Clinical trial NCT03933943: A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. The study will last up to 26 weeks and may include up to 17 visits to the study center.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline through Day 155
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
timeFrame: Day 1 predose through Day 155
measure: PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
timeFrame: Day 1 predose through Day 155
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology, PC
state: Georgia
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Houston
country: United States
facility: Accurate Clinical Management LLC - Katy
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: