NCT06015737

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-29
• Primary completion: 2026-11-13
• Completion: 2027-08-20
• First posted: 2023-08-29
• Last updated: 2026-03-11

Locations

272 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, 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

Regulatory

• FDA-regulated drug study