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Anti-inflammatory

Brensocatib for Cystic Fibrosis

Phase 2
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; day 28: predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose
Awards & highlights

Study Summary

This trial is testing a new drug for cystic fibrosis to see how well it is tolerated and how it affects the body.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; day 28: predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; day 28: predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) of Brensocatib
Elimination Half-life (t1/2) of Brensocatib
Maximum Plasma Concentration (Cmax) of Brensocatib
+2 more
Secondary outcome measures
Dose-normalized Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) of Brensocatib
Dose-normalized Area Under the Concentration-time Curve from Time 0 to the Time of Last Measurable Concentration (AUClast) of Brensocatib
Dose-normalized Maximum Plasma Concentration (Cmax) of Brensocatib

Side effects data

From 2021 Phase 3 trial • 406 Patients • NCT04817332
14%
Infections
4%
Respiratory disorders
3%
Rash
2%
Nausea
2%
Hyperglycaemia
2%
Dyspepsia
2%
Nervous system disorders
2%
Epistaxis
2%
Dizziness
1%
Pruritus
1%
Peripheral swelling
1%
Glossodynia
1%
Oedema peripheral
1%
Extravasation
1%
Hepatic function abnormal
1%
Swollen tongue
1%
Dyspnoea
1%
Supraventricular tachycardia
1%
Vomiting
1%
Constipation
1%
Gastrooesophageal reflux disease
1%
Arthralgia
1%
Serratia infection
1%
Hallucination, visual
1%
Nightmare
1%
Respiratory tract infection
1%
Gastrointestinal disorders
1%
Gastritis erosive
1%
General disorders
1%
Skin disorders
1%
Vascular disorders
1%
Chronic lymphocytic leukaemia
1%
Peripheral ischaemia
1%
Chest discomfort
1%
Swelling face
1%
Hiccups
1%
Pneumothorax
1%
Rhinorrhoea
1%
Pulmonary embolism
1%
Alanine aminotransferase increased
1%
Liver function test abnormal
1%
Glycosylated haemoglobin increased
1%
Blood glucose abnormal
1%
Transaminases increased
1%
Fall
1%
Bradycardia
1%
Palpitations
1%
Tachyarrhythmia
1%
Acute coronary syndrome
1%
Sinus bradycardia
1%
Headache
1%
Memory impairment
1%
Paraesthesia
1%
Vision blurred
1%
Dry mouth
1%
Gingival bleeding
1%
Hypoaesthesia oral
1%
Lip pain
1%
Mouth ulceration
1%
Subcutaneous emphysema
1%
Dry skin
1%
Rash pruritic
1%
Acute kidney injury
1%
Back pain
1%
Muscle spasms
1%
Clostridium difficile colitis
1%
Candida infection
1%
Pneumonia
1%
Urinary tract infection
1%
Staphylococcal bacteraemia
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brensocatib
Placebo

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Brensocatib 65 mgExperimental Treatment1 Intervention
Following review of safety and pharmacokinetic data by the safety review committee, an additional cohort of participants may be administered brensocatib at a dose of 65 mg once per day for 28 days. The participants will be stratified based on CFTRs modulator treatment.
Group II: Brensocatib 40 mgExperimental Treatment1 Intervention
Participants will be administered brensocatib at a dose of 40 mg once per day for 28 days. The participants will be stratified based on CFTRs modulator treatment.
Group III: Brensocatib 25 mgExperimental Treatment1 Intervention
Participants will be administered brensocatib at a dose of 25 mg once per day for 28 days. The participants will be stratified based on CFTRs modulator treatment.
Group IV: Brensocatib 10 mgExperimental Treatment1 Intervention
Participants will be administered brensocatib at a dose of 10 mg once per day for 28 days. The participants will be stratified based on cystic fibrosis transmembrane conductance regulators (CFTRs) modulator treatment.
Group V: PlaceboPlacebo Group1 Intervention
Participants will be administered a placebo matching brensocatib once per day for 28 days. The participants will be stratified based on CFTRs modulator treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,173 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
682 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior experiments have been performed concerning the efficacy of Brensocatib?

"In 2020, the first human trial of Brensocatib was conducted at ESP006. To date, a total of 18327 studies have been concluded and two trials are currently being performed in Northfield, Illinois."

Answered by AI

How many participants are involved in this experiment?

"To meet the objectives of this medical trial, 34 volunteers that satisfy strict enrolment requirements must take part. Those eligible can sign up at USA025 in Northfield, Illinois or USA017 in Nashville, Tennessee among other locations."

Answered by AI

Does this experiment set a precedent for similar initiatives?

"Research into Brensocatib began in 2020, courtesy of Insmed Incorporated. Following the commencement of a 1620-person study that same year, this drug was given Phase 3 approval. Subsequent to these events there are two active trials featuring Brensocatib across 305 cities and 38 nations worldwide."

Answered by AI

Has Brensocatib received official clearance from the FDA?

"Although there is preliminary evidence to support the safety of Brensocatib, it has not been proven efficacious and was thus given a score of 2."

Answered by AI

Are there currently vacancies in this experiment for participants?

"Affirmative. The information hosted on clinicaltrials.gov attests that this medical trial is currently recruiting participants, with a posting date of November 30th 2021 and the most recent update made on November 10th 2022. This study seeks to engage 34 patients from 26 separate sites."

Answered by AI

How many locales are hosting this trial?

"This medical study is taking place in 26 distinct sites, which span from Northfield to Boston and include a selection of other cities. To reduce any burden relating to travel, it may be helpful for prospective participants to select the site closest them."

Answered by AI

Who else is applying?

What site did they apply to?
USA002
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
2021. "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05090904.
~9 spots leftby Apr 2025
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