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Topical PRN473 (Atuzabrutinib) in mild to moderate atopic dermatitis
NCT04992546Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2021
- Primary completion
- Dec 2022
- Countries
- 2
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- edralbrutinib
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, randomised, double-blind trial of edralbrutinib in atopic dermatitis (AD) (2 arms), sponsored by Sanofi. Primary endpoints: Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events, Number of Participants With Potentially Clinically Significant Abnormalities: Vital Signs and 8 more. Started Aug 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lesion A (Active -> Active)
Lesion treated with SAR444727 during blinded period, then SAR444727 during OL period.
Lesion B (Placebo -> Active)
Lesion treated with Placebo during blinded period, then SAR444727 during OL period.
03
Who it enrols
Adults with mild to moderate atopic dermatitis for at least 6 months, stable for 4 weeks, with 1-14% BSA involvement and at least two comparable target lesions.
04
Endpoints
Primary
Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events
Number of Participants With Potentially Clinically Significant Abnormalities: Vital Signs
Number of Participants With Potentially Clinically Significant Abnormalities in 12-Lead Electrocardiogram
Number of Participants With Potentially Clinically Significant Abnormalities: Hematology
Number of Participants With Potentially Clinically Significant Abnormalities: Electrolyte Parameters
Secondary
Maximum Plasma Concentration (Cmax) of SAR444727
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