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A Study Evaluating APG777 in Atopic Dermatitis - Trial NCT06395948

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.

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NCT06395948
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06395948
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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

Study Focus

Atopic Dermatitis

APG777

Interventional

drug

Sponsor & Location

Apogee Therapeutics, Inc.

San Diego,Coral Gables,Rockville,Troy,Wilmington,Nashville,Norfolk,Mill Creek,Markham,Montreal, Canada,United States of America

Timeline & Enrollment

Phase 2

Apr 29, 2024

Jun 01, 2028

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 dermatitis
Atopic dermatitis, unspecified
Other atopic dermatitis
Acute atopic conjunctivitis
Allergic contact dermatitis

Data Source

ClinicalTrials.gov

NCT06395948

Non-Device Trial