PRA-216 Atopic Dermatitis Safety and Efficacy Study

Phase 2Not Yet RecruitingNCT07810777

Prana Therapies Inc39 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis (AD)

Interventions

Active PRA-216DRUG

biologic

PlaceboDRUG

matching placebo for PRA-216

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (8)

Emeritus Sydney

Botany, New South Wales, Australia

Cornerstone Centre for Clinical Research

Coorparoo, Queensland, Australia

Emeritus Melbourne

Camberwell, Victoria, Australia

Momentum Sunshine

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

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)

Time frame: Up to 28 weeks

Secondary Outcomes

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD

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.

Time frame: Up to 24 weeks

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75

Percentage of patients achieving EASI-75. EASI-75 indicates a 75% improvement in severity and spread of skin lesions compared to baseline.

Time frame: Up to 24 weeks

Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90

Percentage of patients achieving EASI-90. EASI-90 indicates a 90% improvement in severity and spread of skin lesions compared to baseline.

Time frame: Up to 24 weeks

Pharmacokinetics of PRA-216: Tmax in patients with AD

Time to maximum concentration of drug in plasma

Time frame: Up to 28 weeks

Pharmacokinetics of PRA-216: AUC in patients with AD

Area under the curve

Time frame: Up to 28 weeks

Data from ClinicalTrials.gov

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