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

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006161
Enrollment
0
Registered
2009-11-02
Start date
2010-01-31
Completion date
2012-08-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

Low dose

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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).

Design outcomes

Primary

MeasureTime frame
Severe asthma exacerbations, pulmonary function test data, and a change in symptomsMeasured over the duration of the trial.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026