Study identifier:D346BC00001
ClinicalTrials.gov identifier:NCT06015737
EudraCT identifier:2021-003698-70
CTIS identifier:2023-503692-24-00
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
Cutaneous lupus erythematosus
Phase 3
No
Anifrolumab
All
460
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Stage 1: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51. | Combination Product: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). |
Placebo Comparator: Stage 1: Placebo The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51. | Other: Placebo Matching placebo solution for injection in aPFS. |
Experimental: Stage 2: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51. | Combination Product: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). |
Placebo Comparator: Stage 2: Placebo The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51. | Other: Placebo Matching placebo solution for injection in aPFS. |