Atopic Dermatitis Clinical Trial
Official title:
A Phase Ib Randomized, Double-Blinded, Placebo-Controlled Multiple Rising Dose Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MK-8226 in Patients With Moderate to Severe Atopic Dermatitis
This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies. The study was terminated early due to business reasons on 08 May 2014; final results from an analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety, immunogenicity) are summarized.
Part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and
pharmacokinetics of MK-8226 for a period of 12 weeks followed by a 20-week off-treatment
follow-up period.
Part 2 of the study is an assessment of the safety, tolerability, and efficacy of MK-8226 for
12 weeks followed by a 20-week off-treatment follow-up period.
In Part 3 of the study, participants will be treated with MK-8226 for a period of 12 weeks
followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and
pharmacokinetic correlations to assist with modeling the dose range planned for further
studies.
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