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

2025-522113-35-00 · tracked via the Priya Life Science EU tracker

Sponsor

Triveni Bio Inc.

Sponsor type

Pharmaceutical company

Therapeutic area

Skin and Connective Tissue Diseases

Decision date

09/12/2025

Enrollment target

Sites

Poland, Bulgaria, Czechia, Hungary

Condition studied

Atopic dermatitis

Investigational medicinal product(s)

TRIV-509 Placebo (PRD12690501)TRIV-509

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

1. Percentage of participants with improvement of AD at Week 16

Endpoint detail

1. Percentage of participants with improvement of AD at Week 16 5. Percentage of participants with TEAEs 6. Percentage of participants with SAEs 7. Changes in vital signs, ECG parameters, and safety laboratory values 8. Single-dose and multiple-dose PK parameters 9. Percentage of participants with anti-TRIV-509 antibodies

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522113-35-00 on CTIS ↗ ← All trials in the EU