Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 30, 2009
Last updated: October 24, 2014
Last verified: October 2014

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
Drug: SCH 527123
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01006161     History of Changes
Other Study ID Numbers: P05109, EUDRACT No.: 2008-004119-36
Study First Received: October 30, 2009
Last Updated: October 24, 2014
Health Authority: Canada: Health Canada, Therapeutic Products Directorate processed this record on March 03, 2015