Dupilumab Compassionate Use Study

NCT ID: NCT03020810

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Asthma

Interventions

Dupilumab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sally E. Wenzel MD

OTHER

Sponsor Role: lead

Responsible Party

Sally E. Wenzel MD

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

PRO16120334

Identifier Type: -

Identifier Source: org_study_id