A Study Evaluating TRIV-509 in Atopic Dermatitis

NCT07167758 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 509-101
• Study Type: interventional
• Target: 95
• Locations: 7 countries
• Sites: 32

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with improvement of AD at Week 16

  Baseline to Week 16

Secondary Outcomes (5)

• Percentage of participants with improvement of AD at Week 16

  Baseline through Week 16

• Percentage of participants with TEAEs.

  For 16 Weeks

• Percentage of participants with SAEs.

  For 16 Weeks

• Percentage of participants with anti-TRIV-509 antibodies

  For 16 Weeks

• Serum concentration of TRIV-509

  For 16 Weeks

Study Arms (2)

First TRIV-509 then Placebo

EXPERIMENTAL

Drug: TRIV-509; Drug: Placebo

First Placebo then TRIV-509

EXPERIMENTAL

Drug: TRIV-509; Drug: Placebo

Interventions

TRIV-509 DRUG

TRIV-509 (Subcutaneous injection)

First Placebo then TRIV-509; First TRIV-509 then Placebo

Placebo DRUG

Drug: Placebo (Matching Placebo subcutaneous injection)

First Placebo then TRIV-509; First TRIV-509 then Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Triveni Bio: lead

Study Sites (32)

Triveni Bio Site #11

Fountain Valley, California, 17271, United States

Location

Triveni Bio Site #4

San Diego, California, 92123, United States

Location

Triveni Bio Site #3

Miami, Florida, 33016, United States

Location

Triveni Bio Site #6

Indianapolis, Indiana, 46250, United States

Location

Triveni Bio Site #10

South Bend, Indiana, 46617, United States

Location

Triveni Bio Site #1

Camp Hill, Pennsylvania, 17011, United States

Location

Triveni Bio Site #16

Bellaire, Texas, 77401, United States

Location

Triveni Bio Site #5

Dallas, Texas, 75230, United States

Location

Triveni Bio Site #8

Spokane, Washington, 99202, United States

Location

Triveni Bio Site #38

Pleven, 5800, Bulgaria

Location

Triveni Bio Site #39

Sofia, 1172, Bulgaria

Location

Triveni Bio Site #13

Ajax, Ontario, L1S 7K8, Canada

Location

Triveni Bio Site #17

Newmarket, Ontario, L3Y 5G8, Canada

Location

Triveni Bio Site #12

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Triveni Bio Site #15

North York, Ontario, M2N 3A6, Canada

Location

Triveni Bio Site #22

Ostrava, 70200, Czechia

Location

Triveni Bio Site #31

Pardubice, 530 02, Czechia

Location

Triveni Bio Site #21

Prague, 11000, Czechia

Location

Triveni Bio Site #37

Prague, 13000, Czechia

Location

Triveni Bio Site #23

Prague, 15000, Czechia

Location

Triveni Bio Site #41

Budapest, 1033, Hungary

Location

Triveni Bio Site #34

Budapest, 1066, Hungary

Location

Triveni Bio Site #43

Debrecen, 4032, Hungary

Location

Triveni Bio Site #33

Wroclaw, Lower Silesian Voivodeship, 51-604, Poland

Location

Triveni Bio Site #28

Warsaw, Masovian Voivodeship, 00-872, Poland

Location

Triveni Bio Site #24

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Triveni Bio Site #25

Katowice, Silesian Voivodeship, 4-600, Poland

Location

Triveni Bio Site #27

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Triveni Bio Site #30

Poznan, Wielkopolska, 60-309, Poland

Location

Triveni Bio Site #26

Poznan, Wielkopolska, 61-731, Poland

Location

Triveni Bio Site #29

Sosnowiec, 41-200, Poland

Location

Triveni Bio Site #18

Kyiv, 01135, Ukraine

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 11, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2); CZ (5); PL (8); US (9); CA (4); HU (3); UA (1)