RecruitingPhase 2NCT07167758

A Study Evaluating TRIV-509 in Atopic Dermatitis

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


Sponsor

Triveni Bio

Enrollment

90 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Has Atopic Dermatitis.
  • Has moderate to severe, active and symptomatic AD

Exclusion Criteria2

  • Severe or uncontrolled medical conditions.
  • Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.

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Interventions

DRUGTRIV-509

TRIV-509 (Subcutaneous injection)

DRUGPlacebo

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

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NCT07167758


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