Recruiting

Dupilumab

Sponsor:

Sally E. Wenzel MD

Code:

NCT04743791

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Placebo

Study Details

Brief summary:

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

Conditions

Asthma

Study ID

NCT04743791

Start date

Oct 17, 2022

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
  • Age > 18
  • Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
  • Reversibility >/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
  • FEV1/Forced Vital Capacity (FVC)<75%
  • Blood Eosinophils (EOS) >300 cells per mm3
  • Exhaled Nitric Oxide (FeNO) >25 parts per billion (ppb)
  • Asthma Control Test (ACT) score <20

Exclusion Criteria:

  • Pregnant, nursing, or unwilling to test for pregnancy
  • Current smoker or >10 pack year smoking history
  • Body Mass Index (BMI)>37
  • Respiratory infection in the last 30 days
  • Use of antibiotics or oral prednisone in the last 30 days
  • Current or previous use of dupilumab
  • Current or recent use of anti-IL-5 therapies
  • Any other criteria that place the subject at unnecessary risk
  • Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
  • History of non-skin cell cancer in the last 5 years
  • Drug or alcohol addiction in the last 5 years
  • Any other uncontrolled disease

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dupilumab

Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.

placebo comparator: Placebo

Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.

Interventions

Dupilumab

Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.

Placebo

Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).

Primary outcome measure

  • Change in mucociliary clearance (MCC) rate [ Time Frame: Measured at 12 weeks after the start of treatment ]

Central Contacts and Locations

Central contacts

John Moore

412-648-6726mooreja6@upmc.edu

Locations

The University of Pittsburgh Asthma Institute at UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sally Wenzel, MD

412-647-9955swenzel@pitt.edu

John Moore

412-648-6726mooreja6@upmc.edu

More Information

Sponsor

Sally E. Wenzel MD

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sally E. Wenzel MD on 2026-08-06.