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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522113-35-00

Acronym

509-101

Enrollment

Registered

2025-12-09

Start date

2026-01-07

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Brief summary

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

Detailed description

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

Interventions

DRUGTRIV-509

DRUGTRIV-509 Placebo (PRD12690501)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Percentage of participants with improvement of AD at Week 16	—

Secondary

Measure	Time frame
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	—

Countries

Bulgaria, Czechia, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026