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APG777

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Apogee Therapeutics, Inc.|Last Updated: Jul 22, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment906
FDA Designations
No designations recorded
Clinical trial landscape

APG777 · 4 trials · 2 indications

Phase 2 2Phase 1 2
NCT07003425A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic DermatitisAtopic Dermatitis
RECRUITING350 Analytics
NCT06395948A Study Evaluating APG777 in Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING470 Analytics
PHASE2RECRUITING
A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study Evaluating APG777 in Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants with Treatment Emergent Adverse Events
Up to 3 years
Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Baseline and at Week 16
Part B: Proportion of participants who achieve EASI 75 at Week 16
At Week 16
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Up to 24 weeks
Number of Participants with Abnormal Laboratory Findings
Up to 52 weeks
Number of Participants with Abnormal Vital Signs
Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)
Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings
Up to 52 weeks
Secondary Endpoints
Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline
Through Extended Treatment Period, an average of 2 years
Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline.
Through Extended Treatment Period, an average of 2 years
Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline
Through Extended Treatment Period, an average of 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
APG777 - Long Term Extension Treatment - 12 WeeksEXPERIMENTALParticipants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
APG777 - Long Term Extension Treatment - 24 WeeksEXPERIMENTALParticipants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
APG777 - Open Label Escape ArmEXPERIMENTALParticipants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.
Part A: Induction Period: APG777EXPERIMENTALParticipants will receive APG777 per protocol defined dosing regimen
Part A: Induction Period: PlaceboPLACEBO_COMPARATORParticipants will receive matching Placebo injections per protocol defined dosing regimen
Part A: Maintenance Period: APG777EXPERIMENTALParticipants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
Part B: Induction Period: APG777EXPERIMENTALParticipants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
Part B: Induction Period: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo injections per protocol defined dosing regimen
Part B: Maintenance Period: APG777EXPERIMENTALParticipants will receive APG777 per protocol defined dosing regimen
APG777 + APG990EXPERIMENTALParticipants will receive protocol specified combination dose of APG777 + APG990
DupilumabACTIVE_COMPARATORParticipants will receive protocol specified dose of Dupilumab
APG777EXPERIMENTALParticipants will receive protocol specified dose of APG7777
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo
Interventions
NameTypeDescription
APG777DRUGAPG777 subcutaneous injection
PlaceboDRUGMatching placebo subcutaneous injection
APG990DRUGSC injection
DupilumabDRUGSC injection
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777 * Use the same non-pres...

Countries:United StatesCanadaCzechiaGermanyHungaryPolandSpainFranceUnited KingdomAustraliaNew Zealand
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT06395948lastUpdatePostDate: changed
LOWJul 22, 2026NCT06395948lastUpdatePostDate: changed
LOWJul 9, 2026NCT07003425lastUpdatePostDate: changed
LOWJul 9, 2026NCT07003425lastUpdatePostDate: changed
LOWJul 2, 2026NCT07003425lastUpdatePostDate: changed
LOWJul 2, 2026NCT07003425lastUpdatePostDate: changed
LOWJul 2, 2026NCT07003425lastUpdatePostDate: changed
LOWJul 2, 2026NCT07003425lastUpdatePostDate: changed
LOWJun 8, 2026NCT07003425lastUpdatePostDate: changed
LOWJun 8, 2026NCT07027527lastUpdatePostDate: changed
LOWJun 8, 2026NCT07003425lastUpdatePostDate: changed
LOWJun 8, 2026NCT07027527lastUpdatePostDate: changed
LOWJun 8, 2026NCT07003425lastUpdatePostDate: changed
LOWJun 8, 2026NCT07027527lastUpdatePostDate: changed
LOWMay 27, 2026NCT07003425lastUpdatePostDate: changed
LOWMay 27, 2026NCT07003425lastUpdatePostDate: changed
LOWMay 26, 2026NCT07003425primaryCompletionDate: changed
LOWMay 26, 2026NCT06395948primaryCompletionDate: changed
LOWMay 26, 2026NCT06920901primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT07027527Status: RECRUITING → ACTIVE_NOT_RECRUITING