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Dupilumab Compassionate Use Study

Dupilumab Compassionate Use Study

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03020810
Enrollment
Unknown
Registered
2017-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2018-03-07

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

Conditions

Asthma

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.

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.

Interventions

DRUGDupilumab

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

Sponsors

Sally E. Wenzel MD
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Outcome results

None listed

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