A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• APG777 — DRUG
  APG777 subcutaneous injection
• APG777 — DRUG
  APG777 subcutaneous injection every 12 weeks
• APG777 — DRUG
  APG777 subcutaneous injection every 24 weeks

Study Details

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.

Key Dates

Start date

May 14, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

350 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: APG777 - Long Term Extension Treatment - 12 Weeks
  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).
• Experimental: APG777 - Long Term Extension Treatment - 24 Weeks
  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).
• Experimental: APG777 - Open Label Escape Arm
  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.

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to 3 years ]

Central Contacts

• Study Director
  7812082408
  [email protected]

Locations (22)

Find similar trials in Fountain Valley, CA

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