Brensocatib for Bronchiectasis

(ASPEN Trial)

Recruiting at 565 trial locations

Overseen By Insmed Medical Information

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Insmed Incorporated

Must not be taking: Prohibited medications

Disqualifiers: COPD, Asthma, Cystic fibrosis, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1767 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called brensocatib in two doses (10 mg and 25 mg) to see if it can reduce lung flare-ups. The study focuses on patients who often have worsening lung symptoms. The goal is to see if brensocatib can help these patients have fewer severe lung problems.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that some medications or therapies are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.

What makes the drug Brensocatib unique for treating bronchiectasis?

Brensocatib is unique because it is a first-in-class drug that selectively and reversibly inhibits dipeptidyl peptidase 1, which blocks the activation of enzymes called neutrophil serine proteases that contribute to lung inflammation and damage in bronchiectasis. Unlike other treatments, it has shown promise in reducing lung inflammation and prolonging the time to worsening of symptoms in patients with non-cystic fibrosis bronchiectasis. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adolescents and adults with non-cystic fibrosis bronchiectasis, confirmed by CT scan, who've had at least one lung infection needing antibiotics in the past year. Participants must be able to consent and follow study procedures. Pregnant women or those of childbearing potential must use effective contraception.

Inclusion Criteria

I have a lung condition confirmed by a CT scan, not related to cystic fibrosis.

I have needed antibiotics for respiratory infections at least twice in the last year.

I am a teenager and have had at least one lung flare-up in the last year.

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks.

Inability to follow the procedures of the study (eg, due to language problems or psychological disorders)

Participated in any other interventional clinical studies within 3 months before Screening Visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brensocatib or placebo once daily for 52 weeks to evaluate the effect on pulmonary exacerbations

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brensocatib
• Placebo

Trial Overview The trial tests brensocatib's effectiveness at two doses (10 mg and 25 mg) versus a placebo in reducing lung infections over a year. It aims to see if brensocatib can lower the frequency of these exacerbations compared to not taking the drug.

Participant Groups

Group I: Brensocatib 25 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.

Group II: Brensocatib 10 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials

44

Recruited

7,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of brensocatib for treatment of non-cystic fibrosis bronchiectasis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Periodontal Effects of the Reversible Dipeptidyl Peptidase 1 Inhibitor Brensocatib in Bronchiectasis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Dipeptidyl peptidase-1 inhibition with brensocatib reduces the activity of all major neutrophil serine proteases in patients with bronchiectasis: results from the WILLOW trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Bronchiectasis insanity: Doing the same thing over and over again and expecting different results? [2020]