NCT03020810

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

First QC Date

January 11, 2017

Last Update Submit

March 5, 2018

Conditions

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sever systemic corticosteroid dependent asthma for more than 5 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Last Updated

March 7, 2018

Record last verified: 2018-03