Investigating Dupilumab's Effect in Asthma by Genotype (IDEA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03694158|
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : August 20, 2021
|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|
|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.|
|Official Title:||Effect of IL-4RαR576 Polymorphism on Response to Dupilumab in Asthma, a Genotype-stratified, Randomized, Placebo- Controlled Trial|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||March 2024|
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.
anti-IL4 receptor antagonist
Other Name: Dupixent®
Placebo Comparator: Placebo group
Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two weeks.
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
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: Amparito Cunninghamfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: Amparito Cunningham, MD. MPH. 857-218-5531 Amparito.Cunningham@childrens.harvard.edu|
|Contact: Conor Brockway 857-218-3819 email@example.com|
|Principal Investigator: Wanda Phipatanakul, MD.MS.|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: Angeles Cinelli firstname.lastname@example.org|
|Principal Investigator: Eliot Israel, MD|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|Contact: Sherae Hereford, RN 313-207-2453 email@example.com|
|Principal Investigator: Haejin Kim, MD.|
|United States, New Jersey|
|Atlantic Health System|
|Cedar Knolls, New Jersey, United States, 07927|
|Contact: Beverly Obipso 908-934-0555 ext 78625 Beverly.Obispo@atlantichealth.org|
|Principal Investigator: John Oppenheimer, MD|
|Principal Investigator:||Wanda Phipatanakul||Boston Children's Hospital|