NCT07003425 A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
| NCT ID | NCT07003425 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Apogee Therapeutics, Inc. |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 350 participants in total. It began in 2025-05-14 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility 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 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
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT07003425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07003425 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07003425 currently recruiting?
Yes, NCT07003425 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT07003425 trial being conducted?
This trial is being conducted at Fountain Valley, United States, Los Angeles, United States, Coral Gables, United States, Jacksonville, United States and 11 additional locations.
Who is sponsoring the NCT07003425 clinical trial?
NCT07003425 is sponsored by Apogee Therapeutics, Inc.. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 350 participants.
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