Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-08-26
2027-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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First TRIV-509 then Placebo
TRIV-509
TRIV-509 (Subcutaneous injection)
Placebo
Drug: Placebo (Matching Placebo subcutaneous injection)
First Placebo then TRIV-509
TRIV-509
TRIV-509 (Subcutaneous injection)
Placebo
Drug: Placebo (Matching Placebo subcutaneous injection)
Interventions
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TRIV-509
TRIV-509 (Subcutaneous injection)
Placebo
Drug: Placebo (Matching Placebo subcutaneous injection)
Eligibility Criteria
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Inclusion Criteria
* Has moderate to severe, active and symptomatic AD
Exclusion Criteria
* Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.
18 Years
75 Years
ALL
No
Sponsors
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Triveni Bio
INDUSTRY
Responsible Party
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Locations
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Triveni Bio Site #11
Fountain Valley, California, United States
Triveni Bio Site #4
San Diego, California, United States
Triveni Bio Site #3
Miami, Florida, United States
Triveni Bio Site #7
Tampa, Florida, United States
Triveni Bio Site #9
Tampa, Florida, United States
Triveni Bio Site #6
Indianapolis, Indiana, United States
Triveni Bio Site #10
South Bend, Indiana, United States
Triveni Bio Site #1
Camp Hill, Pennsylvania, United States
Triveni Bio Site #20
Pittsburgh, Pennsylvania, United States
Triveni Bio Site #16
Bellaire, Texas, United States
Triveni Bio Site #5
Dallas, Texas, United States
Triveni Bio Site #2
Dallas, Texas, United States
Triveni Bio Site #14
Springville, Utah, United States
Triveni Bio Site #8
Spokane, Washington, United States
Triveni Bio Site #13
Ajax, Ontario, Canada
Triveni Bio Site #17
Newmarket, Ontario, Canada
Triveni Bio Site #12
Niagara Falls, Ontario, Canada
Triveni Bio Site #15
North York, Ontario, Canada
Triveni Bio Site #19
Ottawa, Ontario, Canada
Triveni Bio Site #22
Ostrava, , Czechia
Triveni Bio Site #31
Pardubice, , Czechia
Triveni Bio Site #21
Prague, , Czechia
Triveni Bio Site #23
Prague, , Czechia
Triveni Bio Site #28
Warsaw, Masovian Voivodeship, Poland
Triveni Bio Site #24
Chorzów, Silesian Voivodeship, Poland
Triveni Bio Site #25
Katowice, Silesian Voivodeship, Poland
Triveni Bio Site #27
Katowice, Silesian Voivodeship, Poland
Triveni Bio Site #30
Poznan, Wielkopolska, Poland
Triveni Bio Site #26
Poznan, Wielkopolska, Poland
Triveni Bio Site #29
Sosnowiec, , Poland
Triveni Bio Site #18
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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509-101
Identifier Type: -
Identifier Source: org_study_id
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