A Study Evaluating TRIV-509 in Atopic Dermatitis

Triveni Bio

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: TRIV-509; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07167758

509-101

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

First TRIV-509 then Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: TRIV-509

First Placebo then TRIV-509

Experimental group

Treatment:

Drug: Placebo

Drug: TRIV-509