A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Leuven, Belgium
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Merksem, Belgium
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Chisinau, Moldova, Republic of
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Otwock, Poland
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Szczecin, Poland
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Bucuresti, Romania
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Timisoara, Romania
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Barcelona, Spain
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Madrid, Spain
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Santiago de Compostela, Spain
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Sevilla, Spain
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Alabama
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Birmingham, Alabama, United States
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Minnesota
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Rochester, Minnesota, United States
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North Carolina
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Durham, North Carolina, United States
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Experimental: Part A: Dose 1
Drug JNJ-55920839 or Placebo administered IV infusion Dose 1.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part A: Dose 2
Drug JNJ-55920839 or Placebo administered IV infusion Dose 2.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part A: Dose 3
Drug JNJ-55920839 or Placebo administered IV infusion Dose 3.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part A: Dose 4
Drug JNJ-55920839 or Placebo administered IV infusion Dose 4.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part A: Dose 5
Drug JNJ-55920839 or Placebo administered IV infusion Dose 5.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part A: Dose 6
Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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Experimental: Part B
Participants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion.
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JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
Other Names:
0.9 percent (%) normal saline.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
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Through Week 13
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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
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The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
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Through Week 22
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Time Frame: Up to Day 130 after dose
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Up to Day 130 after dose
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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
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Up to Day 64 after dose
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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
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Up to Day 64 after dose
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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
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Up to Day 130 after dose
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Terminal half-life (T1/2) after IV infusion in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Terminal half-life (T1/2) after SC injection in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Terminal half-life (T1/2) after IV infusion in Part B
Time Frame: Up to Day 130 after dose
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Up to Day 130 after dose
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Bioavailability (F) after SC injection in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A
Time Frame: Up to Day 64 after dose
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Up to Day 64 after dose
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Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B
Time Frame: Up to Day 130 after dose
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Up to Day 130 after dose
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CR108073
- 55920839SLE1001 (Other Identifier: Janssen Research & Development, LLC)
- 2014-005605-21 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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