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Monoclonal Antibodies
Part A: Maintenance Period: APG777 for Atopic Dermatitis
Phase 2
Recruiting
Research Sponsored by Apogee Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks to 52 weeks
Awards & highlights
Study Summary
This trial will test a new medication called APG777 for people with moderate-to-severe Atopic Dermatitis. The study has two parts: Part A will test the safety and effectiveness of different dos
Who is the study for?
This trial is for people with moderate-to-severe Atopic Dermatitis (AD), commonly known as eczema. Participants will be involved in the study for up to 106 weeks, which includes different phases such as screening and treatment follow-ups. Details on specific inclusion or exclusion criteria are not provided.Check my eligibility
What is being tested?
The trial is testing APG777 against a placebo to see if it's safe and effective for AD. It has two parts: Part A tests one induction dose regimen of APG777 and two maintenance regimens; Part B compares three dose regimens of APG777 with a placebo, including one maintenance regimen.See study design
What are the potential side effects?
Specific side effects are not listed, but generally, clinical trials look out for any adverse reactions ranging from mild symptoms like itching or redness at the application site to more serious systemic effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A and B: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Secondary outcome measures
Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period
Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period
Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement
+11 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Maintenance Period: APG777Experimental Treatment1 Intervention
Participants will receive APG777 per protocol defined dosing regimen
Group II: Part B: Induction Period: APG777Experimental Treatment1 Intervention
Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
Group III: Part A: Maintenance Period: APG777Experimental Treatment1 Intervention
Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
Group IV: Part A: Induction Period: APG777Experimental Treatment1 Intervention
Participants will receive APG777 per protocol defined dosing regimen
Group V: Part B: Induction Period: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo injections per protocol defined dosing regimen
Group VI: Part A: Induction Period: PlaceboPlacebo Group1 Intervention
Participants will receive matching Placebo injections per protocol defined dosing regimen
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Who is running the clinical trial?
Apogee Therapeutics, Inc.Lead Sponsor
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