Conditions: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks. arm 2: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 3: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 4: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 5: Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. arm 6: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 7: Placebo administered IV every 2 weeks for a period of 12 weeks.

Interventions: intervention 1: MK-8226 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks. intervention 2: Placebo administered IV every 2 weeks for a period of 12 weeks.

Protocol document: