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

• Register: EUCTR
• Last refreshed on: 22 November 2021
• Main ID: EUCTR2019-003323-38-PL
• Date of registration: 07/10/2020
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly & Company
• Public title: A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE
• Date of first enrolment: 09/10/2020
• Target sample size: 280
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003323-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Canada, Czechia, Germany, Hungary, India, Israel, Japan, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly & Company

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly & Company

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: LY3471851
Product Code: LY3471851
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not applicable
CAS Number: 820247-07-2
Current Sponsor code: Product 52
Other descriptive name: LY3471851
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

Primary end point(s): The primary comparison of interest is the difference in proportion of participants who achieve SLEDAI-4 response at Week 24.

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.

Secondary Objective: ? To determine whether treatment with LY3471851 Q2W is superior to placebo in reducing other measures of signs and symptoms of SLE

Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome(s)

Secondary end point(s): Secondary comparisons of interest are the difference in proportion of participants who at Week 24 achieve:
? BILAG-based Composite Lupus Assessment (BICLA) response
? SRI-4 response
? Lupus Low Disease Activity State (LLDAS)

Secondary objectives will be assessed using a composite estimand (as described above).

Timepoint(s) of evaluation of this end point: Week 24

Secondary ID(s)

2019-003323-38-DE

J1P-MC-KFAJ

Source(s) of Monetary Support

Eli Lilly & Company

Ethics review

Status: Approved
Approval date: 23/09/2020
Contact: