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Anti-inflammatory
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With 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 up to 5 years
Summary
This trial tests brensocatib, a daily pill, in people with cystic fibrosis. It aims to see how the drug moves through their bodies and if it is safe. The study compares brensocatib to another group over a few weeks.
Eligible Conditions
- Cystic Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2021 Phase 3 trial • 406 Patients • NCT0481733214%
Infections
4%
Respiratory disorders
3%
Rash
2%
Dizziness
2%
Dyspepsia
2%
Nausea
2%
Hyperglycaemia
2%
Nervous system disorders
2%
Epistaxis
1%
Respiratory tract infection
1%
Glossodynia
1%
Gastrooesophageal reflux disease
1%
Fall
1%
Mouth ulceration
1%
Hypokalaemia
1%
Clostridium difficile colitis
1%
Pneumonia
1%
Palpitations
1%
Candida infection
1%
Dry mouth
1%
Sinus bradycardia
1%
Constipation
1%
Swollen tongue
1%
Pruritus
1%
Subcutaneous emphysema
1%
Tachyarrhythmia
1%
Hepatic function abnormal
1%
Bradycardia
1%
Headache
1%
Vomiting
1%
Gastritis erosive
1%
Dry skin
1%
Muscle spasms
1%
Gingival bleeding
1%
Alanine aminotransferase increased
1%
Glycosylated haemoglobin increased
1%
Paraesthesia
1%
Vision blurred
1%
Hypoaesthesia oral
1%
Lip pain
1%
Rash pruritic
1%
Acute kidney injury
1%
Arthralgia
1%
Urinary tract infection
1%
Staphylococcal bacteraemia
1%
Serratia infection
1%
Gastrointestinal disorders
1%
General disorders
1%
Skin disorders
1%
Chronic lymphocytic leukaemia
1%
Pulmonary embolism
1%
Vascular disorders
1%
Dyspnoea
1%
Rhinorrhoea
1%
Hallucination, visual
1%
Nightmare
1%
Liver function test abnormal
1%
Blood glucose abnormal
1%
Transaminases increased
1%
Acute coronary syndrome
1%
Supraventricular tachycardia
1%
Memory impairment
1%
Peripheral ischaemia
1%
Swelling face
1%
Extravasation
1%
Peripheral swelling
1%
Hiccups
1%
Pneumothorax
1%
Oedema peripheral
1%
Chest discomfort
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Brensocatib
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
43 Previous Clinical Trials
7,552 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
682 Patients Enrolled for Cystic Fibrosis