A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus (LAVENDER)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Cutaneous Lupus Erythematosus

Treatments: Combination Product: Anifrolumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06015737

2021-003698-70 (EudraCT Number)

D346BC00001

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).

Full description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in adults with chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The study has a randomized, 24-week double-blind, placebo-controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of anifrolumab. The double-blind study period will be followed by an open-label, uncontrolled treatment period in which all participants will receive treatment with anifrolumab from Week 24 to Week 51. After the open-label treatment period, participants will enter a 12-week Safety Follow-up Period.

Enrollment: 302 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:

  • CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
  • Inadequate response or intolerant to antimalarial therapy.

• Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.

• Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key exclusion criteria:

• History or evidence of suicidal ideation.
• Severe or life-threatening Systemic lupus erythematosus (SLE).
• Active SLE or Sjögren's Syndrome.
• Any active skin conditions other than CLE that may interfere with the study.
• History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
• History of recurrent infection requiring hospitalization and IV antibiotics.
• COVID-19 infection.
• Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
• At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups, including a placebo group

Anifrolumab

Experimental group

Description:

Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51.

Treatment:

Combination Product: Anifrolumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo as a SC injection from Week 0/Day 1 up to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.

Treatment:

Other: Placebo