Atopic Dermatitis
Conditions
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.
Interventions
TRIV-573 (Subcutaneous injection)
Placebo (Matching Placebo subcutaneous injection)
Sponsors
Study design
Eligibility
Inclusion criteria
* Has Atopic Dermatitis. * Has moderate to severe, active and symptomatic atopic dermatitis.
Exclusion criteria
* Severe or uncontrolled medical conditions. * Use of prohibited medications within stated washout periods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with improvement of AD | Baseline through Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |