Systemic Lupus ErythematosusPhase 1NCT02609789
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 study testing JNJ-55920839 in people with Systemic Lupus Erythematosus and Healthy, run by Janssen Research & Development, LLC at 16 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Healthy
- What is being tested?
- JNJ-55920839
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 16 sitesin 7 countries
- Study dates
- Dec 2015to Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Santiago de Compostela
Study site
Seville
United States3 sites
Study site
Birmingham, Alabama
Study site
Durham, North Carolina
Study site
Rochester, Minnesota
About this study
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
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).
Read the 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.
- Conditions
- Systemic Lupus Erythematosus, Healthy
- Being tested
- JNJ-55920839, Placebo
- Keywords
- Systemic Lupus Erythematosus, JNJ-55920839, Healthy Volunteers, CNTO 6358
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-55920839Drug
Also called CNTO 6358
JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
PlaceboDrug
0.9 percent (%) normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose 1 | Experimental | Drug JNJ-55920839 or Placebo administered IV infusion Dose 1. Receives: Drug: JNJ-55920839; Drug: Placebo |
| Part A: Dose 2 | Experimental | Drug JNJ-55920839 or Placebo administered IV infusion Dose 2. Receives: Drug: JNJ-55920839; Drug: Placebo |
| Part A: Dose 3 | Experimental | Drug JNJ-55920839 or Placebo administered IV infusion Dose 3. Receives: Drug: JNJ-55920839; Drug: Placebo |
| Part A: Dose 4 | Experimental | Drug JNJ-55920839 or Placebo administered IV infusion Dose 4. Receives: Drug: JNJ-55920839; Drug: Placebo |
| Part A: Dose 5 | Experimental | Drug JNJ-55920839 or Placebo administered IV infusion Dose 5. Receives: Drug: JNJ-55920839; Drug: Placebo |
| Part A: Dose 6 | Experimental | Drug JNJ-55920839 or Placebo subcutaneous injection Dose 6. Receives: 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. Receives: Drug: JNJ-55920839; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through Week 22
Secondary outcomes (13)
Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Measured: Up to Day 64 after dose
Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Measured: Up to Day 64 after dose
Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 130 after dose
Terminal half-life (T1/2) after IV infusion in Part A
Measured: Up to Day 64 after dose
Terminal half-life (T1/2) after SC injection in Part A
Measured: Up to Day 64 after dose
Terminal half-life (T1/2) after IV infusion in Part B
Measured: Up to Day 130 after dose
Bioavailability (F) after SC injection in Part A
Measured: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A
Measured: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A
Measured: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B
Measured: Up to Day 130 after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609789
- Sponsor's protocol ID
- CR108073
- Other IDs
- 55920839SLE1001, 2014-005605-21, 2014
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38273624Yao 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.
PubMed 33085033
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02609789
- Acronym / sponsor ID
- CR108073
- Conditions
- Systemic Lupus Erythematosus, Healthy
- Keywords
- Systemic Lupus Erythematosus, JNJ-55920839, Healthy Volunteers, CNTO 6358
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose 1 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo administered IV infusion Dose 1. |
| Part A: Dose 2 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo administered IV infusion Dose 2. |
| Part A: Dose 3 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo administered IV infusion Dose 3. |
| Part A: Dose 4 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo administered IV infusion Dose 4. |
| Part A: Dose 5 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo administered IV infusion Dose 5. |
| Part A: Dose 6 | Experimental | Drug: JNJ-55920839, Drug: PlaceboDrug JNJ-55920839 or Placebo subcutaneous injection Dose 6. |
| Part B | Experimental | Drug: JNJ-55920839, Drug: PlaceboParticipants will receive 6 doses of JNJ-55920839 or placebo (every 2 weeks) as an IV infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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] )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-55920839Also: CNTO 6358JNJ-55920839 will be administered as either IV infusion or subcutaneous injection. | Drug | 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 |
| Placebo0.9 percent (%) normal saline. | Drug | 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 |
Primary outcome
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.
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.
13 secondary outcomes
Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 130 after dose
Terminal half-life (T1/2) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after SC injection in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Bioavailability (F) after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B
Time frame: Up to Day 130 after dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 38273624Jordan 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.
- Derived from this study: PubMed 33085033Yao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-55920839 in people with Systemic Lupus Erythematosus and Healthy, run by Janssen Research & Development, LLC at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United States, Belgium, Poland, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609789, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.