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The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First TRIV-509 then Placebo | Experimental |
| |
| First Placebo then TRIV-509 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIV-509 | Drug | TRIV-509 (Subcutaneous injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with improvement of AD at Week 16 | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with improvement of AD at Week 16 | Baseline through Week 16 | |
| Percentage of participants with TEAEs. | For 16 Weeks | |
| Percentage of participants with SAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Triveni Bio Site #11 | Fountain Valley | California | 17271 | United States | ||
| Triveni Bio Site #4 |
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| Placebo | Drug | Drug: Placebo (Matching Placebo subcutaneous injection) |
|
| For 16 Weeks |
| Percentage of participants with anti-TRIV-509 antibodies | For 16 Weeks |
| Serum concentration of TRIV-509 | For 16 Weeks |
| San Diego |
| California |
| 92123 |
| United States |
| Triveni Bio Site #3 | Miami | Florida | 33016 | United States |
| Triveni Bio Site #6 | Indianapolis | Indiana | 46250 | United States |
| Triveni Bio Site #10 | South Bend | Indiana | 46617 | United States |
| Triveni Bio Site #1 | Camp Hill | Pennsylvania | 17011 | United States |
| Triveni Bio Site #16 | Bellaire | Texas | 77401 | United States |
| Triveni Bio Site #5 | Dallas | Texas | 75230 | United States |
| Triveni Bio Site #8 | Spokane | Washington | 99202 | United States |
| Triveni Bio Site #38 | Pleven | 5800 | Bulgaria |
| Triveni Bio Site #39 | Sofia | 1172 | Bulgaria |
| Triveni Bio Site #13 | Ajax | Ontario | L1S 7K8 | Canada |
| Triveni Bio Site #17 | Newmarket | Ontario | L3Y 5G8 | Canada |
| Triveni Bio Site #12 | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Triveni Bio Site #15 | North York | Ontario | M2N 3A6 | Canada |
| Triveni Bio Site #22 | Ostrava | 70200 | Czechia |
| Triveni Bio Site #31 | Pardubice | 530 02 | Czechia |
| Triveni Bio Site #21 | Prague | 11000 | Czechia |
| Triveni Bio Site #37 | Prague | 13000 | Czechia |
| Triveni Bio Site #23 | Prague | 15000 | Czechia |
| Triveni Bio Site #41 | Budapest | 1033 | Hungary |
| Triveni Bio Site #34 | Budapest | 1066 | Hungary |
| Triveni Bio Site #43 | Debrecen | 4032 | Hungary |
| Triveni Bio Site #33 | Wroclaw | Lower Silesian Voivodeship | 51-604 | Poland |
| Triveni Bio Site #28 | Warsaw | Masovian Voivodeship | 00-872 | Poland |
| Triveni Bio Site #24 | Chorzów | Silesian Voivodeship | 41-500 | Poland |
| Triveni Bio Site #25 | Katowice | Silesian Voivodeship | 4-600 | Poland |
| Triveni Bio Site #27 | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Triveni Bio Site #30 | Poznan | Wielkopolska | 60-309 | Poland |
| Triveni Bio Site #26 | Poznan | Wielkopolska | 61-731 | Poland |
| Triveni Bio Site #29 | Sosnowiec | 41-200 | Poland |
| Triveni Bio Site #18 | Kyiv | 01135 | Ukraine |
| 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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