RECRUITING

A Study Evaluating TRIV-509 in Atopic Dermatitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-26
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07167758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has Atopic Dermatitis.
  2. * Has moderate to severe, active and symptomatic AD
  1. * Severe or uncontrolled medical conditions.
  2. * Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.

Contacts and Locations

Study Contact

Study Director Triveni Bio, Inc
CONTACT
17814722230
clinicaltrials@triveni.bio

Study Locations (Sites)

Triveni Bio Site #4
San Diego, California, 92123
United States
Triveni Bio Site #3
Miami, Florida, 33016
United States
Triveni Bio Site #6
Indianapolis, Indiana, 46250
United States
Triveni Bio Site #1
Camp Hill, Pennsylvania, 17011
United States
Triveni Bio Site #5
Dallas, Texas, 75230
United States
Triveni Bio Site #2
Dallas, Texas, 75254
United States

Collaborators and Investigators

Sponsor: Triveni Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-08-26
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Atopic Dermatitis