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

NCT06015737 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2026-05-01

No results posted yet for this study

Summary

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).

Conditions

  • Cutaneous Lupus Erythematosus

Interventions

COMBINATION_PRODUCT

Anifrolumab

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

OTHER

Placebo

Matching placebo solution for injection in aPFS.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-29
Primary Completion
2026-12-11
Completion
2027-08-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015737 on ClinicalTrials.gov