drug: JNJ-56022473; Drug: Placebo

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.

Drug: JNJ-56022473; Drug: Placebo

Interventions

JNJ-56022473 DRUG

Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.

Part A: JNJ-56022473 or Placebo (4:1); Part B: JNJ-56022473 or Placebo (5:1)

Placebo DRUG

Subjects will receive matching placebo.

Part A: JNJ-56022473 or Placebo (4:1); Part B: JNJ-56022473 or Placebo (5:1)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: June 30, 2017
• Primary Completion: February 1, 2019
• Study Completion: September 26, 2019
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

DE (3)