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NCT03020810 Clinical Trial

Dupilumab Compassionate Use Study

Asthma Clinical Trial

Official title:
Dupilumab Compassionate Use Study

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03020810
Other study ID # PRO16120334
Secondary ID
Status Approved for marketing
Phase N/A
First received January 11, 2017
Last updated March 5, 2018

Study information
Verified date March 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sally E. Wenzel MD
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