A Study Evaluating TRIV-509 in Atopic Dermatitis

NCT ID: NCT07167758

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-26

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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First TRIV-509 then Placebo

Group Type EXPERIMENTAL

TRIV-509

Intervention Type DRUG

TRIV-509 (Subcutaneous injection)

Placebo

Intervention Type DRUG

Drug: Placebo (Matching Placebo subcutaneous injection)

First Placebo then TRIV-509

Group Type EXPERIMENTAL

TRIV-509

Intervention Type DRUG

TRIV-509 (Subcutaneous injection)

Placebo

Intervention Type DRUG

Drug: Placebo (Matching Placebo subcutaneous injection)

Interventions

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TRIV-509

TRIV-509 (Subcutaneous injection)

Intervention Type DRUG

Placebo

Drug: Placebo (Matching Placebo subcutaneous injection)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triveni Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Triveni Bio Site #11

Fountain Valley, California, United States

Site Status RECRUITING

Triveni Bio Site #4

San Diego, California, United States

Site Status RECRUITING

Triveni Bio Site #3

Miami, Florida, United States

Site Status RECRUITING

Triveni Bio Site #7

Tampa, Florida, United States

Site Status RECRUITING

Triveni Bio Site #9

Tampa, Florida, United States

Site Status RECRUITING

Triveni Bio Site #6

Indianapolis, Indiana, United States

Site Status RECRUITING

Triveni Bio Site #10

South Bend, Indiana, United States

Site Status RECRUITING

Triveni Bio Site #1

Camp Hill, Pennsylvania, United States

Site Status RECRUITING

Triveni Bio Site #20

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Triveni Bio Site #16

Bellaire, Texas, United States

Site Status RECRUITING

Triveni Bio Site #5

Dallas, Texas, United States

Site Status RECRUITING

Triveni Bio Site #2

Dallas, Texas, United States

Site Status RECRUITING

Triveni Bio Site #14

Springville, Utah, United States

Site Status RECRUITING

Triveni Bio Site #8

Spokane, Washington, United States

Site Status RECRUITING

Triveni Bio Site #13

Ajax, Ontario, Canada

Site Status RECRUITING

Triveni Bio Site #17

Newmarket, Ontario, Canada

Site Status RECRUITING

Triveni Bio Site #12

Niagara Falls, Ontario, Canada

Site Status RECRUITING

Triveni Bio Site #15

North York, Ontario, Canada

Site Status RECRUITING

Triveni Bio Site #19

Ottawa, Ontario, Canada

Site Status RECRUITING

Triveni Bio Site #22

Ostrava, , Czechia

Site Status RECRUITING

Triveni Bio Site #31

Pardubice, , Czechia

Site Status RECRUITING

Triveni Bio Site #21

Prague, , Czechia

Site Status RECRUITING

Triveni Bio Site #23

Prague, , Czechia

Site Status RECRUITING

Triveni Bio Site #28

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Triveni Bio Site #24

Chorzów, Silesian Voivodeship, Poland

Site Status RECRUITING

Triveni Bio Site #25

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Triveni Bio Site #27

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Triveni Bio Site #30

Poznan, Wielkopolska, Poland

Site Status RECRUITING

Triveni Bio Site #26

Poznan, Wielkopolska, Poland

Site Status RECRUITING

Triveni Bio Site #29

Sosnowiec, , Poland

Site Status RECRUITING

Triveni Bio Site #18

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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United States Canada Czechia Poland Ukraine

Central Contacts

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Study Director Triveni Bio, Inc

Role: CONTACT

17814722230

Facility Contacts

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Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Study Director

Role: primary

781-472-2230

Other Identifiers

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509-101

Identifier Type: -

Identifier Source: org_study_id

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