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Active, Not Recruiting

NCT Number: NCT07167758

A Study Evaluating TRIV-509 in Atopic Dermatitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Triveni Bio Site #38, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRIV-509

Drug

TRIV-509 (Subcutaneous injection)

Placebo

Drug

Drug: Placebo (Matching Placebo subcutaneous injection)

Primary outcomes

  1. Percentage of participants with improvement of AD at Week 16

    Time frame: Baseline to Week 16

Secondary outcomes

  1. Percentage of participants with improvement of AD at Week 16

    Time frame: Baseline through Week 16

  2. Percentage of participants with TEAEs.

    Time frame: For 16 Weeks

  3. Percentage of participants with SAEs.

    Time frame: For 16 Weeks

  4. Percentage of participants with anti-TRIV-509 antibodies

    Time frame: For 16 Weeks

  5. Serum concentration of TRIV-509

    Time frame: For 16 Weeks

Sponsors and collaborators

Lead sponsor

Triveni Bio

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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