Trials Today

A Study Evaluating APG777 in Atopic Dermatitis

Purpose

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 (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. 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.

Condition

Atopic Dermatitis

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit - Moderate-to-severe AD at Screening and Baseline visits - History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable - Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits. - Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit

Exclusion Criteria

Participation in a prior study with APG777. - Prior treatment with protocol-specified monoclonal antibodies (mAbs) - Has used any AD-related topical medications within 7 days prior to Baseline visit. - Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit Note: Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The Sponsor's study staff will also be blinded in the study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Induction Period: APG777	Participants will receive APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Placebo Comparator Part A: Induction Period: Placebo	Participants will receive matching Placebo injections per protocol defined dosing regimen	Drug: Placebo Matching placebo subcutaneous injection
Experimental Part A: Maintenance Period: APG777	Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Experimental Part B: Induction Period: APG777	Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Placebo Comparator Part B: Induction Period: Placebo	Participants will receive matching placebo injections per protocol defined dosing regimen	Drug: Placebo Matching placebo subcutaneous injection
Experimental Part B: Maintenance Period: APG777	Participants will receive APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection

Recruiting Locations

Investigational Site #14
Fountain Valley, California 92708

Investigational Site # 46
Los Angeles, California 90024

Investigational Site # 8
San Diego, California 92123

Investigational Site # 44
New Haven, Connecticut 06519

Investigational Site # 1
Coral Gables, Florida 33134

Investigational site #48
Jacksonville, Florida 32256

Investigational Site # 21
Margate, Florida 33063

Investigational site #47
Douglasville, Georgia 30135

Investigational Site # 36
Skokie, Illinois 60077

Investigational Site # 38
West Lafayette, Indiana 47906

Investigational site #50
Bowling Green, Kentucky 42104

Investigational Site # 2
Rockville, Maryland 20850

Investigational Site # 43
Detroit, Michigan 48202

Investigational Site #10
Troy, Michigan 48084

Investigational Site #16
Portsmouth, New Hampshire 13801

Investigational site #49
New York, New York 10023

Investigational Site # 3
Wilmington, North Carolina 28403

Investigational Site # 31
Boardman, Ohio 44512

Investigational Site #12
Mason, Ohio 45040

Investigational Site #22
Portland, Oregon 97201

Investigational Site # 34
Pittsburgh, Pennsylvania 15213

Investigational Site # 37
Charleston, South Carolina 29425

Investigational Site # 4
Nashville, Tennessee 37215

Investigational Site # 23
Dallas, Texas 75230

Investigational Site # 33
Dallas, Texas 75235

Investigational Site # 18
San Antonio, Texas 78213

Investigational Site # 5
Norfolk, Virginia 23502

Investigational Site # 7
Mill Creek, Washington 98012

More Details

NCT ID: NCT06395948
Status: Recruiting
Sponsor: Apogee Therapeutics, Inc.

Study Contact

Study Director
+1 781 208 2408
ClinicalTrials@apogeetherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.