Atopic DermatitisPhase 1NCT07027527
An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing APG777, APG990 and Dupilumab in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 20 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- APG777, APG990 and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 4 Jun 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Australia9 sites
Investigational Site
Carlton, Victoria, 3053
Investigational Site
Darlinghurst, New South Wales, 2010
Investigational Site
East Melbourne, Victoria, 3002
Investigational Site
Fremantle, Western Australia, 6160
Investigational Site
Kogarah, New South Wales, 2217
Investigational Site
Mitcham, Victoria, 3132
Investigational Site
Parkville, Victoria, 3050
Investigational Site
Westmead, New South Wales, 2145
Investigational Site
Woolloongabba, Queensland, 4102
Canada9 sites
Investigational Site
London, Ontario, N6H 5L5
Investigational Site
Montreal, Quebec, H1Y 3L1
Investigational Site
Peterborough, Ontario, K9J 5K2
Investigational Site
Québec, Quebec, G1W 1S2
Investigational Site
Richmond Hill, Ontario, L4B 1A5
Investigational Site
Sherbrooke, Quebec, J1G 1X9
Investigational Site
Toronto, Ontario, M4E 1R7
Investigational Site
Toronto, Ontario, M4W 2N4
Investigational Site
Toronto, Ontario, M5A 3R6
New Zealand2 sites
Investigational Site
Auckland, 1051
Investigational Site
Hamilton, Waitako, 3204
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Being tested
- APG777, APG990, Dupilumab
- Keywords
- Atopic Dermatitis, Moderate-to-Severe AD, APG777, Dupilumab, APG990
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG777Drug
Subcutaneous (SC) injection
APG990Drug
SC injection
DupilumabDrug
Also called Dupixent
SC injection
| Study group | Role | What they receive |
|---|---|---|
| APG777 + APG990 | Experimental | Participants will receive protocol specified combination dose of APG777 + APG990 Receives: Drug: APG777; Drug: APG990 |
| Dupilumab | Active comparator | Participants will receive protocol specified dose of Dupilumab Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 24 weeks
Secondary outcomes (6)
Predose Serum Concentrations (Ctrough) of APG777
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Predose Serum Concentrations (Ctrough) of APG990
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG777
PK parameters will be performed using a non-compartmental approach with a validated PK software
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG990
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG777
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.
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG990
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.
Measured: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start4 Jun 2025
- Primary completion29 Aug 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apogee Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027527
- Sponsor's protocol ID
- APG279-101
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim XQ, Winter E, Nograles K, Xu J, Zhang ZQ, Thankamony S, Dillinger L, Dambkowski CL. A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. Clin Transl Sci. 2025 Dec;18(12):e70456. doi: 10.1111/cts.70456.
PubMed 41422501
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07027527
- Acronym / sponsor ID
- APG279-101
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Moderate-to-Severe AD, APG777, Dupilumab, APG990
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Apogee Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APG777 + APG990 | Experimental | Drug: APG777, Drug: APG990Participants will receive protocol specified combination dose of APG777 + APG990 |
| Dupilumab | Active comparator | Drug: DupilumabParticipants will receive protocol specified dose of Dupilumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG777Subcutaneous (SC) injection | Drug | APG777 + APG990 |
| APG990SC injection | Drug | APG777 + APG990 |
| DupilumabAlso: DupixentSC injection | Drug | Dupilumab |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks
6 secondary outcomes
Predose Serum Concentrations (Ctrough) of APG777
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Predose Serum Concentrations (Ctrough) of APG990
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG777
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG990
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG777
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG990
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 41422501Lim XQ, Winter E, Nograles K, Xu J, Zhang ZQ, Thankamony S, Dillinger L, Dambkowski CL. A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. Clin Transl Sci. 2025 Dec;18(12):e70456. doi: 10.1111/cts.70456.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APG777, APG990 and Dupilumab in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07027527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.