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

Conditions

Cutaneous Lupus Erythematosus

Brief summary

Number of participants with CLASI-70 response at Week 24.

Detailed description

Total CLASI A score, change from baseline at Week 24., - Number of participants with CLASI-70 response at Week 12. - Participants with ≥ 7 point reduction from baseline in CLASI A total score (yes/no) at Week 12. - Number of participants with CLASI 50 response at Week 12., Change from baseline at Week 24 in Skindex-29+3 domain scores., - Time from IP start date to CLASI 70 response; - Time from IP start date to CLASI 50 response., Number of participants with CLASI 50 response at Week 24., Number of participants who are primary endpoint responders (CLASI-70 response at Week 24) and sustain CLASI-70 response up to and including Week 52., - Pharmacokinetic (PK) assessment (Ctrough) for subcutaneously administered anifrolumab in participants with CLE will be performed., - Pharmacodynamic (PD) assessment for subcutaneously administered anifrolumab in participants with CLE will be performed., - The immunogenicity of subcutaneously administered anifrolumab in participants with CLE will be evaluated., Number of participants with adverse events.

Related papers

No related papers found yet.

Interventions

DRUGAnifrolumab

DRUGMatching placebo solution for injection in aPFS; 0.8 mL fill volume

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants with CLASI-70 response at Week 24.	—

Secondary

Measure	Time frame
Total CLASI A score, change from baseline at Week 24., - Number of participants with CLASI-70 response at Week 12. - Participants with ≥ 7 point reduction from baseline in CLASI A total score (yes/no) at Week 12. - Number of participants with CLASI 50 response at Week 12., Change from baseline at Week 24 in Skindex-29+3 domain scores., - Time from IP start date to CLASI 70 response; - Time from IP start date to CLASI 50 response., Number of participants with CLASI 50 response at Week 24., Number of participants who are primary endpoint responders (CLASI-70 response at Week 24) and sustain CLASI-70 response up to and including Week 52., - Pharmacokinetic (PK) assessment (Ctrough) for subcutaneously administered anifrolumab in participants with CLE will be performed., - Pharmacodynamic (PD) assessment for subcutaneously administered anifrolumab in participants with CLE will be performed., - The immunogenicity of subcutaneously administered anifrolumab in participants with CLE will be eva	—

Measure

Time frame

Total CLASI A score, change from baseline at Week 24., - Number of participants with CLASI-70 response at Week 12. - Participants with ≥ 7 point reduction from baseline in CLASI A total score (yes/no) at Week 12. - Number of participants with CLASI 50 response at Week 12., Change from baseline at Week 24 in Skindex-29+3 domain scores., - Time from IP start date to CLASI 70 response; - Time from IP start date to CLASI 50 response., Number of participants with CLASI 50 response at Week 24., Number of participants who are primary endpoint responders (CLASI-70 response at Week 24) and sustain CLASI-70 response up to and including Week 52., - Pharmacokinetic (PK) assessment (Ctrough) for subcutaneously administered anifrolumab in participants with CLE will be performed., - Pharmacodynamic (PD) assessment for subcutaneously administered anifrolumab in participants with CLE will be performed., - The immunogenicity of subcutaneously administered anifrolumab in participants with CLE will be eva

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Countries

Austria, Bulgaria, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed