A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus

Phase 1

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-003323-38-PL
• Lead Sponsor: Eli Lilly & Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

- Have received a clinical diagnosis of SLE at least 24 weeks before the screening visit (Visit 1).
- Have documentation of having met at least 4 of the 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 ACR (Tan et al. 1982; Hochberg 1997) before randomization.
- Have a positive ANA (titer =1:80) and/or a positive anti-dsDNA and/or positive anti-Sm antibody test at screening (Visit 1) as assessed by the central laboratory
- Have a SLEDAI-2K score =6 at screening (Visit 1) and clinical SLEDAI-2K score =4 at randomization (Visit 2).
- 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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Are currently receiving oral corticosteroids at doses >20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before randomization (Visit 2).
- Have received topical corticosteroids, other than stable doses of Class VI (mild, such as desonide) or Class VII (least potent, such as hydrocortisone), within 8 weeks before randomization (Visit 2).
- Have received parenteral (that is, intravenous or intramuscular) corticosteroids within 12 weeks before randomization (Visit 2) or are expected to require parenteral corticosteroids during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?To determine whether treatment with LY3471851 Q2W is superior to placebo in reducing the signs and symptoms of SLE as measured by SLEDAI-4;Secondary Objective: ?To determine whether treatment with LY3471851 Q2W is superior to placebo in reducing other measures of signs and symptoms of SLE;Primary end point(s): The primary comparison of interest is the difference in proportion of participants who achieve SLEDAI-4 response at Week 24.<br><br>The primary comparison will be assessed using a composite estimand where the intercurrent events of premature discontinuation and use of prohibited medication are part of the response definition.<br>;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary comparisons of interest are the difference in proportion of participants who at Week 24 achieve:<br>?BILAG-based Composite Lupus Assessment (BICLA) response<br>?SRI-4 response<br>?Lupus Low Disease Activity State (LLDAS)<br><br>Secondary objectives will be assessed using a composite estimand (as described above).;Timepoint(s) of evaluation of this end point: Week 24