Investigating Dupilumab's Effect in Asthma by Genotype (IDEA)
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| ClinicalTrials.gov Identifier: NCT03694158 |
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Recruitment Status :
Recruiting
First Posted : October 3, 2018
Last Update Posted : May 30, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Dupilumab Other: Placebo | Phase 4 |
This is a double-blind, randomized, placebo-controlled parallel-group phase 4 clinical trial.
Patients will be genotyped and categorized as those with: 1) the wild type allele (Q576/Q576), 2) heterozygous allele (Q576/R576), or 3) homozygous mutant allele (R576/R576); the genotype associated with more severe disease.
After a run-in period of 2-12 weeks to determine asthma control, subjects who fulfill all inclusion/exclusion criteria will be randomized to receive either subcutaneous Dupilumab or placebo (1:1 randomization allocation ratio).
This study addresses fundamental mechanisms by which the IL-4Rα-R576 variant drives the TH2/TH17 disease endotype and the influence of this variant on response to Dupilumab therapy. It brings together individuals with deep clinical and scientific expertise in allergic diseases, including epidemiology, genetics, inflammation, and tolerance mechanisms to investigate, in a coordinated strategy, the hypothesis that the IL-4Rα-R576 variant drives TH2/TH17 cell inflammation by subverting allergen-specific iTreg cells into TH17 cells. Asthmatics bearing this endotype will be particularly likely to favorably respond to Dupilumab therapy by virtue of its prevention of iTreg cell reprogramming into TH17-like cells, potentially leading to their long-term stability and potential for sustained immune tolerance.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a genotype stratified, double-blind, randomized, placebo-controlled, parallel-group, phase IV clinical trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double blind, placebo controlled. |
| Primary Purpose: | Treatment |
| Official Title: | Effect of IL-4RαR576 Polymorphism on Response to Dupilumab in Asthma, a Genotype-stratified, Randomized, Placebo- Controlled Trial |
| Actual Study Start Date : | September 8, 2021 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | March 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment group
Dupilumab (Dupixent®) administered subcutaneously every two weeks. An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week.
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Drug: Dupilumab
anti-IL4 receptor antagonist
Other Name: Dupixent® |
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Placebo Comparator: Placebo group
Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two weeks.
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Other: Placebo
Placebo for Dupilumab (packaged/administered the same as the active drug) |
- The rate of asthma exacerbations [ Time Frame: 48 week treatment period ]An exacerbation is an asthma attack for which a clinician prescribed a course of systemic steroids, whether or not the patient took the steroids.
- Change in pre-bronchodilator lung function [ Time Frame: average of week 4,12, 24,36 and 48 week ]the change in pre-bronchodilator FEV1% predicted from baseline
- Change in CASI score [ Time Frame: average of 4,12, 24, 36, and 48 week ]The change in CASI score from baseline
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 12 years and older
- Ability to provide informed consent
- Ability to perform pulmonary function tests
- Female participants of childbearing potential must have a negative urine pregnancy test upon study entry
- Female participants with reproductive potential must agree to use FDA-approved methods of birth control for the duration of the study2
- Participant-reported physician or licensed medical practitioner diagnosis of asthma
- Treatment with medium to high dose ICS (400 mcg to maximum of 2000 mcg per day of fluticasone propionate or equivalent) for at least 3 months with a stable dose ≥1 month prior to screening OR used a biologic medication for asthma within the past 8 weeks
- History of asthma exacerbation in the past year
An exacerbation is an asthma attack for which a clinician prescribed a course of systemic (oral, IV, IM) steroids whether or not the patient took the steroids OR An increase of >50% of baseline inhaled corticosteroid dose for ≥3 days OR An unscheduled visit for acute asthma attack (licensed medical practitioner/nurse office, urgent care intervention, emergency department, or hospitalization)
Exclusion Criteria:
- Chronic lung disease other than asthma, which may impair lung function
- Current smoker or cessation of smoking ≤6 months prior to Visit 0 screening
- Current use of any electronic (e) "vaping" device (e.g., e-cigarette, e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods) or cessation ≤ 6 months prior to screening
- Pregnant or breast feeding
- Any other condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or quality of data
- Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures
- Planning to relocate away from the clinical center area before study completion
- Currently participating in an investigational drug trial or participated in one within 30 days before screening
- Currently being treated with immunosuppressive/immunomodulatory or other investigational agents or biologics for conditions other than asthma, or used a biologic for a non-asthma indication within the past 6 months
- History of respiratory illness requiring antibiotics or systemic corticosteroids, including asthma exacerbations, within the past 4 weeks (evaluated at time of screening visit)
- History of alcohol or illicit substance abuse within 6 months of screening
- Neutropenia (<1,000/mm3) or thrombocytopenia (<100,000/mm3) or hemoglobin < 100 g/L (10 g/dL) or blood eosinophils > 1500/mm3 at screening
- Administration of a live vaccine within 4 weeks of screening
- Currently receiving allergen immunotherapy (food or aeroallergen) other than an established maintenance regimen implemented continuously for a minimum of 2 months. Individuals receiving aeroallergen immunotherapy must be willing to stay on it for the duration of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694158
| Contact: Wanda Phipatanakul, MD, MS | 857-218-5336 | Wanda.Phipatanakul@childrens.harvard.edu | |
| Contact: Claudina Luna | asthma@childrens.harvard.edu |
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Claudina Luna, MD. MPH. 857-218-5336 asthma@childrens.harvard.edu | |
| Principal Investigator: Wanda Phipatanakul, MD.MS. | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Angeles Cinelli mcinelli@bwh.harvard.edu | |
| Principal Investigator: Eliot Israel, MD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Sherae Hereford, RN 313-207-2453 sherefo3@hfhs.org | |
| Principal Investigator: Haejin Kim, MD. | |
| United States, New Jersey | |
| Atlantic Health System | Recruiting |
| Cedar Knolls, New Jersey, United States, 07927 | |
| Contact: Juliana Colecchia 908-934-0555 ext 78625 Juliana.colecchia@atlantichealth.org | |
| Principal Investigator: John Oppenheimer, MD | |
| United States, New York | |
| Montefiore Einstein Clinical Research Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Samuel Green 718-920-7777 sagreen@montefiore.org | |
| Contact: Sunit Jariwala, MD 609-937-1023 SJARIWAL@montefiore.org | |
| Principal Investigator: Sunit Jariwala, MD. | |
| United States, Ohio | |
| MetroHealth System | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: David Kaelber, MD.PHD. MPH. 216-780-3722 dkaelber@metrohealth.org | |
| Contact: Kimberly Schach 216-778-7992 kschach@metrohealth.org | |
| Principal Investigator: David Kaelber, MD.PHD.MPH. | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Elizabeth Beothy 215-549-5023 eabeothy@pennmedicine.upenn.edu | |
| Contact: Audreesh Banerjee, MD 215-549-5023 Audreesh.Banerjee@pennmedicine.upenn.edu | |
| Principal Investigator: Audreesh Banerjee, MD | |
| Principal Investigator: | Wanda Phipatanakul | Boston Children's Hospital |
| Responsible Party: | Wanda Phipatanakul, Professor of Pediatrics, Boston Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT03694158 |
| Other Study ID Numbers: |
P00029072 U01AI143514 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 3, 2018 Key Record Dates |
| Last Update Posted: | May 30, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |