NCT07782333

Brief Summary

The goal of this interventional study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-573. Participants will receive 5 doses of the study intervention that they are randomized to (TRIV-573 or placebo). The study duration for individual participants is up to 40 weeks, including a Screening period of up to 30 days.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
17mo left

Started Aug 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026Feb 2028

Study Start

First participant enrolled

August 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 18, 2026

Last Update Submit

August 20, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with improvement of AD

    Baseline through Week 16

Secondary Outcomes (4)

  • Percentage of participants with improvement of AD

    Baseline through Week 16

  • Percentage of participants with TEAEs

    Baseline through Week 36

  • Serum concentration of TRIV-573

    Baseline through Week 36

  • Percentage of participants with anti-TRIV-573 antibodies

    Baseline through Week 36

Study Arms (2)

TRIV-573

EXPERIMENTAL
Drug: TRIV-573

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TRIV-573DRUG

TRIV-573 (Subcutaneous injection)

TRIV-573
PlaceboDRUG

Placebo (Matching Placebo subcutaneous injection)

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe or uncontrolled medical conditions.
  • Use of prohibited medications within stated washout periods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Triveni Bio, Inc

CONTACT

+1 (781) 472-2230clinicaltrials@triveni.bio

Study Design

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

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share