← Back to Search

Anti-inflammatory

Brensocatib for Hidradenitis Suppurativa (CEDAR Trial)

Phase 2
Recruiting
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit
HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits
Must not have
Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit
Clinical diagnosis of Papillon-Lefèvre Syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

"This trial aims to see if brensocatib has a different effect compared to a placebo."

Who is the study for?
This trial is for adults with moderate to severe Hidradenitis Suppurativa (HS), a skin condition. Participants must have been diagnosed by a dermatologist, had HS for at least 6 months, and have at least 6 inflammatory lesions in two different areas of the body.
What is being tested?
The study is testing the effectiveness and safety of Brensocatib compared to a placebo in treating HS. Patients will be randomly assigned to receive either Brensocatib or an inactive substance without knowing which one they are getting.
What are the potential side effects?
While specific side effects of Brensocatib are not listed here, common side effects may include reactions at the medication application site, gastrointestinal issues, headaches, or potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had 6 or more painful skin bumps for at least 8 weeks.
Select...
I have HS lesions in 2 different areas, with at least one being moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any anti-TNF or similar biologic treatments recently.
Select...
I have been diagnosed with Papillon-Lefèvre Syndrome.
Select...
I have active liver disease or a liver condition.
Select...
I haven't taken any antibiotics in the last 8 weeks, except for stable doses of Doxycycline or Minocycline.
Select...
I have not taken any immune-modifying drugs in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 3 trial • 406 Patients • NCT04817332
14%
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%
Tachyarrhythmia
1%
Glossodynia
1%
Fall
1%
Mouth ulceration
1%
Hypokalaemia
1%
Clostridium difficile colitis
1%
Pneumonia
1%
Dry mouth
1%
Palpitations
1%
Candida infection
1%
Sinus bradycardia
1%
Swollen tongue
1%
Pruritus
1%
Subcutaneous emphysema
1%
Hepatic function abnormal
1%
Constipation
1%
Bradycardia
1%
Headache
1%
Vomiting
1%
Gastritis erosive
1%
Dry skin
1%
Muscle spasms
1%
Gingival bleeding
1%
Gastrooesophageal reflux disease
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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Brensocatib 40 mgExperimental Treatment1 Intervention
Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.
Group II: Brensocatib 10 mgExperimental Treatment1 Intervention
Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.
Group III: Placebo Followed by Brensocatib 10 mgPlacebo Group2 Interventions
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.
Group IV: Placebo Followed by Brensocatib 40 mgPlacebo Group2 Interventions
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.
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
7,377 Total Patients Enrolled
~136 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top