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
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Has Atopic Dermatitis.
• Has moderate to severe, active and symptomatic AD
Locations
United States
California
Triveni Bio Site #11
RECRUITING
Fountain Valley
Triveni Bio Site #4
RECRUITING
San Diego
Connecticut
Triveni Bio Site #44
RECRUITING
New Haven
Florida
Triveni Bio Site #3
RECRUITING
Miami
Triveni Bio Site #7
RECRUITING
Tampa
Triveni Bio Site #9
RECRUITING
Tampa
Indiana
Triveni Bio Site #6
RECRUITING
Indianapolis
Triveni Bio Site #10
RECRUITING
South Bend
Pennsylvania
Triveni Bio Site #1
RECRUITING
Camp Hill
Triveni Bio Site #20
RECRUITING
Pittsburgh
Texas
Triveni Bio Site #16
RECRUITING
Bellaire
Triveni Bio Site #2
RECRUITING
Dallas
Triveni Bio Site #5
RECRUITING
Dallas
Utah
Triveni Bio Site #14
RECRUITING
Springville
Washington
Triveni Bio Site #8
RECRUITING
Spokane
Other Locations
Bulgaria
Triveni Bio Site #32
RECRUITING
Lovech
Triveni Bio Site #38
RECRUITING
Pleven
Triveni Bio Site #40
RECRUITING
Sevlievo
Triveni Bio Site #35
RECRUITING
Sofia
Triveni Bio Site #36
RECRUITING
Sofia
Triveni Bio Site #39
RECRUITING
Sofia
Canada
Triveni Bio Site #13
RECRUITING
Ajax
Triveni Bio Site #17
RECRUITING
Newmarket
Triveni Bio Site #12
RECRUITING
Niagara Falls
Triveni Bio Site #15
RECRUITING
North York
Triveni Bio Site #19
RECRUITING
Ottawa
Hungary
Triveni Bio Site #34
RECRUITING
Budapest
Triveni Bio Site #41
RECRUITING
Budapest
Triveni Bio Site #43
RECRUITING
Debrecen
Poland
Triveni Bio Site #24
RECRUITING
Chorzów
Triveni Bio Site #25
RECRUITING
Katowice
Triveni Bio Site #27
RECRUITING
Katowice
Triveni Bio Site #26
RECRUITING
Poznan
Triveni Bio Site #30
RECRUITING
Poznan
Triveni Bio Site #29
RECRUITING
Sosnowiec
Triveni Bio Site #28
RECRUITING
Warsaw
Triveni Bio Site #33
RECRUITING
Wroclaw
Triveni Bio Site #42
RECRUITING
Wroclaw
Ukraine
Triveni Bio Site #18
RECRUITING
Kyiv
Contact Information
Primary
Study Director Triveni Bio, Inc
clinicaltrials@triveni.bio
17814722230
Time Frame
Start Date: 2025-08-26
Estimated Completion Date: 2027-06
Participants
Target number of participants: 90
Treatments
Experimental: First TRIV-509 then Placebo
Experimental: First Placebo then TRIV-509
Related Therapeutic Areas
Sponsors
Leads: Triveni Bio