Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: LY3361237
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LY3361237
Other descriptive name: LY3361237
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Ages 18-65 years old? -Diagnosis of SLE for at least 24 weeks prior to screening? - Have documentation of having a total score of 10 or more points on EULAR/ACR 2019 classification criteria for SLE (Aringer et al. 2019) before randomization (Visit 2). -Positive ANA and/or positive anti-dsDNA and/or positive anti-Sm antibody test at screening? -SLEDAI-2k score of >/= 6 at screening? -Clinical SLEDAI-2k score of >/= 4 at randomization? -Have active arthritis and/or active rash as defined by the SLEDAI 2K at screening and at randomization.? Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Corticosteriod use:? -Current oral corticosteroid doses > 20mg per day or adjusted dosage within 2 weeks prior to randomization? -Received topical corticosteroids other than stable doses of Class VI or Class VII within 8 week before randomization? -Received parenteral corticosteroids within 12 weeks prior to randomization or are expected to require steroids during the study? Excluded conmeds? -Adjusted dose or addition of 2nd antimalarial (12 weeks)? -Adjusted dose or addition of 2nd immunosuppressant (12 weeks)? -Oral calcineurin inhibitor (4 weeks)? -JAK inhibitor (4 weeks)? -Adjusted steroid dose (2 weeks)? -Cyclophosphamide or other cytotoxic agent (12 weeks)? -Biologic therapies: rituximab, ocrelizumab or other B-cell-depleting agent (24 weeks), other biologic therapies (12 weeks)? -IV Ig (24 weeks)??
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of 450 mg LY3361237 every 2 weeks versus placebo with respect to arthritis and/or rash remission in participants with Systemic Lupus Erythematosus (SLE);Secondary Objective: To compare 450 mg LY3361237 every 2 weeks versus placebo with respect to SLE clinical signs and symptoms treatment response To characterize the pharmacokinetics (PK) of 450 mg LY3361237 every 2 weeks in participants with SLE ;Primary end point(s): Proportion of participants with arthritis and/or rash at baseline who achieve remission of arthritis and/or rash as defined by SLEDAI-2K at Week 24;Timepoint(s) of evaluation of this end point: Baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of participants who achieve SLEDAI-4 response at Week 24 - Proportion of participants who achieve SRI 4 response at Week 24 - Steady-state trough serum concentration of LY3361237 at Week 24 ;Timepoint(s) of evaluation of this end point: Baseline and 24 weeks | — |
Countries
Argentina, Czechia, Mexico, Poland, Puerto Rico, Russian Federation, Ukraine, United States
Contacts
Public ContactClinical Trials Registry Office
Eli Lilly
Outcome results
None listed