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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02609789

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Healthy	Drug: JNJ-55920839 Drug: Placebo	Phase 1

Detailed Description

This is a Phase 1, randomized, placebo-controlled, multicenter study of JNJ-55920839. The study consists of Screening Period of 28 days. The healthy participants will have a 6-day/5-night inpatient period. All Participants will receive study agent on Day 1 and SLE Participants will receive additional doses on Days 15, 29, 43, 57, and 71. The total duration of participation for each participant will be approximately 13 weeks for healthy participants, 22 weeks for participants with SLE. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of JNJ55920839 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion or as a subcutaneous injection. In Part 2, multiple doses of JNJ-55920839 or placebo will be administered as IV infusions to participants with SLE. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2, along with assessment of safety and clinical outcomes. Participants' safety will be monitored throughout the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Dose 1 Drug JNJ-55920839 or Placebo administered IV infusion Dose 1.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part A: Dose 2 Drug JNJ-55920839 or Placebo administered IV infusion Dose 2.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part A: Dose 3 Drug JNJ-55920839 or Placebo administered IV infusion Dose 3.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part A: Dose 4 Drug JNJ-55920839 or Placebo administered IV infusion Dose 4.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part A: Dose 5 Drug JNJ-55920839 or Placebo administered IV infusion Dose 5.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part A: Dose 6 Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.
Experimental: Part B Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.	Drug: JNJ-55920839 JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. Other Names: CNTO 6358 Drug: Placebo 0.9 percent (%) normal saline.

Outcome Measures

Primary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1) [Through Week 13]
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2) [Through Week 22]
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

Secondary Outcome Measures

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]
Area under the serum concentration versus time curve between 2 defined sample points, t1 and t2 (AUCt1-t2) after IV infusion in Part B [Up to Day 130 after dose]
Terminal half-life (T1/2) after IV infusion in Part A [Up to Day 64 after dose]
Terminal half-life (T1/2) after SC injection in Part A [Up to Day 64 after dose]
Terminal half-life (T1/2) after IV infusion in Part B [Up to Day 130 after dose]
Bioavailability (F) after SC injection in Part A [Up to Day 64 after dose]
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A [Up to Day 64 after dose]
Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A [Up to Day 64 after dose]
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B [Up to Day 130 after dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Rochester	Minnesota	United States
3	Durham	North Carolina	United States
4	Leuven		Belgium
5	Merksem		Belgium
6	Chisinau		Moldova, Republic of
7	Otwock		Poland
8	Szczecin		Poland
9	Bucuresti		Romania
10	Timisoara		Romania
11	Barcelona		Spain
12	Madrid		Spain
13	Santiago De Compostela		Spain
14	Sevilla		Spain
15	Kaohsiung		Taiwan
16	Taichung		Taiwan

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT02609789

Other Study ID Numbers:

CR108073
55920839SLE1001
2014-005605-21

First Posted:

Nov 20, 2015

Last Update Posted:

Mar 14, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Janssen Research & Development, LLC

Systemic Lupus Erythematosus

JNJ-55920839

Healthy Volunteers

CNTO 6358

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Mar 14, 2019