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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks to 52 weeks for reporting.

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 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Apogee Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of participants enlisting in this medical study?

"Yes, the information available on clinicaltrials.gov indicates that recruitment is ongoing for this particular study. The trial was first listed on April 29th, 2024 and had its most recent update on the same date. Researchers aim to enroll a total of 471 participants from one designated site."

Answered by AI

What are the risks associated with Part A: Induction Period: APG777 for individuals?

"In the initial phase of this trial, denoted as Part A: Induction Period involving APG777, our team at Power has rated its safety a 2. This rating indicates there is existing safety data but no evidence yet that supports efficacy."

Answered by AI

Is the enrollment process currently in progress for participants of this research study?

"As per the details on clinicaltrials.gov, this particular study is actively seeking individuals to enroll. The trial was initially listed on April 29th, 2024, and last modified on the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating APG777 in Atopic Dermatitis

2024. "A Study Evaluating APG777 in Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06395948.

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