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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609789
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CNTO 6358

Drug: Placebo
0.9 percent (%) normal saline.




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

  2. Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2) [ Time Frame: 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 :
  1. Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A [ Time Frame: Up to Day 64 after dose ]
  2. Maximum Observed Serum Concentration (Cmax) after SC injection in Part A [ Time Frame: Up to Day 64 after dose ]
  3. Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B [ Time Frame: Up to Day 130 after dose ]
  4. 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 [ Time Frame: Up to Day 64 after dose ]
  5. 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 [ Time Frame: Up to Day 64 after dose ]
  6. Area under the serum concentration versus time curve between 2 defined sample points, t1 and t2 (AUCt1-t2) after IV infusion in Part B [ Time Frame: Up to Day 130 after dose ]
  7. Terminal half-life (T1/2) after IV infusion in Part A [ Time Frame: Up to Day 64 after dose ]
  8. Terminal half-life (T1/2) after SC injection in Part A [ Time Frame: Up to Day 64 after dose ]
  9. Terminal half-life (T1/2) after IV infusion in Part B [ Time Frame: Up to Day 130 after dose ]
  10. Bioavailability (F) after SC injection in Part A [ Time Frame: Up to Day 64 after dose ]
  11. Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A [ Time Frame: Up to Day 64 after dose ]
  12. Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A [ Time Frame: Up to Day 64 after dose ]
  13. Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B [ Time Frame: Up to Day 130 after dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609789


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, North Carolina
Durham, North Carolina, United States
Belgium
Leuven, Belgium
Merksem, Belgium
Moldova, Republic of
Chisinau, Moldova, Republic of
Poland
Otwock, Poland
Szczecin, Poland
Romania
Bucuresti, Romania
Timisoara, Romania
Spain
Barcelona, Spain
Madrid, Spain
Santiago De Compostela, Spain
Sevilla, Spain
Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02609789    
Other Study ID Numbers: CR108073
55920839SLE1001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005605-21 ( EudraCT Number )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Systemic Lupus Erythematosus
JNJ-55920839
Healthy Volunteers
CNTO 6358
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases