RecruitingPhase 3NCT07309614

A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma

A Multinational, Investigator-initiated, Parallel Group, Randomised, Double-blind, Placebo-controlled Phase 3b Superiority Trial Assessing the Effect of Dupilumab on Inducing Clinical Remission Outcomes in At-risk Type-2 Inflammatory Asthma (HOTHOT)


Sponsor

Université de Sherbrooke

Enrollment

150 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called "remission") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage. This study explores whether treating high-risk patients earlier could prevent asthma attacks and lung function decline, potentially achieving remission before permanent damage occurs. The study is looking for adults aged 18-79 with moderate asthma who have had at least one asthma attack requiring steroid pills in the past 2 years, use medium or high-dose inhaled steroids regularly, have high levels of inflammation markers in their blood and breath tests, but don't yet meet criteria for severe asthma requiring biologic therapy. Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications. They attend clinic visits every 3 months for breathing tests, questionnaires, and safety monitoring. Neither participants nor doctors know who receives the real medication until the study ends. The goal is to learn whether early treatment with dupilumab helps more people achieve complete asthma control compared to standard care alone, potentially changing how asthma is treated from "waiting until severe" to "preventing severe disease." The study runs in Canada, the United Kingdom, and Australia, involving 150 participants


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether dupilumab — a medication already used for eczema and other allergic conditions — can help bring asthma into full remission (meaning symptoms are completely controlled and medications can eventually be reduced or stopped). **You may be eligible if...** - You are between 18 and 79 years old - You have had a doctor's diagnosis of asthma for at least 6 months - Your asthma has been confirmed with breathing tests showing variable airflow - You have moderate-to-severe asthma that is not fully controlled **You may NOT be eligible if...** - You do not have confirmed asthma based on medical criteria - You have another lung condition that may be causing your symptoms - You are on medications or have conditions that conflict with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab Prefilled Syringe

Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks

DRUGPlacebo Injection

Volume-matched placebo injected subcut every 2 weeks


Locations(5)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

McGill University Health Centre

Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

CIUSSS de l'Estrie- CHUS

Sherbrooke, Quebec, Canada

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07309614


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