Atopic Dermatitis (AD)
Conditions
Keywords
Inflammatory response, pharmacokinetics, pharmacodynamics, immunogenicity
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy response of PRA-216 in patients with moderate to severe Atopic Dermatitis (AD). Eligible participants will be those with AD who are inadequately controlled by topical corticosteroids (TCS) or had adverse reaction or contraindication to the medication. This study will enroll approximately 39 participants at multiple study sites who will be randomized 2:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.
Interventions
DRUGActive PRA-216
biologic
DRUGPlacebo
matching placebo for PRA-216
Sponsors
Prana Therapies Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must be in good health with no significant medical history * Willing and able to attend all study visits, comply with study requirements. * Able and willing to provide written informed consent * Documented AD diagnosis prior for at least 6 months prior to enrollment. * History of inadequate response to topical medications for AD
Exclusion criteria
* Evidence of clinically significant skin condition or disease other than AD * Any physical or psychological condition that prohibits study completion * Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent * History of severe allergic reactions or hypersensitivity * Receipt of antibody therapy within 4 months or 5 half-lives * Other investigational agent(s) within 30 days or 5 half-lives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 28 weeks | Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe atopic dermatitis (AD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD | Up to 24 weeks | Mean percent change from baseline in Eczema Area and Severity Index (EASI). EASI is a score that will grade atopic dermatitis, with a higher number indicating more severe disease. A score of 0 indicates clear skin, and a score of 72 is severe disease. |
| Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75 | Up to 24 weeks | Percentage of patients achieving EASI-75. EASI-75 indicates a 75% improvement in severity and spread of skin lesions compared to baseline. |
| Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90 | Up to 24 weeks | Percentage of patients achieving EASI-90. EASI-90 indicates a 90% improvement in severity and spread of skin lesions compared to baseline. |
| Pharmacokinetics of PRA-216: Tmax in patients with AD | Up to 28 weeks | Time to maximum concentration of drug in plasma |
| Pharmacokinetics of PRA-216: AUC in patients with AD | Up to 28 weeks | Area under the curve |
| Pharmacokinetics of PRA-216: Cmax in patients with AD | Up to 28 weeks | Maximum concentration of PRA-216 in plasma |
| Immunogenicity of PRA-216: ADA in patients with AD | Up to 24 weeks | Incidence of anti-drug antibody following drug administration |
Countries
Australia, New Zealand
Outcome results
None listed