Actively Recruiting
A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
Led by Apogee Therapeutics, Inc. · Updated on 2026-06-08
350
Participants Needed
56
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term safety and effects of APG777 in adults with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a prior APG777 study. This Phase 2, multicenter, double-blind extension study aims to understand how well APG777 works and how safe it is when used over a longer period in patients who might benefit from continued treatment. The study includes three periods: a screening visit aligned with the end of the parent study's maintenance phase, an extended treatment period, and a post-treatment follow-up phase. Participants who met certain response criteria and did not use rescue medication in the parent study will continue with the same dosing schedule of APG777 injections. Those who did not meet these criteria or used rescue medication will be assigned to an open-label escape arm and receive APG777 according to a set dosing regimen. Treatment involves subcutaneous injections of APG777 every 12 or 24 weeks. Participants will be closely monitored throughout the study, which may last up to three years. Researchers will evaluate treatment-emergent adverse events, measure improvements in eczema severity using the Eczema Area and Severity Index (EASI), assess skin clearance via Investigator Global Assessment scores, and track itch severity using a numeric rating scale. Use of rescue therapy, treatment discontinuations related to adverse effects, and serum drug levels will also be recorded. The study aims to track long-term safety and ongoing benefits of APG777 in this patient group.
CONDITIONS
Brief Title
A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Participants who have developed an adverse event during the Parent Study that may indicate continued treatment with APG777 is unsafe
- Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
- Use of any prohibited medications from the Parent Study through the Screening Visit of the LTE study
- Presence of dermatologic conditions or other illnesses that could confuse the diagnosis of atopic dermatitis or interfere with assessments
- Additional protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 3 years
Participants receive APG777 subcutaneous injections to maintain or improve their atopic dermatitis condition based on prior treatment response.
Injections every 12 or 24 weeks depending on the assigned regimen
Trial Site Locations
Total: 56 locations
1
Investigational Site
Fountain Valley, California, United States, 92708
Actively Recruiting
2
Investigational Site
Los Angeles, California, United States, 90024
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3
Investigational Site
Coral Gables, Florida, United States, 33134
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4
Investigational Site
Jacksonville, Florida, United States, 32256
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5
Investigational Site
Margate, Florida, United States, 33063
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6
Investigational Site
Douglasville, Georgia, United States, 30135
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7
Investigational Site
Skokie, Illinois, United States, 60077
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8
Investigational Site
Bowling Green, Kentucky, United States, 42101
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9
Investigational Site
Detroit, Michigan, United States, 48202
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10
Investigational Site
Troy, Michigan, United States, 48084
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11
Investigational Site
New York, New York, United States, 10023
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12
Investigational Site
Wilmington, North Carolina, United States, 28403
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13
Investigational Site
Boardman, Ohio, United States, 44512
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14
Investigational Site
Mason, Ohio, United States, 45040
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15
Investigational Site
Portland, Oregon, United States, 97223
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16
Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
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17
Investigational Site
Charleston, South Carolina, United States, 29425
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18
Investigational Site
Nashville, Tennessee, United States, 37215
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19
Investigational Site
Dallas, Texas, United States, 75230
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20
Investigational Site
Frisco, Texas, United States, 75235
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21
Investigational Site
San Antonio, Texas, United States, 78213
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22
Investigational Site
Mill Creek, Washington, United States, 98012
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23
Investigational Site
Calgary, Alberta, Canada, T2J 7E1
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24
Investigational Site
Calgary, Alberta, Canada, T3E 0B2
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25
Investigational Site
Edmonton, Alberta, Canada, T5J 3S9
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26
Investigational Site
Fredericton, Brunswick, Canada, E3B 1G9
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27
Investigational Site
Ajax, Ontario, Canada, L1S 7K8
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28
Investigational Site
Markham, Ontario, Canada, L3P 1X3
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29
Investigational Site
Mississauga, Ontario, Canada, L4Y 4C5
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30
Investigational Site
Peterborough, Ontario, Canada, K9J 5K2
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31
Investigational Site
Toronto, Ontario, Canada, M3B 0A7
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32
Investigational Site
Toronto, Ontario, Canada, M4E 2Y9
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33
Investigational Site
Toronto, Ontario, Canada, M4W 2N4
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34
Investigational Site
Montreal, Quebec, Canada, H2X 2V1
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35
Investigational Site
Québec, Quebec, Canada, G1V 4X7
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36
Investigational Site
Tübingen, Baden-Wurttemberg, Germany, 72076
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37
Investigational Site
München, Bavaria, Germany, 80337
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38
Investigational Site
Blankenfelde-Mahlow, Brandenburg, Germany, 15831
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39
Investigational Site
Bad Bentheim, Lower Saxony, Germany, 48455
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40
Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
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41
Investigational Site
Hamburg, Germany, 20354
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42
Investigational Site
Debrecen, Hajdú-Bihar, Hungary, 4032
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43
Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland, 50-450
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44
Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
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45
Investigational Site
Lublin, Lublin Voivodeship, Poland, 20-573
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46
Investigational Site
Warsaw, Masovian Voivodeship, Poland, 01-595
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47
Investigational Site
Warsaw, Masovian Voivodeship, Poland, 02-482
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48
Investigational Site
Gdansk, Pomeranian Voivodeship, Poland, 80-546
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49
Investigational Site
Katowice, Silesian Voivodeship, Poland, 40-600
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50
Investigational Site
Sosnowiec, Silesian Voivodeship, Poland, 41-218
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51
Investigational Site
Szczecin, West Pomeranian Voivodeship, Poland, 71-500
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52
Investigational Site
Krakow, Woj. Małopolskie, Poland, 30-727
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53
Investigational Site
Lodz, Poland, 90-237
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54
Investigational Site
Santiago de Compostela, A Coruña, Spain, 15706
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55
Investigational Site
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
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56
Investigational Site
Madrid, Spain, 28006
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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