A Study Evaluating APG777 in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395948
• Other study ID #: APG777-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 29, 2024
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: Apogee Therapeutics, Inc.
• Contact: Study Director
• Phone: +1 781 208 2408
• Email: ClinicalTrials[@]apogeetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 471
• Est. completion date: June 2028
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• APG777
APG777 subcutaneous injection
• Placebo
Matching placebo subcutaneous injection

Locations

Country	Name	City	State
Canada	Investigational site #15	Fredericton	New Brunswick
Canada	Investigational Site # 9	Markham	Ontario
Canada	Investigational Site # 6	Montreal	Quebec
Canada	Investigational Site #13	Peterborough	Ontario
Canada	Investigational Site #17	Québec	Quebec
Canada	Investigational Site #11	Toronto	Ontario
United States	Investigational Site # 1	Coral Gables	Florida
United States	Investigational Site #14	Fountain Valley	California
United States	Investigational Site #12	Mason	Ohio
United States	Investigational Site # 7	Mill Creek	Washington
United States	Investigational Site # 4	Nashville	Tennessee
United States	Investigational Site # 5	Norfolk	Virginia
United States	Investigational Site #16	Portsmouth	New Hampshire
United States	Investigational Site # 2	Rockville	Maryland
United States	Investigational Site # 18	San Antonio	Texas
United States	Investigational Site # 8	San Diego	California
United States	Investigational Site #10	Troy	Michigan
United States	Investigational Site # 3	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Apogee Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A and B: Percent Change From Baseline in Eczema Area and Severity Index (EASI)		Baseline and at Week 16
Secondary	Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to 106 Weeks
Secondary	Part A and B: Change from Baseline in EASI		Baseline, through Week 16 and at Week 52
Secondary	Part A and B: Percent Change from Baseline in EASI		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >= 2-Point Reduction		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Proportion of Participants Achieving a >= 4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS)		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS		Baseline through Week 16 and at Week 52
Secondary	Part A and B: Serum Concentrations of APG777 Over Time		Up to 106 Weeks
Secondary	Part A and B: Predose Serum Concentrations of APG777 (Ctrough)		Up to 106 Weeks
Secondary	Part A and B: Maximum concentration (Cmax) of APG777		Up to 106 Weeks
Secondary	Part A and B: Time to reach Cmax (tmax)		Up to 106 Weeks
Secondary	Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period		Baseline to 16 Weeks
Secondary	Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period		16 Weeks to 52 Weeks