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NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis

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
Apogee Therapeutics, Inc.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Atopic Dermatitis
Drug/Device/Intervention
APG777
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Apogee Therapeutics, Inc.
Location
San Diego,Coral Gables,Rockville,Troy,Wilmington,Nashville,Norfolk,Mill Creek,Markham,Montreal, Canada,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Apr 29, 2024
End date
Jun 01, 2028
Enrollment
471 participants
Primary outcome

Part A and B: Percent Change From Baseline in Eczema Area and Severity Index (EASI)

Summary

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants
 with moderate-to-severe Atopic Dermatitis (AD). 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. One maintenance regimen will be evaluated in Part B.
 The study duration for any individual participant will be up to 106 weeks which includes:
 screening, induction, maintenance, and post-treatment follow-up periods. Participants
 randomized in Part A are not permitted to participate in Part B.

ICD-10 classifications
Atopic dermatitisAtopic dermatitis, unspecifiedOther atopic dermatitisAcute atopic conjunctivitisAllergic contact dermatitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06395948
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06395948 through Pure Global AI's free database. This Phase 2 trial is sponsored by Apogee Therapeutics, Inc. and is currently Recruiting. The study focuses on Atopic Dermatitis. Target enrollment is 471 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.