APG777
DrugSubcutaneous (SC) injection
NCT Number: NCT07027527
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Investigational Site, Darlinghurst, New South Wales, Australia
Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Additional protocol defined Inclusion/Exclusion criteria apply
Subcutaneous (SC) injection
SC injection
SC injection
Other names: Dupixent
Time frame: Up to 24 weeks
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Apogee Therapeutics, Inc.
Industry
A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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