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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Percentage of participants with improvement of AD at Week 16
Time frame: Baseline to Week 16
Percentage of participants with improvement of AD at Week 16
Time frame: Baseline through Week 16
Percentage of participants with TEAEs.
Time frame: For 16 Weeks
Percentage of participants with SAEs.
Time frame: For 16 Weeks
Percentage of participants with anti-TRIV-509 antibodies
Time frame: For 16 Weeks
Serum concentration of TRIV-509
Time frame: For 16 Weeks
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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 #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 #16
Bellaire, Texas, United States
Triveni Bio Site #5
Dallas, Texas, United States
Triveni Bio Site #8
Spokane, Washington, United States
Triveni Bio Site #38
Pleven, Bulgaria
...and 22 more locations