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Monoclonal Antibodies

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial is testing a new drug to see if it is safe and effective in treating adults with Lupus.

Eligible Conditions
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Secondary study objectives
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
+1 more

Side effects data

From 2023 Phase 2 trial • 291 Patients • NCT04433585
16%
Injection site reaction
15%
Pyrexia
8%
Fatigue
7%
Arthralgia
7%
Nasopharyngitis
5%
Alanine aminotransferase increased
5%
Anaemia
5%
Injection site erythema
5%
Injection site pain
5%
Urinary tract infection
4%
Injection site pruritus
4%
Myalgia
4%
Asthenia
4%
Bronchitis
4%
COVID-19
4%
Gamma-glutamyltransferase increased
4%
Erythema
4%
Pruritus
3%
Pain in extremity
3%
Dyspepsia
3%
Heavy menstrual bleeding
3%
Injection site rash
3%
Headache
3%
Dermatitis contact
3%
Pain
3%
Back pain
3%
Pharyngitis
3%
Drug hypersensitivity
3%
Nausea
3%
Pityriasis rosea
3%
Injection site swelling
3%
Aspartate aminotransferase increased
3%
Influenza
3%
Rash
3%
Urticaria
1%
Nasal obstruction
1%
Dizziness
1%
Bundle branch block right
1%
Pharyngitis bacterial
1%
Groin pain
1%
Delusion
1%
Vertigo
1%
Memory impairment
1%
Application site reaction
1%
Injection site erosion
1%
Diarrhoea
1%
Erythema of eyelid
1%
Gastritis
1%
Dental caries
1%
Neck pain
1%
Skin infection
1%
Eosinophilia
1%
Mouth ulceration
1%
Sinusitis
1%
Chills
1%
Influenza like illness
1%
Hypotension
1%
Injection site exfoliation
1%
Oedema peripheral
1%
Eczema
1%
Nasal dryness
1%
Post procedural oedema
1%
Swelling face
1%
Dysuria
1%
Injection site hypersensitivity
1%
Localised oedema
1%
Dysaesthesia
1%
Pollakiuria
1%
Dry eye
1%
Myopia
1%
Ophthalmic migraine
1%
Feeling abnormal
1%
Joint dislocation
1%
Rash maculo-papular
1%
Lymphadenitis
1%
Furuncle
1%
Systemic lupus erythematosus
1%
Neutropenia
1%
Depression
1%
Haemorrhoids
1%
Cough
1%
Heart rate increased
1%
Thermal burn
1%
Post procedural complication
1%
Chest pain
1%
Rhinorrhoea
1%
Sensation of foreign body
1%
Arthritis
1%
Seasonal allergy
1%
Abdominal pain
1%
Oesophageal motility disorder
1%
Ligament sprain
1%
Iron deficiency anaemia
1%
Oropharyngeal pain
1%
Vomiting
1%
Fungal infection
1%
Otitis externa
1%
Upper respiratory tract infection
1%
Pyelonephritis
1%
COVID-19 pneumonia
1%
Rhinitis
1%
Oral candidiasis
1%
Viral infection
1%
Procedural pain
1%
Hypertension
1%
Urine protein/creatinine ratio increased
1%
Urinary sediment
1%
Limb injury
1%
Vaccination complication
1%
Hot flush
1%
Soft tissue injury
1%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
LY3471851 High Dose
LY3471851 Mid Dose
LY3471851 Low Dose
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3471851 Mid DoseExperimental Treatment1 Intervention
LY3471851 administered SC.
Group II: LY3471851 Low DoseExperimental Treatment1 Intervention
LY3471851 administered SC
Group III: LY3471851 High DoseExperimental Treatment1 Intervention
LY3471851 administered subcutaneously (SC).
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3471851
2021
Completed Phase 2
~670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,679 Previous Clinical Trials
3,465,462 Total Patients Enrolled
Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,025 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
427,877 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,281 Previous Clinical Trials
500,211 Total Patients Enrolled
~55 spots leftby Dec 2025
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