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

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 73 → 78 locations
  2. Study sites: 71 to 73
    • Eligibility criteria expanded, about 7 words
  3. Trial sites expanded: 68 → 71 locationsv24
  4. Study sites: 67 to 68v23
  5. Trial sites expanded: 63 → 67 locationsv22
  6. Study sites: 61 to 63v21
  7. Trial sites expanded: 56 → 61 locations
    • Eligibility criteria shortened, about 4 words
    v20
  8. Trial sites expanded: 50 → 56 locationsv19
  9. Study sites: 48 to 50v18
  10. Trial sites expanded: 45 → 48 locationsv17
  11. Trial sites expanded: 42 → 45 locationsv16
  12. Site details revised at 1 of 42 sitesv15
  13. Study sites: 40 to 42v14
  14. Study sites: 39 to 40v13
  15. Study sites: 37 to 39v12
  16. Study sites: 33 to 37v11
  17. Site details revised at 1 of 33 sitesv10
  18. Site details revised at 1 of 33 sitesv9
  19. Study sites: 32 to 33v8
  20. Site details revised at 10 of 32 sitesv7
  21. Study sites revised (32)v6
  22. Site details revised at 1 of 32 sitesv5
  23. Site details revised at 1 of 32 sitesv4
  24. Site details revised at 3 of 32 sitesv3
  25. Site details revised at 3 of 32 sitesv2
  26. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07003425
Lead Sponsor Apogee Therapeutics, Inc.
Conditions
(from sponsor)		 Atopic Dermatitis
Related terms Dermatitis, Atopic
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov