Home › Trials › NCT06015737

Evaluating Anifrolumab for Skin Symptoms in Adults with Cutaneous Lupus Erythematosus

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

Phase 3 Interventional AstraZeneca · NCT06015737

This study tests if a new medication called anifrolumab can help adults with skin symptoms from cutaneous lupus erythematosus who haven't found relief with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsanifrolumab
Locations270 sites (Glendale, Arizona and 269 other locations)
Trial IDNCT06015737 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of anifrolumab, a medication administered subcutaneously, compared to a placebo in adults suffering from chronic and/or subacute cutaneous lupus erythematosus (CLE). The primary goal is to assess how well anifrolumab reduces skin disease in participants who have not responded adequately to antimalarial treatments. The study is designed in two stages, both featuring a randomized, double-blind, placebo-controlled approach, followed by an open-label treatment phase. Secondary objectives include evaluating additional efficacy measures, safety, quality of life, and pharmacokinetics.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of cutaneous lupus erythematosus who have not responded to or are intolerant of antimalarial therapy.

Not a fit: Patients with a history of suicidal ideation or severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin symptoms and quality of life for patients with cutaneous lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific investigation into anifrolumab for CLE is novel.

Eligibility criteria

Show full inclusion / 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.
  * CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 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.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

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 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

Where this trial is running

Glendale, Arizona and 269 other locations

+220 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cutaneous Lupus ErythematosusLupus erythematosusCutaneous lupus erythematosusAnifrolumabCutaneous Lupus Erythematosus Disease Area Severity IndexCutaneous lupus activity - Investigator's Global Assessment - Revised
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.