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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: 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   
Address:  Lilly Corporate Center, DC 1526 IN 46285 Indianapolis United States
Telephone:
Email: EU_Lilly_Clinical_Trials@lilly.com
Affiliation:  Eli Lilly & Company
Name: Clinical Trial Registry Office   
Address:  Lilly Corporate Center, DC 1526 IN 46285 Indianapolis United States
Telephone:
Email: EU_Lilly_Clinical_Trials@lilly.com
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
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 23/09/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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