NCT07167758

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Triveni Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	TRIV-509	TRIV-509 (Subcutaneous injection)
DRUG	Placebo	Drug: Placebo (Matching Placebo subcutaneous injection)

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-10-01
• Completion: 2027-06-01
• First posted: 2025-09-11
• Last updated: 2026-04-02

Locations

44 sites across 7 countries: United States, Bulgaria, Canada, Czechia, Hungary, Poland, Ukraine

Regulatory

• FDA-regulated drug study