Atopic DermatitisPhase 2NCT07003425
A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
A Phase 2 study testing APG777 in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 79 sites in 9 countries.
Trial summary
This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948). 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 79 sitesin 9 countries
- Study dates
- 14 May 2025to Dec 2029
- Phase
- Phase 2
- 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
- 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-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study
Who cannot join
- Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
- Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
- Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study
- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments
- Note: Additional protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
79 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 9 countries
United States23 sites, 23 recruiting
- Recruiting
Investigational Site
Boardman, Ohio, 44512
- Recruiting
Investigational Site
Bowling Green, Kentucky, 42101
- Recruiting
Investigational Site
Charleston, South Carolina, 29425
- Recruiting
Investigational Site
Coral Gables, Florida, 33134
- Recruiting
Investigational Site
Dallas, Texas, 75230
- Recruiting
Investigational Site
Detroit, Michigan, 48202
- Recruiting
Investigational Site
Douglasville, Georgia, 30135
- Recruiting
Investigational Site
Fountain Valley, California, 92708
- Recruiting
Investigational Site
Frisco, Texas, 75235
- Recruiting
Investigational Site
Jacksonville, Florida, 32256
- Recruiting
Investigational Site
Los Angeles, California, 90024
- Recruiting
Investigational Site
Margate, Florida, 33063
- Recruiting
Investigational Site
Mason, Ohio, 45040
- Recruiting
Investigational Site
Mill Creek, Washington, 98012
- Recruiting
Investigational Site
Nashville, Tennessee, 37215
- Recruiting
Investigational Site
New York, New York, 10023
- Recruiting
Investigational Site
Pittsburgh, Pennsylvania, 15213
- Recruiting
Investigational Site
Portland, Oregon, 97223
- Recruiting
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Rockville, Maryland, 20850
- Recruiting
Investigational Site
San Antonio, Texas, 78213
- Recruiting
Investigational Site
Skokie, Illinois, 60077
- Recruiting
Investigational Site
Troy, Michigan, 48084
- Recruiting
Investigational Site
Wilmington, North Carolina, 28403
Canada15 sites, 15 recruiting
- Recruiting
Investigational Site
Ajax, Ontario, L1S 7K8
- Recruiting
Investigational Site
Calgary, Alberta, T2J 7E1
- Recruiting
Investigational Site
Calgary, Alberta, T3E 0B2
- Recruiting
Investigational Site
Edmonton, Alberta, T5J 3S9
- Recruiting
Investigational Site
Fredericton, Brunswick, E3B 1G9
- Recruiting
Investigational Site
Markham, Ontario, L3P 1X3
- Recruiting
Investigational Site
Mississauga, Ontario, L4Y 4C5
- Recruiting
Investigational Site
Montreal, Quebec, H2X 2V1
- Recruiting
Investigational Site
Ottawa, Ontario, K1K 4L2
- Recruiting
Investigational Site
Peterborough, Ontario, K9J 5K2
- Recruiting
Investigational Site
Québec, Quebec, G1V 4X7
- Recruiting
Investigational Site
Toronto, Ontario, M3B 0A7
- Recruiting
Investigational Site
Toronto, Ontario, M4E 2Y9
- Recruiting
Investigational Site
Toronto, Ontario, M4W 2N4
- Recruiting
Investigational Site
Vancouver, British Columbia, V5Z 4E8
Germany13 sites, 13 recruiting
- Recruiting
Investigational Site
Augsburg, Bavaria, 86179
- Recruiting
Investigational Site
Bad Bentheim, Lower Saxony, 48455
- Recruiting
Investigational Site
Berlin, 10117
- Recruiting
Investigational Site
Blankenfelde-Mahlow, Brandenburg, 15831
- Recruiting
Investigational Site
Darmstadt, Hesse, 64283
- Recruiting
Investigational Site
Dresden, Saxony, 1307
- Recruiting
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Frankfurt am Main, Hesse, 60590
- Recruiting
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Hamburg, 20354
- Recruiting
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Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
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Kiel, Schleswig-Holstein, 24105
- Recruiting
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München, Bavaria, 80337
- Recruiting
Investigational Site
Münster, North Rhine Westfalia, 48149
- Recruiting
Investigational Site
Tübingen, Baden-Wurttemberg, 72076
Poland11 sites, 11 recruiting
- Recruiting
Investigational Site
Gdansk, Pomeranian Voivodeship, 80-546
- Recruiting
Investigational Site
Katowice, Silesian Voivodeship, 40-600
- Recruiting
Investigational Site
Krakow, Woj. Małopolskie, 30-727
- Recruiting
Investigational Site
Lodz, 90-237
- Recruiting
Investigational Site
Lublin, Lublin Voivodeship, 20-573
- Recruiting
Investigational Site
Sosnowiec, Silesian Voivodeship, 41-218
- Recruiting
Investigational Site
Szczecin, West Pomeranian Voivodeship, 71-500
- Recruiting
Investigational Site
Warsaw, Masovian Voivodeship, 01-595
- Recruiting
Investigational Site
Warsaw, Masovian Voivodeship, 02-482
- Recruiting
Investigational Site
Wroclaw, Lower Silesian Voivodeship, 50-450
- Recruiting
Investigational Site
Wroclaw, Lower Silesian Voivodeship, 51-503
Czechia5 sites, 5 recruiting
- Recruiting
Investigational Site
Prague, Prague, 128 00
- Recruiting
Investigational Site
Prague, Prague Motol, 150 06
- Recruiting
Investigational Site
Prague, Vinohrady, 100 34
- Recruiting
Investigational Site
Prague, 100 00
- Recruiting
Investigational Site
Prague, 16000
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site
Alicante, 3010
- Recruiting
Investigational Site
Badalona, Barcelona, 8916
- Recruiting
Investigational Site
Las Palmas de Gran Canaria, Canary Islands, 35010
