Dupilumab for Asthma
(HOTHOT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether the asthma medication dupilumab can help individuals gain full control over their asthma symptoms when used earlier in disease progression. Currently, advanced treatments are typically administered only after the condition becomes severe. The research aims to determine if starting treatment sooner can prevent asthma attacks and lung damage. Suitable candidates have moderate asthma, have experienced an asthma attack requiring steroid pills in the past two years, regularly use medium or high-dose inhaled steroids, and have high inflammation markers. Participants will receive either dupilumab or a placebo injection every two weeks for a year, alongside their regular asthma medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in asthma treatment.
Will I have to stop taking my current medications?
No, you can continue taking your regular asthma medications while participating in the trial.
Is there any evidence suggesting that dupilumab is likely to be safe for humans?
Research has shown that dupilumab, a medication for asthma, is generally safe and well-tolerated by patients. Recent studies found that people using dupilumab for up to three years continued to do well with the treatment. The safety results aligned with existing knowledge about dupilumab. Additionally, those who took dupilumab experienced fewer severe asthma attacks compared to those who took a placebo (a treatment with no active medicine).
Overall, these findings suggest that dupilumab is a safe choice for managing asthma, especially when started early in the disease. This could help prevent severe symptoms and improve overall asthma control.12345Why do researchers think this study treatment might be promising?
Dupilumab is unique because it targets the inflammatory pathways in asthma by blocking the IL-4 and IL-13 signaling pathways. Most standard asthma treatments, like inhaled corticosteroids and beta-agonists, primarily focus on relieving symptoms or reducing inflammation in a more general way. By specifically targeting these cytokines, Dupilumab offers a more precise approach, potentially reducing the frequency and severity of asthma attacks. Researchers are excited because this targeted mechanism could lead to better control of asthma symptoms with fewer side effects, improving the quality of life for those with difficult-to-treat asthma.
What evidence suggests that dupilumab might be an effective treatment for asthma?
Research has shown that dupilumab, which participants in this trial may receive, can help treat asthma. In one study, 75% of people taking dupilumab had better control of their asthma compared to 67% of those taking a placebo, indicating a noticeable improvement. Another study found that people on dupilumab experienced fewer severe asthma attacks than those who did not take it. Additionally, 30% of patients achieved complete control of their asthma after 12 months on dupilumab. These findings suggest that dupilumab could be a promising option for managing asthma more effectively, especially if used early.13567
Are You a Good Fit for This Trial?
Adults aged 18-79 with moderate asthma, who've had an asthma attack requiring steroids in the past 2 years, use regular inhaled steroids, and show high inflammation but don't need severe asthma treatment yet. They must pass certain breathing tests showing variability or reactivity in lung function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Trial Overview
The trial is testing if early treatment with dupilumab injections every two weeks can induce remission in moderate asthma patients compared to a placebo. The study involves regular clinic visits for tests and monitoring without knowing who gets the real drug until the end.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Université de Sherbrooke
Lead Sponsor
University of Oxford
Collaborator
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
The University of Western Australia
Collaborator
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Fonds de la Recherche en Santé du Québec
Collaborator
Association Pulmonaire du Quebec
Collaborator
Citations
Long-term outcomes of dupilumab therapy in severe asthma
Of patients who continued dupilumab, 30% achieved remission at 12 months, and 26% achieved remission at 36 months. Of the 65 patients who ...
Long-term outcomes of dupilumab therapy in severe asthma
Conclusions. Dupilumab represents an effective long-term treatment option for patients with severe asthma, with sustained treatment effects up to 36 months.
Efficacy and Safety Overview
75% of patients had improved ACQ-5 (asthma control) scores with DUPIXENT 200 mg Q2W + SOC vs 67% with placebo + SOC (OR: 1.46 [95% CI: 0.90, 2.35]) (baseline ...
Dupilumab Efficacy and Safety in Moderate-to-Severe ...
In this trial, patients who received dupilumab had significantly lower rates of severe asthma exacerbation than those who received placebo, as well as better ...
FINDINGS FROM THE US ADVANTAGE STUDY
The US ADVANTAGE study demonstrated real-world effectiveness of dupilumab in reducing asthma exacerbation among patients 12 years and older in US clinical ...
Long-Term Safety of Dupilumab in Patients With Moderate- ...
Conclusions: Dupilumab treatment was well tolerated for up to an additional 3 years. Safety findings were consistent with the known safety profile of dupilumab.
Efficacy and safety of dupilumab as add-on therapy for ...
This real-world study indicates that dupilumab in SA leads to less asthma exacerbations, decreased oral corticosteroid use, and better asthma control.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.