Back to resultsStudy of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCH 527123
SCH 527123
SCH 527123
SCH 527123
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.
Exclusion Criteria:
- Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Low dose SCH 527123
Medium dose SCH 527123
High dose SCH 527123
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Severe asthma exacerbations, pulmonary function test data, and a change in symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT01006161
First Posted
October 30, 2009
Last Updated
October 12, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01006161
Brief Title
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
Official Title
Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose SCH 527123
Arm Type
Experimental
Arm Title
Medium dose SCH 527123
Arm Type
Experimental
Arm Title
High dose SCH 527123
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SCH 527123
Intervention Description
Low dose
Intervention Type
Drug
Intervention Name(s)
SCH 527123
Intervention Description
Medium dose
Intervention Type
Drug
Intervention Name(s)
SCH 527123
Intervention Description
High dose
Intervention Type
Drug
Intervention Name(s)
SCH 527123
Intervention Description
Placebo to match SCH 527123
Primary Outcome Measure Information:
Title
Severe asthma exacerbations, pulmonary function test data, and a change in symptoms
Time Frame
Measured over the duration of the trial.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.
Exclusion Criteria:
Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
12. IPD Sharing Statement
Learn more about this trial
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
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