Dupilumab for Aspirin-exacerbated Respiratory Disease

NCT03595488 | Completed Phase 2 FDA Drug

• 1 other identifier: 1828-A-18
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score \> 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.

Conditions

Aspirin-exacerbated Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• SNOT 22 Score

  This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis

  From baseline to completion of study(7 months total)

Secondary Outcomes (14)

• UPSIT

  From baseline to completion of study( 7 months total)

• Lund Mackay score

  From baseline to completion of study( 7 months total)

• ACT score

  From baseline to completion of study( 7 months total)

• Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions.

  From baseline to completion of study( 7 months total)

• Change in FEV1

  From baseline to completion of study( 7 months total)

Study Arms (1)

Treatment arm

EXPERIMENTAL

Single-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home. 300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection

Drug: Dupilumab

Interventions

Dupilumab DRUG

dupilumab 300 mg subcutaneous injection every 2 weeks

Also known as: Matching placebo

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
• All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
• Able to understand and willingness to sign informed consent
• Able to comply with study procedures

You may not qualify if:

• Patient \< 18 years of age
• Pregnancy or breast feeding
• Current tobacco use
• Significant, uncontrolled medical conditions
• Ongoing malignancy or history of malignancy in remission within the past 12 months
• Current treatment with immunosuppressive medications except chronic oral steroids
• Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
• Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment

Sponsors & Collaborators

• Rochester General Hospital: lead

Study Sites (1)

Rochester Regional Health - Allergy/Immunology

Rochester, New York, 14607, United States

Location

Related Publications (27)

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MeSH Terms

Interventions

dupilumab

Study Officials

• S Shahzad Mustafa, MD

  Lead Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 23, 2018
• Study Start: September 5, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)