A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

NCT02609789 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: CR10807355920839SLE10012014-005605-21
• Study Type: interventional
• Target: 72
• Locations: 7 countries
• Sites: 16

Brief Summary

The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus; Healthy

Keywords

Systemic Lupus Erythematosus; JNJ-55920839; Healthy Volunteers; CNTO 6358

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1)

  The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

  Through Week 13

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2)

  The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

  Through Week 22

Secondary Outcomes (13)

• Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A

  Up to Day 64 after dose

• Maximum Observed Serum Concentration (Cmax) after SC injection in Part A

  Up to Day 64 after dose

• Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B

  Up to Day 130 after dose

• Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after IV infusion in Part A

  Up to Day 64 after dose

• Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after SC injection in Part A

  Up to Day 64 after dose

Study Arms (7)

Part A: Dose 1

EXPERIMENTAL

Drug JNJ-55920839 or Placebo administered IV infusion Dose 1.

Drug: JNJ-55920839; Drug: Placebo

Part A: Dose 2

EXPERIMENTAL

Drug JNJ-55920839 or Placebo administered IV infusion Dose 2.

Drug: JNJ-55920839; Drug: Placebo

Part A: Dose 3

EXPERIMENTAL

Drug JNJ-55920839 or Placebo administered IV infusion Dose 3.

Drug: JNJ-55920839; Drug: Placebo

Part A: Dose 4

EXPERIMENTAL

Drug JNJ-55920839 or Placebo administered IV infusion Dose 4.

Drug: JNJ-55920839; Drug: Placebo

Part A: Dose 5

EXPERIMENTAL

Drug JNJ-55920839 or Placebo administered IV infusion Dose 5.

Drug: JNJ-55920839; Drug: Placebo

Part A: Dose 6

EXPERIMENTAL

Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6.

Drug: JNJ-55920839; Drug: Placebo

Part B

EXPERIMENTAL

Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.

Drug: JNJ-55920839; Drug: Placebo

Interventions

JNJ-55920839 DRUG

JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.

Also known as: CNTO 6358

Part A: Dose 1; Part A: Dose 2; Part A: Dose 3; Part A: Dose 4; Part A: Dose 5; Part A: Dose 6; Part B

Placebo DRUG

0.9 percent (%) normal saline.

Part A: Dose 1; Part A: Dose 2; Part A: Dose 3; Part A: Dose 4; Part A: Dose 5; Part A: Dose 6; Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part A (Healthy Participants)
• Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
• Participant must have a body weight in the range of 50 to 90 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 30 kilogram per square meters kg/m\^2, inclusive, at screening
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. The determination that there is no evidence of active underlying illness by physical examination must be recorded in the Participant's source documents and initialed by the investigator
• Participant must be healthy on the basis of clinical laboratory tests performed at screening
• Before randomization, a woman must be: Not of childbearing potential: postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 international units per liters (IU/L) or mIU/mL); permanently sterilized (e.g., bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 4 months (\>= 5 half-lives) after receiving last dose of study agent
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 4 months (\>=5 half-lives) after receiving the last dose of study agent
• Part B (Participants with Systemic Lupus Erythematosus)
• Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
• Participant must have a body weight in the range of 40 to 100 kg, inclusive, and have a BMI of 18 to 30 kilograms per square meters (kg/m\^2), inclusive, at screening
• Must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus

You may not qualify if:

• Part A (Healthy Participants)
• Coexisting medical conditions or past medical history: Participant currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant should exclude the participant, including (but not limited to), neuromuscular disorder, hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. Careful consideration should be given to whether the participant has had severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current signs and symptoms thereof
• Participant has a condition that might confound assessments including major surgery, substance abuse or acute illness
• Participant is a woman of childbearing potential or a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months (\>=5 half-lives) after the last dose of study agent
• Part B (Systemic Lupus Erythematosus \[SLE\] )
• Participant with history or suspected occurrence of drug-induced SLE
• Participant 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
• Participant currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant should exclude the Participant, including (but not limited to), neuromuscular disorder, hematological disease, immune deficiency states, respiratory disease, cardiovascular disease (including poor peripheral venous access), hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. Careful consideration should be given to whether the Participant has had severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current signs and symptoms thereof
• Participant has had major surgery, (e.g., requiring general anesthesia) within 4 months before screening, or will not have fully recovered from surgery, or has surgery planned within 4 weeks prior to study agent administration or during the time the Participant is expected to participate in the study, or within 4 months (\>=5 half-lives) after the last dose of study agent administration
• Participant has laboratory findings or biopsy results consistent with severe lupus nephritis

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (16)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Merksem, Belgium

Location

Unknown Facility

Chisinau, Moldova

Location

Unknown Facility

Otwock, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Timișoara, Romania

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Related Publications (2)

• Jordan J, Benson J, Chatham WW, Furie RA, Stohl W, Wei JC, Marciniak S, Yao Z, Srivastava B, Schreiter J, Cesaroni M, Orillion A, Seridi L, Chevrier M. First-in-Human study of JNJ-55920839 in healthy volunteers and patients with systemic lupus erythematosus: a randomised placebo-controlled phase 1 trial. Lancet Rheumatol. 2020 Oct;2(10):e613-e622. doi: 10.1016/S2665-9913(20)30223-X. Epub 2020 Aug 21.

  PMID: 38273624 DERIVED

• Yao Z, Loggia L, Fink D, Chevrier M, Marciniak S, Sharma A, Xu Z. Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon alpha/omega, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus. Clin Drug Investig. 2020 Dec;40(12):1127-1136. doi: 10.1007/s40261-020-00978-4. Epub 2020 Oct 21.

  PMID: 33085033 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

JNJ-55920839

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: November 18, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

BE (2); MO (1); US (3); PL (2); ES (4); RO (2); TW (2)