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

October 12, 2015 updated by: Merck Sharp & Dohme LLC

Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: SCH 527123
Low dose
Drug: SCH 527123
Medium dose
Drug: SCH 527123
High dose
Drug: SCH 527123
Placebo to match SCH 527123
Experimental: Low dose SCH 527123
Drug: SCH 527123
Low dose
Drug: SCH 527123
Medium dose
Drug: SCH 527123
High dose
Drug: SCH 527123
Placebo to match SCH 527123
Experimental: Medium dose SCH 527123
Drug: SCH 527123
Low dose
Drug: SCH 527123
Medium dose
Drug: SCH 527123
High dose
Drug: SCH 527123
Placebo to match SCH 527123
Experimental: High dose SCH 527123
Drug: SCH 527123
Low dose
Drug: SCH 527123
Medium dose
Drug: SCH 527123
High dose
Drug: SCH 527123
Placebo to match SCH 527123

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05109
  • EUDRACT No.: 2008-004119-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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