A Study Evaluating APG777 in Atopic Dermatitis

Description

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.

Conditions

Atopic Dermatitis

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Study Overview

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Study Details

Study overview

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.

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

A Study Evaluating APG777 in Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Investigational Site #14, Fountain Valley, California, United States, 92708

Los Angeles

Investigational Site # 46, Los Angeles, California, United States, 90024

San Diego

Investigational Site # 8, San Diego, California, United States, 92123

New Haven

Investigational Site # 44, New Haven, Connecticut, United States, 06519

Coral Gables

Investigational Site # 1, Coral Gables, Florida, United States, 33134

Margate

Investigational Site # 21, Margate, Florida, United States, 33063

Skokie

Investigational Site # 36, Skokie, Illinois, United States, 60077

West Lafayette

Investigational Site # 38, West Lafayette, Indiana, United States, 47906

Rockville

Investigational Site # 2, Rockville, Maryland, United States, 20850

Detroit

Investigational Site # 43, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Apogee Therapeutics, Inc.,

Study Record Dates

2028-06