Trials / Approved For Marketing
Approved For MarketingNCT03020810
Dupilumab Compassionate Use Study
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Sally E. Wenzel MD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- First posted
- 2017-01-13
- Last updated
- 2018-03-07
Source: ClinicalTrials.gov record NCT03020810. Inclusion in this directory is not an endorsement.