- Recruiting
Investigational Site
Madrid, 28006
- Recruiting
Investigational Site
Santiago de Compostela, A Coruña, 15706
Hungary3 sites, 3 recruiting
- Recruiting
Investigational Site
Budapest, 1085
- Recruiting
Investigational Site
Debrecen, Hajdú-Bihar, 4032
- Recruiting
Investigational Site
Szeged, Csongrad-Csanad, 6720
United Kingdom3 sites, 3 recruiting
- Recruiting
Investigational Site
Dudley, West Midlands, DY2 1HQ
- Recruiting
Investigational Site
London, SE1 9RT
- Recruiting
Investigational Site
Salford, Greater Manchester, M6 8HD
About this study
Official title: A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.
- Conditions
- Atopic Dermatitis
- Being tested
- APG777
- Keywords
- Atopic Dermatitis, APG777, Safety, Efficacy
- 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
APG777 subcutaneous injection
APG777Drug
APG777 subcutaneous injection every 12 weeks
APG777Drug
APG777 subcutaneous injection every 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| APG777 - Long Term Extension Treatment - 12 Weeks | Experimental | Participants 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). Receives: Drug: APG777 |
| APG777 - Long Term Extension Treatment - 24 Weeks | Experimental | Participants 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). Receives: Drug: APG777 |
| APG777 - Open Label Escape Arm | Experimental | Participants 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. Receives: Drug: APG777 |
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
Measured: Up to 3 years
Secondary outcomes (10)
Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline
Measured: 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.
Measured: 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
Measured: Through Extended Treatment Period, an average of 2 years
Percentage of Participants who use Rescue Therapy
Measured: Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit EASI 75
Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined
Measured: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit vIGA-AD Response
Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.
Measured: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit I-NRS Response
Of the participants who achieve a ≥ 4 point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.
Measured: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs
Measured: Up to 3 years
Serum Concentrations of APG777 Over Time
Measured: Up to 3 years
Predose Serum Concentrations of APG777
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start14 May 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
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
- NCT07003425
- Sponsor's protocol ID
- APG777-202
- Status last verified
- Oct 2026
- First submitted
- 26 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
- ClinicalTrials.gov ID
- NCT07003425
- Acronym / sponsor ID
- APG777-202
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, APG777, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Apogee Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 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.
This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APG777 - Long Term Extension Treatment - 12 Weeks | Experimental | Drug: APG777Participants 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 Weeks | Experimental | Drug: APG777Participants 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 Arm | Experimental | Drug: APG777Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study
Key exclusion criteria (5 listed)
- Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
- Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
- Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study
- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments
- Note: Additional protocol defined Inclusion/Exclusion criteria may apply
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 |
|---|---|---|
| APG777APG777 subcutaneous injection | Drug | APG777 - Open Label Escape Arm |
| APG777APG777 subcutaneous injection every 12 weeks | Drug | APG777 - Long Term Extension Treatment - 12 Weeks |
| APG777APG777 subcutaneous injection every 24 weeks | Drug | APG777 - Long Term Extension Treatment - 24 Weeks |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 3 years
10 secondary outcomes
Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline
Time frame: 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.
Time frame: 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
Time frame: Through Extended Treatment Period, an average of 2 years
Percentage of Participants who use Rescue Therapy
Time frame: Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit EASI 75
Time frame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit vIGA-AD Response
Time frame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Percentage of Participants Who Continue to Exhibit I-NRS Response
Time frame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs
Time frame: Up to 3 years
Serum Concentrations of APG777 Over Time
Time frame: Up to 3 years
Predose Serum Concentrations of APG777
Time frame: Up to 3 years
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 22 Oct 2026.
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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.
ABBVIE INC. study director
AbbVie
79 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APG777 in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 79 sites in 9 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 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 79 sites in United States, Canada, Germany, Poland, Czechia and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.