A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

Date Added
September 3rd, 2024
PRO Number
Pro00137485
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A TWO-PART, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
September 6th, 2024
PRO Number
Pro00136714
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of APG777 in adult patients with moderate-to-severe atopic dermatitis. Part A will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. Both parts (Part A and Part B) will consist of 4 periods:
o Screening Period of up to 6 weeks
o Induction Period of up to approximately 16 weeks
o Maintenance Period of up to approximately 36 weeks
o Post-treatment Follow-up Period

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu



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