Lupus Erythematosus, SystemicPhase 1NCT02920424
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing JNJ-56022473 in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 3 sites in Germany.
Trial summary
The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- JNJ-56022473
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- 30 Jun 2017to 26 Sep 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
- Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration
- Have a positive gene signature score during screening, prior to first administration of study agent
- Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication:
- oral corticosteroids equivalent to an average dose up to or equal to (<=) 10 milligram (mg) of prednisone/day
- use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
- maximum of 1 non-corticosteroid immunosuppressive drug
Who cannot join
- Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE)
- Subject has unstable lupus nephritis and/ or 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
- Major surgery prior to, and, if planned, during and shortly after the study is not eligible
- Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit
- Any other inflammatory diseases that might confound the evaluations of efficacy are excluded
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité Research Organisation GmbH
Berlin, 10117
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- JNJ-56022473, Placebo
- 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-56022473Drug
Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
PlaceboDrug
Subjects will receive matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part A: JNJ-56022473 or Placebo (4:1) | Experimental | Subjects will receive 3 subcutaneous (SC) administrations of the same dose level of JNJ-56022473 Dose 1, Dose 2, or Dose 3 or placebo every 2 weeks (in the ratio of 4:1 [4 active: 1 placebo]). Receives: Drug: JNJ-56022473; Drug: Placebo |
| Part B: JNJ-56022473 or Placebo (5:1) | Experimental | Subjects will receive 3 SC administrations of the same dose level of JNJ-56022473 or placebo every 2 weeks (in the ratio of 5:1 [5 active: 1 placebo]). The dose level(s) will be based upon an interim analysis (IA) of the Part A data. Receives: Drug: JNJ-56022473; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
Measured: Up to 16 weeks
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
Measured: Up to 16 weeks
Secondary outcomes (4)
Serum Concentration of JNJ-56022473
Measured: Up to 16 weeks
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
Measured: Up to 16 weeks
Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)
Whole blood samples collected from subjects enrolled in this study will be examined by qPCR to assess the ability of JNJ-56022473 to initiate the expected effect on target cells.
Measured: Up to 38 weeks
Counts of Target Cells
Counts of target cells will be measured by flow cytometry from whole blood.
Measured: Up to 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start30 Jun 2017 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion26 Sep 2019 (estimated)
Why it stopped: The decision is based on a change in the benefit risk assessment of this drug for the lupus population targeted in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- 0 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
- NCT02920424
- Sponsor's protocol ID
- CR108216
- Other IDs
- 2016-001260-11, 56022473SLE1001, 2016
- Status last verified
- Nov 2017
- First submitted
- 29 Sep 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02920424
- Acronym / sponsor ID
- CR108216
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The decision is based on a change in the benefit risk assessment of this drug for the lupus population targeted in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 26 Sep 2019 (estimated)
- First posted
- 30 Sep 2016 (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-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: JNJ-56022473 or Placebo (4:1) | Experimental | Drug: JNJ-56022473, Drug: PlaceboSubjects will receive 3 subcutaneous (SC) administrations of the same dose level of JNJ-56022473 Dose 1, Dose 2, or Dose 3 or placebo every 2 weeks (in the ratio of 4:1 [4 active: 1 placebo]). |
| Part B: JNJ-56022473 or Placebo (5:1) | Experimental | Drug: JNJ-56022473, Drug: PlaceboSubjects will receive 3 SC administrations of the same dose level of JNJ-56022473 or placebo every 2 weeks (in the ratio of 5:1 [5 active: 1 placebo]). The dose level(s) will be based upon an interim analysis (IA) of the Part A data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
- Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration
- Have a positive gene signature score during screening, prior to first administration of study agent
- Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication:
Key exclusion criteria (5 listed)
- Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE)
- Subject has unstable lupus nephritis and/ or 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
- Major surgery prior to, and, if planned, during and shortly after the study is not eligible
- Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit
- Any other inflammatory diseases that might confound the evaluations of efficacy are excluded
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-56022473Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels. | Drug | Part A: JNJ-56022473 or Placebo (4:1), Part B: JNJ-56022473 or Placebo (5:1) |
| PlaceboSubjects will receive matching placebo. | Drug | Part A: JNJ-56022473 or Placebo (4:1), Part B: JNJ-56022473 or Placebo (5:1) |
Primary outcome
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
Time frame: Up to 16 weeks
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
Time frame: Up to 16 weeks
4 secondary outcomes
Serum Concentration of JNJ-56022473
Time frame: Up to 16 weeks
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
Time frame: Up to 16 weeks
Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)
Time frame: Up to 38 weeks
Counts of Target Cells
Time frame: Up to 38 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-56022473 in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 3 sites in Germany.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16 (time frame: Up to 16 weeks). 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?
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 27 Nov 2017.