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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07027527




Registration number
NCT07027527
Ethics application status
Date submitted
11/06/2025
Date registered
18/06/2025
Date last updated
16/07/2025

Titles & IDs
Public title
An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
Scientific title
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
Secondary ID [1] 0 0
APG279-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APG777
Treatment: Drugs - APG990
Treatment: Drugs - Dupilumab

Experimental: APG777 + APG990 - Participants will receive protocol specified combination dose of APG777 + APG990

Active comparator: Dupilumab - Participants will receive protocol specified dose of Dupilumab


Treatment: Drugs: APG777
Subcutaneous (SC) injection

Treatment: Drugs: APG990
SC injection

Treatment: Drugs: Dupilumab
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Predose Serum Concentrations (Ctrough) of APG777
Timepoint [1] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcome [2] 0 0
Predose Serum Concentrations (Ctrough) of APG990
Timepoint [2] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcome [3] 0 0
Maximum Serum Concentrations (Cmax) of APG777
Timepoint [3] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcome [4] 0 0
Maximum Serum Concentrations (Cmax) of APG990
Timepoint [4] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcome [5] 0 0
Time to Reach Cmax (tmax) of APG777
Timepoint [5] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Secondary outcome [6] 0 0
Time to Reach Cmax (tmax) of APG990
Timepoint [6] 0 0
Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

Eligibility
Key inclusion criteria
Inclusion Criteria

* Have a diagnosis of AD that has been present for = 1 year prior to the Screening visit and as determined by the Investigator through participant interview and/or review of the medical history.
* Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of = 16, b) vIGA-AD score of = 3, and c) AD affecting =10% of body surface area (BSA).
* History of inadequate response to treatment with topical medications
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participation in a prior study with APG777 or APG990.
* 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
* History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab.
* Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Skin and Cancer Foundation Australia - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists Pty Ltd. - Kogarah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Skin Health Institute - Carlton
Recruitment hospital [5] 0 0
Dr Rodney SInclair Pty Ltd - East Melbourne
Recruitment hospital [6] 0 0
Melbourne Health - Parkville
Recruitment hospital [7] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
New Zealand
State/province [3] 0 0
Waitako
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Apogee Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
+1 781 208 2408
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07027527