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Long-term safety and effectiveness of APG777 in moderate-to-severe atopic dermatitis

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

Phase 2 Interventional Apogee Therapeutics, Inc. · NCT07003425

This long-term extension will see if continued APG777 is safe and helpful for people with moderate-to-severe atopic dermatitis who completed a prior APG777 study.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years and up
SexAll
SponsorApogee Therapeutics, Inc. Industry-sponsored
Locations45 sites (Fountain Valley, California and 44 other locations)
Trial IDNCT07003425 on ClinicalTrials.gov

What this trial studies

This multicenter, double-blind long-term extension enrolls participants who completed the treatment period in a prior APG777 parent study and who may benefit from continued therapy. The LTE includes a screening visit coinciding with the last maintenance visit of the parent study, an extended treatment period where participants continue APG777, and a post-treatment follow-up period. Participants continue the same non-prescription emollient they used in the parent study and are monitored for safety and efficacy outcomes and adverse events. Those with serious adverse events or who discontinued the parent study early are excluded.

Who should consider this trial

Good fit: Ideal candidates are people with moderate-to-severe atopic dermatitis who completed the APG777 parent study treatment period and whom the investigator believes would benefit from continued treatment.

Not a fit: Patients who experienced adverse events on APG777, who terminated the parent study early, or who used prohibited medications are unlikely to benefit or be eligible for this extension.

Why it matters

Potential benefit: If successful, long-term APG777 could provide a safe, sustained treatment option that reduces symptoms and flare-ups for people with moderate-to-severe atopic dermatitis.

How similar studies have performed: Parent APG777 studies have completed treatment phases, but long-term extension data remain limited, so durable benefit and long-term safety are not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study

Exclusion Criteria:

* 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 in the Parent Study through 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 this trial is running

Fountain Valley, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisAPG777SafetyEfficacy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.