Long-term study of APG777 for atopic dermatitis in people already treated with it
Tests APG777 long term in adults with atopic dermatitis who finished an earlier APG777 study.
Key facts
- Who runs it
- Apogee Therapeutics, Inc.
- Where
- Prague, CzechiaSee the siteAlso in 8 other countries, 70 sites
- Trial code
- Registry title
- A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 350 people, planned
- Started
- 14 May 2025
- Expected to end
- Dec 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- APG777
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atopic dermatitis who finished treatment in an earlier APG777 study and may benefit from continuing APG777 long term.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Moderate-to-severe atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study
- Earlier treatment
- Must have completed the Treatment Period in a prior APG777 study (Parent Study NCT06395948) and followed the study plan. Must use the same non-medicated moisturizer throughout the study.
Main reasons for not taking part
- Had a side effect in the Parent Study that could make continued APG777 treatment an unreasonable risk
- Left the Parent Study early or permanently stopped the study drug
- Uses any of the prohibited medications from the Screening Visit
- Has other skin conditions or illnesses that could confuse the AD diagnosis or interfere with study assessments
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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 take part
- 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
Where in Czechia
Also in 8 other countries, 70 sites
- PragueHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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 full original descriptionShow less
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.
The 3 groups in the trial
- APG777 - Long Term Extension Treatment - 12 WeeksTreatment being tested
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).
Treatment: APG777
- APG777 - Long Term Extension Treatment - 24 WeeksTreatment being tested
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).
Treatment: APG777
- APG777 - Open Label Escape ArmTreatment being tested
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.
Treatment: APG777
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
- Plain-language title
- Long-term study of APG777 for atopic dermatitis in people already treated with itGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026