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Monoclonal Antibodies
Anifrolumab for Skin Lupus (LAVENDER Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection reflected in chest radiograph or a chest CT scan result
Participants must have a confirmed diagnosis of CLE clinically and histologically
Must not have
Severe or life-threatening Systemic lupus erythematosus (SLE)
History of recurrent infection requiring hospitalization and IV antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)
Awards & highlights
Pivotal Trial
Summary
"This trial will test if an injection called anifrolumab is better than a placebo for treating skin lupus in adults."
Who is the study for?
Adults with chronic or subacute cutaneous lupus erythematosus who haven't responded well to anti-malarial therapy or other medications like topical calcineurin inhibitors, systemic glucocorticoids, or immunosuppressants. They must not have a history of tuberculosis and should test negative for COVID-19. Women must follow local cervical cancer screening guidelines.
What is being tested?
The trial is testing the effectiveness and safety of Anifrolumab, administered under the skin, compared to a placebo in adults with cutaneous lupus erythematosus. Participants will be randomly assigned to receive either Anifrolumab or a placebo.
What are the potential side effects?
Possible side effects of Anifrolumab may include respiratory tract infections, herpes zoster, headaches, infusion-related reactions (like pain at injection site), and potential increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had tuberculosis, as confirmed by chest scans.
Select...
My CLE diagnosis is confirmed by clinical and tissue examination.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lupus is severe or life-threatening.
Select...
I have been hospitalized for infections needing IV antibiotics.
Select...
I have active lupus or Sjögren's Syndrome.
Select...
I have been infected with COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stage 1 and Stage 2 (European Union [EU]/Rest of the World [ROW]: Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
Stage 1 and Stage 2 (United States [US]): Number of participants with Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0 or 1 and at least a 2- point reduction relative to baseline
Secondary study objectives
Stage 1 and Stage 2 (EU/ROW): Number of participants with CLASI-70 response
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score
+13 moreOther study objectives
Stage 1 and Stage 2 (US, EU and ROW): Number of participants with adverse events
Side effects data
From 2018 Phase 3 trial • 373 Patients • NCT0244689923%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Lip squamous cell carcinoma
1%
Cervical dysplasia
1%
Angioedema
1%
Hypoaesthesia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2: AnifrolumabExperimental Treatment1 Intervention
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Group II: Stage 1: AnifrolumabExperimental Treatment1 Intervention
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Group III: Stage 2: PlaceboPlacebo Group1 Intervention
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Group IV: Stage 1: PlaceboPlacebo Group1 Intervention
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,326 Total Patients Enrolled
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,484 Total Patients Enrolled