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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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22 November 2021 |
Main ID: |
EUCTR2019-003323-38-PL |
Date of registration:
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07/10/2020 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus
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Scientific title:
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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:
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09/10/2020 |
Target sample size:
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280 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003323-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Canada
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Czechia
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Germany
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Hungary
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India
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Israel
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Japan
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Korea, Republic of
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Mexico
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Poland
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Romania
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Russian Federation
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Spain
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
IN 46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly & Company |
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
IN 46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly & Company |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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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
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Primary Outcome(s)
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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
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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.
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Secondary Objective: ? To determine whether treatment with LY3471851 Q2W is superior to placebo in reducing other measures of signs and symptoms of SLE
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Outcome(s)
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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).
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary ID(s)
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2019-003323-38-DE
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J1P-MC-KFAJ
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Source(s) of Monetary Support
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Eli Lilly & Company
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Ethics review
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Status: Approved
Approval date: 23/09/2020
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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