AsthmaNCT03020810
Dupilumab Compassionate Use Study
A study testing Dupilumab in people with Asthma, run by Sally E. Wenzel MD.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Sever systemic corticosteroid dependent asthma for more than 5 years
Who cannot join
- 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.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sally E. Wenzel MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally E. Wenzel MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020810
- Sponsor's protocol ID
- PRO16120334
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab Compassionate Use Study
- ClinicalTrials.gov ID
- NCT03020810
- Acronym / sponsor ID
- PRO16120334
- Conditions
- Asthma
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Sally E. Wenzel MDUniversity, hospital or other
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sever systemic corticosteroid dependent asthma for more than 5 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabThe patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dupilumab in people with Asthma, run by Sally E. Wenzel MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.