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NCT Number: NCT06015737

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cutaneous Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ciudad de Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anifrolumab

Combination Product

Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Placebo

Other

Matching placebo solution for injection in aPFS.

Primary outcomes

  1. Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score

    Time frame: At Week 24

    The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.

Secondary outcomes

  1. Change from baseline in total CLASI-A score

    Time frame: At Week 24

    The CLASI-A is a validated index used for assessing the cutaneous lesions of SLE.

  2. Number of participants with CLASI-70 response

    Time frame: At Week 12

    The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.

  3. Number of participants with ≥ 7-point reduction from baseline in CLASI-A total score

    Time frame: At Week 12

    The CLASI is a validated index used for assessing the cutaneous lesions of SLE. A 7-point reduction CLASI-A is established as clinically meaningful improvement in disease for CLE and as being impactful for patients.

  4. Number of participants with CLASI-50 response

    Time frame: At Week 12 and Week 24

    The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-50 responder is defined as a responder (yes/no) is defined as a participant who achieves at least a 50% reduction relative to baseline in CLASI-A score. Otherwise, the participant is a non-responder.

  5. Number of participants who are sustained CLASI-70 responders

    Time frame: Up to Week 52

    The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder. Amongst participants randomized to anifrolumab, the number of participants who maintained a CLASI-70 response from Week 24 up to Week 52 will be evaluated.

  6. Serum trough (pre-dose) concentrations of anifrolumab

    Time frame: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose)

    The Ctrough of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.

  7. Number of participants with positive antidrug antibody

    Time frame: Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose)

    The immunogenicity of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.

  8. Percent change from baseline in suppression of the Interferon 21-gene

    Time frame: Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose)

    The pharmacodynamics of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.

  9. Change from baseline in Skindex-29+3 Symptom domain scores

    Time frame: At Week 24

    The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE. The instrument consists of 33 items, which are used to calculate 4 domains: Symptoms (7 items), Emotions (10 items), Functioning (12 items), and Lupus-specific (3 items). The remaining item asks the participants to rate how often they worry about side effects from treatment; however, this item is not used to calculate the domain scores. The response options are on a 5-point verbal rating scale, ranging from 1 (Never) to 5 (All the time). The instrument has a recall period of the previous 4 weeks. Each domain score ranges from 0 to 100 points, with higher scores indicating worse health-related quality of life.

  10. Change from baseline in Skindex-29+3 Emotion domain scores

    Time frame: At Week 24

    The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.

  11. Change from baseline in Skindex-29+3 Function domain scores

    Time frame: At Week 24

    The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.

  12. Change from baseline in Skindex-29+3 Lupus-Specific domain scores

    Time frame: At Week 24

    The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.

  13. Change from baseline in Skindex-29+3 Total score

    Time frame: At Week 24

    The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE.

  14. Time from IP start date to CLASI-70 response.

    Time frame: From Week 0/Day 1 up to Week 24

    To assess the efficacy of anifrolumab compared with placebo on the onset of reduction in skin manifestations in participants with chronic and/or subacute CLE.

  15. Time from IP start date to CLASI-50 response.

    Time frame: From Week 0/Day 1 up to Week 24

    To assess the efficacy of anifrolumab compared with placebo on the onset of reduction in skin manifestations in participants with chronic and/or subacute CLE.

Other outcomes

  1. Number of participants with adverse events

    Time frame: Screening (up to and including 42 days before Day 1) until Safety Follow-up Period (12 weeks from Week 52/EDV)

    To evaluate the safety and tolerability of anifrolumab compared with placebo in participants with CLE.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

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 Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy.

Acronym: LAVENDER

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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