Lupus Erythematosus, SystemicPhase 1NCT03933943
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
A Phase 1 study testing LY3361237 in people with Lupus Erythematosus, Systemic, run by Eli Lilly and Company at 9 sites in United States.
Trial summary
The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- LY3361237
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 May 2019to 15 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology [ACR] classification)
- If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks
- If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:
- Azathioprine ≤200 mg/day
- Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine)
- Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day)
- Oral, SC, or intramuscular methotrexate ≤15 milligrams per week (mg/week)
Who cannot join
- Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE
- Participants must not have a current active bacterial, viral, or fungal infection
- Participants must not have evidence of significant liver or kidney dysfunction
- Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months.
- Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months
- Participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Pinnacle Research Group
Anniston, Alabama, 36207
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210
Clinical Research of West Florida
Clearwater, Florida, 33765
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Accurate Clinical Management LLC - Katy
Houston, Texas, 77084
West Tennessee Research Institute
Jackson, Tennessee, 38305
North Georgia Rheumatology, PC
Lawrenceville, Georgia, 30046
Paramount Medical Research
Middleburg Heights, Ohio, 44130
Clinical Research of West Florida
Tampa, Florida, 33606
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus
The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- LY3361237, 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.
LY3361237Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3361237 | Experimental | LY3361237 administered subcutaneously (SC) Receives: Drug: LY3361237 |
| Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Day 155
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
PK: Cmax of LY3361237
Measured: Day 1 predose through Day 155
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
PK: AUC Over the Dosing Interval of LY3361237
Measured: Day 1 predose through Day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start21 May 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
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 Eli Lilly and CompanyThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933943
- Sponsor's protocol ID
- 17180
- Other IDs
- I9S-MC-BTAB
- Status last verified
- 1 Mar 2021
- First submitted
- 30 Apr 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03933943
- Acronym / sponsor ID
- 17180
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 1 May 2019 (actual)
- 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 main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3361237 | Experimental | Drug: LY3361237LY3361237 administered subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology [ACR] classification)
- If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks
- If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:
Key exclusion criteria (6 listed)
- Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE
- Participants must not have a current active bacterial, viral, or fungal infection
- Participants must not have evidence of significant liver or kidney dysfunction
- Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months.
- Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months
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 |
|---|---|---|
| LY3361237Administered SC | Drug | LY3361237 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame: Baseline through Day 155
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
Time frame: Day 1 predose through Day 155
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
Time frame: Day 1 predose through Day 155
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 4 Mar 2021.
- A Study of LY3361237 in Participants With Systemic Lupus ErythematosusLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
9 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 LY3361237 in people with Lupus Erythematosus, Systemic, run by Eli Lilly and Company at 9 sites in United States.
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 6 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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. Some participants in this study may receive a placebo. 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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug (time frame: Baseline through Day 155). 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 4 Mar 2021.