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

Date Added
January 6th, 2025
PRO Number
Pro00139544
Researcher
Kimberly Hashemi

List of Studies

Keywords
Lupus, Skin
Summary

This is a Phase III, multicenter, multinational, operationally seamless 2-stage study. The study will be conducted in 2 stages: Stage 1 and Stage 2. Participants will take part in either Stage 1 or Stage 2.Each stage has a randomized, 24-week double-blind, placebo controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of a SC treatment regimen of anifrolumab (120 mg, once weekly dosing) in adult participants with chronic and/or subacute CLE. The primary endpoint will be assessed at Week 24. The doubleblind, placebo-controlled study period of 24 weeks will be followed by an open-label, uncontrolled treatment period in which all participants will receive SC treatment with anifrolumab (120 mg, once weekly) from Week 24 to Week 51. After the open label treatment period, participants will enter a 12-week Safety Follow-up Period. The study will be performed in approximately 460 adult participants aged 18 to 70 years (inclusive). Stage 1 of the study is planned to be performed in approximately 100 participants (n ~ 50 per treatment arm). Stage 2 of the study is planned to be performed in approximately 360 participants (n ~ 180 per treatment arm).

Institution
MUSC
Recruitment Contact
Jordan Gertz
843-876-3209
gertzj@musc.edu

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Date Added
March 28th, 2025
PRO Number
Pro00141998
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This Phase 3, randomized, placebo-controlled, double-blind study evaluates the efficacy and safety of Upadacitinib in adults and adolescents with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy. The study includes a 35-day screening period, a 16-week placebo-controlled, double-blind treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3), and a 30-day follow-up period.

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu



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