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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 below

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I have never had tuberculosis, as confirmed by chest scans.

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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:

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My lupus is severe or life-threatening.

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I have been hospitalized for infections needing IV antibiotics.

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I have active lupus or Sjögren's Syndrome.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (up to and including 42 days before day 1) until safety follow-up period (13 weeks from week 52/ edv) for reporting.

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 more

Other 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 • NCT02446899

23%

Upper respiratory tract infection

16%

Nasopharyngitis

14%

Infusion related reaction

13%

Bronchitis

12%

Urinary tract infection

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Lip squamous cell carcinoma

Cervical dysplasia

Angioedema

Hypoaesthesia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met