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Dupilumab Compassionate Use Study

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ClinicalTrials.gov Identifier: NCT03020810
Recruitment Status : Approved for marketing
First Posted : January 13, 2017
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Sally E. Wenzel MD, University of Pittsburgh

Brief Summary:
This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

Condition or disease Intervention/treatment
Asthma Drug: Dupilumab

Detailed Description:

This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.

The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

Study Type : Expanded Access
Official Title: Dupilumab Compassionate Use Study

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab
U.S. FDA Resources

Intervention Details:
    Drug: Dupilumab
    The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Sever systemic corticosteroid dependent asthma for more than 5 years

Exclusion Criteria:

  • Disease other than asthma
  • Circulation eosinophils more than 1500/ul
  • Current smoker or more than 10 pack years

This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.

No Contacts or Locations Provided

Responsible Party: Sally E. Wenzel MD, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03020810     History of Changes
Other Study ID Numbers: PRO16120334
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs