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A Study Evaluating TRIV-509 in Atopic Dermatitis
Sponsor: Triveni Bio
Summary
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.
Official title: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-08-26
Completion Date
2027-06
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
TRIV-509
TRIV-509 (Subcutaneous injection)
Placebo
Drug: Placebo (Matching Placebo subcutaneous injection)
Locations (44)
Triveni Bio Site #11
Fountain Valley, California, United States
Triveni Bio Site #4
San Diego, California, United States
Triveni Bio Site #44
New Haven, Connecticut, 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 #40
Sevlievo, Gabrovo, Bulgaria
Triveni Bio Site #35
Sofia, Sofia-Grad, Bulgaria
Triveni Bio Site #36
Sofia, Sofia-Grad, Bulgaria
Triveni Bio Site #32
Lovech, Bulgaria
Triveni Bio Site #38
Pleven, Bulgaria
Triveni Bio Site #39
Sofia, Bulgaria
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 #37
Prague, Czechia
Triveni Bio Site #23
Prague, Czechia
Triveni Bio Site #41
Budapest, Hungary
Triveni Bio Site #34
Budapest, Hungary
Triveni Bio Site #43
Debrecen, Hungary
Triveni Bio Site #33
Wroclaw, Lower Silesian Voivodeship, Poland
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 #42
Wroclaw, Poland
Triveni Bio Site #18
Kyiv, Ukraine