A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003 AM2)
Status: | Completed |
---|---|
Conditions: | Psoriasis, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | December 2012 |
End Date: | June 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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,
pharmacodynamics, and immunogenicity of MK-8226 in participants with moderate to severe
atopic dermatitis. Part 1 will be done to find the maximum tolerated dose (MTD) of MK-8226
and to assess safety and pharmacokinetics. Part 2 will evaluate safety, pharmacokinetics,
and preliminary efficacy. Part 3, if done, will further define safety and pharmacokinetics,
and will explore MK-8226 pharmacokinetic/pharmacodynamics to model the optimal dose range
for future studies if Part 1 does not supply sufficient information to do this.
pharmacodynamics, and immunogenicity of MK-8226 in participants with moderate to severe
atopic dermatitis. Part 1 will be done to find the maximum tolerated dose (MTD) of MK-8226
and to assess safety and pharmacokinetics. Part 2 will evaluate safety, pharmacokinetics,
and preliminary efficacy. Part 3, if done, will further define safety and pharmacokinetics,
and will explore MK-8226 pharmacokinetic/pharmacodynamics to model the optimal dose range
for future studies if Part 1 does not supply sufficient information to do this.
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.
An interim futility analysis will be performed when approximately 40% of the participants
that have been treated with study drug have completed the active treatment portion of the
study (Week 12) while additional patients will continue to be enrolled into Part 2 of the
study. If the interim results support study continuation, additional participants may be
enrolled in Part 3 of the study.
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.
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.
An interim futility analysis will be performed when approximately 40% of the participants
that have been treated with study drug have completed the active treatment portion of the
study (Week 12) while additional patients will continue to be enrolled into Part 2 of the
study. If the interim results support study continuation, additional participants may be
enrolled in Part 3 of the study.
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.
Inclusion Criteria:
- Body weight >=40 kg
- Clinical diagnosis of atopic dermatitis for at least 6 months prior
- Candidate for systemic or phototherapy (i.e., failed topical treatment)
- Moderate-to-severe disease as defined by Body Surface Area (BSA) ≥10%, EASI ≥12, and
IGA ≥3
- No clinically significant abnormality on electrocardiogram
- No history of active or latent TB and no signs or symptoms suggestive of TB
- No history of active or latent TB and no signs or symptoms suggestive of TB
- History of inadequate response to a stable (≥ 1 month) regimen of topical
corticosteroids or calcineurin inhibitors within 3 months before the screening visit
Exclusion Criteria:
- Concurrent significant skin disease
- Any significant organ dysfunction within 6 months prior
- History of clinically significant heart disease
- History of neoplastic disease
- Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- Infection requiring oral antibiotics within 2 weeks prior
- Receipt of a live virus vaccine within 4 weeks prior
- Inability to refrain from topical or systemic therapy during course of the study
- Had major surgery or donated or lost >=1 unit of blood within 4 weeks prior
- Participation in another study within 4 weeks prior
- Current or regular user of illicit drugs or a history of drug or alcohol abuse within
1 year prior
- Pregnant, breast-feeding, or anticipated to conceive during the course of the study
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