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Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

This study has been withdrawn prior to enrollment.
ClinicalTrials.gov Identifier:
First Posted: November 2, 2009
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.

Condition Intervention Phase
Asthma Drug: SCH 527123 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Severe asthma exacerbations, pulmonary function test data, and a change in symptoms [ Time Frame: Measured over the duration of the trial. ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose SCH 527123 Drug: SCH 527123
Low dose
Experimental: Medium dose SCH 527123 Drug: SCH 527123
Medium dose
Experimental: High dose SCH 527123 Drug: SCH 527123
High dose
Placebo Comparator: Placebo Drug: SCH 527123
Placebo to match SCH 527123


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01006161     History of Changes
Other Study ID Numbers: P05109
EUDRACT No.: 2008-004119-36
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases