SWIFT-2: Placebo-controlled efficacy and safety study of GSK3511294 (depemokimab) in participants with severe asthma with an eosinophilic phenotype

About this Study

The purpose of this study to assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in patients with severe uncontrolled asthma with an eosinophilic phenotype.

Sponsor Protocol ID:213744
IRB Number:0000000
Actively Enrolling
Interventional
Phase 3
November 10, 2022
Eligibility Criteria
12 years old
Both Male and Female
No
No
No

Inclusion Criteria
  • Adults and adolescents greater than or equal than 12 years of age, at the time of informed consent/assent
  • Patients must have documented physician diagnosis of asthma for greater than or equal to 2 years AND eosinophilic phenotype AND exacerbation history
  • Airflow obstruction
  • A well-documented requirement for regular treatment with medium to high dose ICS
  • Current treatment with at least one additional controller medications, beside ICS, for at least 3 months
  • Male or female

Exclusion Criteria
  • Presence of a known pre-existing, clinically important lung condition other than asthma
  • Other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes¬†
  • Known, pre-existing parasitic infestation within 6 months prior Visit 1
  • Known immunodeficiency, such as HIV
  • Current malignancy or previous history of cancer in remission for less than 12 months prior to screening
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence ascites, encephalopathy,¬†
  • Known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic
  • Current diagnosis of vasculitis
  • Active COVID
  • Receiving monoclonal antibodies targeting IL-5/5R, other mAbs in the treatment of asthma, treatment with investigational drug within the past 30 days
  • Current smoker or former smoker with a smoking history of greater than 10 pack years

Categories Click category to view its trials.
Allergy/Asthma/Immunology
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Jamie Brown
Phone Number: 601-496-7815
Email: jlbrown@umc.edu
Principal Investigator:Marshall, Gailen D, M.D., Ph.D.
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