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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APG777 - Long Term Extension Treatment - 12 Weeks | Experimental | 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). |
|
| APG777 - Long Term Extension Treatment - 24 Weeks | Experimental | 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). |
|
| APG777 - Open Label Escape Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APG777 | Drug | APG777 subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline | Through Extended Treatment Period, an average of 2 years | |
| Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional protocol defined Inclusion/Exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 7812082408 | ClinicalTrials@apogeetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Recruiting | Fountain Valley | California | 92708 | United States | |
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| APG777 |
| Drug |
APG777 subcutaneous injection every 12 weeks |
|
| APG777 | Drug | APG777 subcutaneous injection every 24 weeks |
|
| Through Extended Treatment Period, an average of 2 years |
| Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline | Through Extended Treatment Period, an average of 2 years |
| Percentage of Participants who use Rescue Therapy | Through Extended Treatment Period, an average of 2 years |
| Percentage of Participants Who Continue to Exhibit EASI 75 | Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined | From Week 52 up to Through Extended Treatment Period, an average of 2 years |
| Percentage of Participants Who Continue to Exhibit vIGA-AD Response | Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. | From Week 52 up to Through Extended Treatment Period, an average of 2 years |
| Percentage of Participants Who Continue to Exhibit I-NRS Response | Of the participants who achieve a ≥ 4 point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. | From Week 52 up to Through Extended Treatment Period, an average of 2 years |
| Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs | Up to 3 years |
| Serum Concentrations of APG777 Over Time | Up to 3 years |
| Predose Serum Concentrations of APG777 | Up to 3 years |
| Investigational Site |
| Recruiting |
| Los Angeles |
| California |
| 90024 |
| United States |
| Investigational Site | Recruiting | Coral Gables | Florida | 33134 | United States |
| Investigational Site | Recruiting | Jacksonville | Florida | 32256 | United States |
| Investigational Site | Recruiting | Margate | Florida | 33063 | United States |
| Investigational Site | Recruiting | Douglasville | Georgia | 30135 | United States |
| Investigational Site | Recruiting | Skokie | Illinois | 60077 | United States |
| Investigational Site | Recruiting | Bowling Green | Kentucky | 42101 | United States |
| Investigational Site | Recruiting | Detroit | Michigan | 48202 | United States |
| Investigational Site | Recruiting | Troy | Michigan | 48084 | United States |
| Investigational Site | Recruiting | New York | New York | 10023 | United States |
| Investigational Site | Recruiting | Wilmington | North Carolina | 28403 | United States |
| Investigational Site | Recruiting | Boardman | Ohio | 44512 | United States |
| Investigational Site | Recruiting | Mason | Ohio | 45040 | United States |
| Investigational Site | Recruiting | Portland | Oregon | 97223 | United States |
| Investigational Site | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigational Site | Recruiting | Charleston | South Carolina | 29425 | United States |
| Investigational Site | Recruiting | Nashville | Tennessee | 37215 | United States |
| Investigational Site | Recruiting | Dallas | Texas | 75230 | United States |
| Investigational Site | Recruiting | Frisco | Texas | 75235 | United States |
| Investigational Site | Recruiting | San Antonio | Texas | 78213 | United States |
| Investigational Site | Recruiting | Mill Creek | Washington | 98012 | United States |
| Investigational Site | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Investigational Site | Recruiting | Calgary | Alberta | T3E 0B2 | Canada |
| Investigational Site | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
| Investigational Site | Recruiting | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Investigational Site | Recruiting | Fredericton | Brunswick | E3B 1G9 | Canada |
| Investigational Site | Recruiting | Ajax | Ontario | L1S 7K8 | Canada |
| Investigational Site | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
| Investigational Site | Recruiting | Mississauga | Ontario | L4Y 4C5 | Canada |
| Investigational Site | Recruiting | Ottawa | Ontario | K1K 4L2 | Canada |
| Investigational Site | Recruiting | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigational Site | Recruiting | Toronto | Ontario | M3B 0A7 | Canada |
| Investigational Site | Recruiting | Toronto | Ontario | M4E 2Y9 | Canada |
| Investigational Site | Recruiting | Toronto | Ontario | M4W 2N4 | Canada |
| Investigational Site | Recruiting | Montreal | Quebec | H2X 2V1 | Canada |
| Investigational Site | Recruiting | Québec | Quebec | G1V 4X7 | Canada |
| Investigational Site | Recruiting | Prague | 100 00 | Czechia |
| Investigational Site | Recruiting | Prague | 16000 | Czechia |
| Investigational Site | Recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Investigational Site | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Investigational Site | Recruiting | Augsburg | Bavaria | 86179 | Germany |
| Investigational Site | Recruiting | München | Bavaria | 80337 | Germany |
| Investigational Site | Recruiting | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Investigational Site | Recruiting | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Investigational Site | Recruiting | Münster | North Rhine Westfalia | 48149 | Germany |
| Investigational Site | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
| Investigational Site | Recruiting | Hamburg | 20354 | Germany |
| Investigational Site | Recruiting | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Investigational Site | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-450 | Poland |
| Investigational Site | Recruiting | Wroclaw | Lower Silesian Voivodeship | 51-503 | Poland |
| Investigational Site | Recruiting | Lublin | Lublin Voivodeship | 20-573 | Poland |
| Investigational Site | Recruiting | Warsaw | Masovian Voivodeship | 01-595 | Poland |
| Investigational Site | Recruiting | Warsaw | Masovian Voivodeship | 02-482 | Poland |
| Investigational Site | Recruiting | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Investigational Site | Recruiting | Katowice | Silesian Voivodeship | 40-600 | Poland |
| Investigational Site | Recruiting | Sosnowiec | Silesian Voivodeship | 41-218 | Poland |
| Investigational Site | Recruiting | Szczecin | West Pomeranian Voivodeship | 71-500 | Poland |
| Investigational Site | Recruiting | Krakow | Woj. Małopolskie | 30-727 | Poland |
| Investigational Site | Recruiting | Lodz | 90-237 | Poland |
| Investigational Site | Recruiting | Santiago de Compostela | A Coruña | 15706 | Spain |
| Investigational Site | Recruiting | Las Palmas de Gran Canaria | Canary Islands | 35010 | Spain |
| Investigational Site | Recruiting | Madrid | 28006 | Spain |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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