This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.
This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Cornerstone Dermatology
Coorparoo, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, Australia
Pacific Clinical Research Network (PCRN) Auckland
Auckland, New Zealand
Eczema Area and Severity Index (EASI)
EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.
Time frame: 12 weeks
Investigator Global Assessment (IGA)
The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale \[0 (clear) to 4 (severe)\].
Time frame: 12 weeks
Body Surface Area (BSA)
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
Time frame: 12 weeks
Pruritus-NRS
The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating "no itch" and 10 indicating "worst itch imaginable".
Time frame: 12 weeks
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Optimal Clinical Trials North
Auckland, New Zealand
Optimal Clinical Trials
Auckland, New Zealand
Pacific Clinical Research Network (PCRN) Christchurch
Christchurch, New Zealand
Momentum Clinical Research Dunedin
Dunedin, New Zealand
Clinical Trials New Zealand Ltd
Hamilton, New Zealand
Momentum Clinical Research Lower Hutt
Hutt Central, New Zealand
Pacific Clinical Research Network (PCRN) Tasman
Nelson, New Zealand
...and 2 more locations