The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Dose 1
Unnamed facility
Helsinki, Finland
Unnamed facility
Tampere, Finland
Unnamed facility
Berlin, Germany
Unnamed facility
Dresden, Germany
Clinical Activity
To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.
Time frame: Week 2
Clinical Activity
To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.
Time frame: Week 4
Clinical Activity
To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.
Time frame: Week 6
Safety and tolerability a single IV dose of REGN846
To assess the safety and tolerability of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.
Time frame: Week 1 - Week 6
Pharmacokinetic (PK) profile of a single IV dose of REGN846
To assess the PK profile of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.
Time frame: Week 1 - Week 6
Immunogenicity of a single IV dose of REGN846
To assess the immunogenicity of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.
Time frame: Week 1 - Week 6
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Unnamed facility
Erfurt, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Mahlow, Germany
Unnamed facility
Mainz, Germany
Unnamed facility
Osnabrück, Germany
Unnamed facility
Tübingen, Germany
...and 4 more locations