PRA-216 Atopic Dermatitis Safety and Efficacy Study

ClinicalTrials.gov ID

NCT07810777

Lead Sponsor

Prana Therapies IncINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

39Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Oct 1, 2027Estimated

Official Title

A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of PRA-216 in Participants With Moderate to Severe Atopic Dermatitis

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.

• Atopic Dermatitis (AD)

• Active PRA-216
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Prana Therapies IncINDUSTRY

drkim@cornerstonederm.com.au+61 7 2102 5054

rafikmalik@emeritusresearch.com03 9509 6166

King.Cheung@momentumclinicalresearch.com.au03 9125 0799

Claudette@optimalclinicaltrials.com+64 9 303 4987

cheng.huang@TeWhatuOra.govt.nz+64 9 276 0000

benimage@pcrn.co.nz64 3 337 1976

amystanway@yahoo.co.nz+64 7 843 0105

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