Itepekimab for Bronchiectasis

Not currently recruiting at 217 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Antimicrobials, Immunosuppressants

Disqualifiers: Cystic fibrosis, Immunodeficiency, Tuberculosis, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24-52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, itepekimab, to determine its effectiveness for people with bronchiectasis, a lung condition causing excessive coughing and mucus. Participants will receive either itepekimab or a placebo to compare the drug's efficacy and safety. The study seeks individuals who have experienced bronchiectasis symptoms, such as coughing and mucus buildup, along with at least two moderate or one severe lung infection in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatment for tuberculosis, allergic bronchopulmonary aspergillosis, or using immunosuppressive therapy for autoimmune disease, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that itepekimab, a treatment targeting the protein IL-33, holds promise for conditions such as asthma and COPD (chronic obstructive pulmonary disease). In studies with asthma patients, itepekimab improved asthma control and quality of life compared to a placebo. Importantly, these studies found that itepekimab was well-tolerated, with most participants experiencing no serious side effects. While every treatment can have some side effects, current evidence suggests itepekimab is generally safe for humans. This supports its continued testing in new conditions like bronchiectasis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Itepekimab is unique because it targets the IL-33 pathway, which is a new approach compared to the current treatments for bronchiectasis that mainly focus on managing symptoms with antibiotics, bronchodilators, and airway clearance techniques. Researchers are excited about Itepekimab because it has the potential to address the underlying inflammation and immune response in bronchiectasis, rather than just alleviating symptoms. This could lead to a more effective management of the disease and improve the quality of life for patients by reducing flare-ups and lung damage over time.

What evidence suggests that this trial's treatments could be effective for bronchiectasis?

Research has shown that itepekimab may improve asthma control and quality of life. In earlier studies, patients using itepekimab achieved better results in lowering blood eosinophil counts, which are linked to inflammation in asthma. This suggests it might also reduce inflammation in conditions like bronchiectasis. In this trial, participants will receive itepekimab every 2 weeks or every 4 weeks, or a placebo. Additionally, studies have reported improvements in symptoms and fewer flare-ups. These findings provide strong evidence for exploring itepekimab's potential benefits in treating bronchiectasis. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with non-cystic fibrosis bronchiectasis (NCFB), who've had at least 2 moderate or 1 severe lung flare-up in the past year. They should have symptoms like cough, mucus, or frequent infections and a certain level of lung function.

Inclusion Criteria

I have had 2 moderate or 1 severe lung flare-up in the last year.

Participants with a FEV1 % predicted ≥30%

I often cough, produce sputum, or get lung infections.

Exclusion Criteria

I have had cancer within the last 5 years.

History of lung transplantation

Known or suspected immunodeficiency disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

Treatment

Participants receive either itepekimab or placebo with dosing regimens of every 2 or 4 weeks for up to 52 weeks

24-52 weeks

Monthly site/phone visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Monthly site/phone visits

What Are the Treatments Tested in This Trial?

Interventions

• Itepekimab

Trial Overview The study compares two doses of Itepekimab (an experimental drug) against a placebo to see which is better for NCFB. Participants are randomly assigned to one of three groups and will be monitored through visits or calls each month for up to about a year and a half.

How Is the Trial Designed?

Group I: Itepekimab Q4W Experimental Treatment 2 Interventions

SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks

Group II: Itepekimab Q2W Experimental Treatment 1 Intervention

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Group III: Placebo Placebo Group 1 Intervention

SC administration of matching placebo Q2W for up to 52 weeks

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

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

Published Research Related to This Trial

Allergic bronchopulmonary aspergillosis (ABPA) is often underdiagnosed in asthmatic and cystic fibrosis patients, leading to recurrent respiratory issues that typically respond to corticosteroid treatment.

Long-term corticosteroid use can have adverse effects, prompting interest in antifungal treatments like itraconazole, which may serve as a corticosteroid-sparing option, especially for patients with poor response to corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of allergic bronchopulmonary aspergillosis. Vlahakis, NE., Aksamit, TR.[2013]

Itepekimab, a monoclonal antibody targeting interleukin-33, was found to be safe and well-tolerated in two phase I studies involving 63 participants, with no treatment-emergent anti-drug antibody responses detected.

The drug demonstrated effective pharmacokinetics with a long half-life and significant effects on reducing IL-33 levels and blood eosinophils, indicating its potential to reduce airway inflammation in asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Kosloski, MP., Kalliolias, GD., Xu, CR., et al.[2022]

In a phase 2a trial involving 343 patients with moderate-to-severe COPD, itepekimab did not significantly reduce the overall rate of acute exacerbations compared to placebo, but showed promising results in former smokers, with a 42% reduction in exacerbation rates and improved lung function.

Genetic analyses indicated that certain IL-33 pathway variants are associated with COPD risk, suggesting a potential mechanism for how itepekimab may work, particularly in patients with specific genetic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. Rabe, KF., Celli, BR., Wechsler, ME., et al.[2022]

In a study of 14 asthmatic patients with allergic bronchopulmonary aspergillosis (ABPA), treatment with itraconazole for at least 12 months led to significant clinical improvements, including increased pulmonary function and reduced blood eosinophilia and serum IgE levels.

Itraconazole also allowed for a reduction in the use of oral glucocorticoids, with 7 out of 14 patients able to completely stop glucocorticoid therapy, highlighting its potential as an effective alternative treatment for ABPA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of itraconazole therapy in allergic bronchopulmonary aspergillosis. Salez, F., Brichet, A., Desurmont, S., et al.[2019]

In a phase 2 trial involving 296 adults with moderate-to-severe asthma, itepekimab, a monoclonal antibody targeting interleukin-33, significantly reduced the incidence of asthma control loss compared to placebo, with 22% of patients experiencing loss of control versus 41% in the placebo group.

Itepekimab also improved lung function and quality of life, while showing a similar safety profile to other treatments, indicating its potential as an effective new therapy for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma. Wechsler, ME., Ruddy, MK., Pavord, ID., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06280391

NCT06280391 | A Proof-of-Concept Study to Assess the ... The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female ...

2. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-05-30-05-00-00-3090818

Press Release: Itepekimab met the primary endpoint in one ... In AERIFY-2, the overall rates of AEs were 64% and 71% for itepekimab every two weeks and every four weeks, respectively, compared to 64% for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11287337/

Pharmacokinetics and pharmacodynamics of itepekimab in ... In the dose‐ranging study, mean percent change from baseline in EASI score at Week 16 was −33.5% (n = 10) in placebo, and −57.9% (n = 7), −52.7% ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2024257

Efficacy and Safety of Itepekimab in Patients with Moderate ... Itepekimab treatment improved asthma control and quality of life, as compared with placebo, and led to a greater reduction in the mean blood eosinophil count.

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2578/proof-of-concept-study-assess-efficacy/

A Proof-of-Concept Study to Assess the Efficacy Safety and ... This study aims to evaluate the safety, efficacy, and tolerability of itepekimab in patients with bronchiectasis, in addition to their current treatment ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34302758/

Safety and efficacy of itepekimab in patients with moderate- ... Itepekimab, a monoclonal antibody targeting IL-33, demonstrated clinical activity in asthma, with potential in chronic obstructive pulmonary ...

7. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019UHEAY/nct06280391

REGENERON - Clinical Trials The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female ...