Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGTRIV-509
TRIV-509 (Subcutaneous injection)
DRUGPlacebo
Drug: Placebo (Matching Placebo subcutaneous injection)
Sponsors
Triveni Bio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with improvement of AD at Week 16 | Baseline to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with improvement of AD at Week 16 | Baseline through Week 16 |
| Percentage of participants with TEAEs. | For 16 Weeks |
| Percentage of participants with SAEs. | For 16 Weeks |
| Percentage of participants with anti-TRIV-509 antibodies | For 16 Weeks |
| Serum concentration of TRIV-509 | For 16 Weeks |
Countries
Bulgaria, Canada, Czechia, Hungary, Poland, Ukraine, United States
Outcome results
None listed