Hidradenitis SuppurativaPhase 2CEDARNCT06685835
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
A Phase 2 study testing Brensocatib in people with Hidradenitis Suppurativa, run by Insmed Incorporated at 72 sites in 10 countries.
Trial summary
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Brensocatib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 72 sitesin 10 countries
- Study dates
- 16 Dec 2024to 8 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
- 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.
Who cannot join
- Draining tunnel count of ≥20 at the Baseline Visit.
- Surgical or laser intervention for an HS lesion during the Screening Period.
- Clinical diagnosis of Papillon-Lefèvre Syndrome.
- Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
- Participants having active liver disease or hepatic dysfunction.
- Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
Show all 15Show fewer
- Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeks before the Baseline Visit
- Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.
- Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
- Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
- Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
- 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.
- Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
- Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
- Note: Other Inclusion/Exclusion criteria may apply.
Trial locations and contacts
72 sites in 10 countries.
72 sites in 10 countries
United States26 sites
USA028
Atlanta, Georgia, 30329
USA002
Baton Rouge, Louisiana, 70809-2725
USA017
Boston, Massachusetts, 02115
USA009
Cleveland, Ohio, 44106-1716
USA026
Coral Gables, Florida, 33134
USA005
Dallas, Texas, 75230
USA023
Dallas, Texas, 75231-6077
USA012
Detroit, Michigan, 48201
USA024
Fort Gratiot, Michigan, 48059
USA019
Hershey, Pennsylvania, 17033-2360
USA027
Hollywood, Florida, 33024
USA013
Lebanon, New Hampshire, 03766
USA021
Margate, Florida, 33063
USA018
Miami, Florida, 33125
USA020
Minneapolis, Minnesota, 55455
USA025
Ocala, Florida, 34470
USA022
Philadelphia, Pennsylvania, 19104-5127
USA001
Phoenix, Arizona, 85054-4502
USA003
Plainfield, Indiana, 46168
USA007
Sacramento, California, 95815
USA011
Sandy Springs, Georgia, 30328
USA008
Spokane, Washington, 99202
USA016
Springfield, Ohio, 45505
USA015
St Louis, Missouri, 63104
USA004
Tampa, Florida, 33613
USA010
Weston, Florida, 33331
Poland8 sites
POL004
Krakow, 30-727
POL002
Rzeszów, Podkarpackie Voivodeship, 35-055
POL008
Warsaw, Masovian Voivodeship, 02-507
POL007
Warsaw, 02-793
POL001
Warsaw, 02-962
POL006
Wroclaw, Lower Silesian Voivodeship, 51-685
POL005
Wroclaw, 50-450
POL003
Wroclaw, 50-566
Canada7 sites
CAN003
Barrie, Ontario, L4M 7G1
CAN006
Guelph, Ontario, N1L 0B7
CAN007
Peterborough, Ontario, K9J 5K2
CAN004
Québec, G1W 4R4
CAN011
Richmond Hill, Ontario, L4B 1A5
CAN009
Richmond Hill, Ontario, L4C 9M7
CAN010
Toronto, Ontario, M2N 3A6
Germany6 sites
DEU001
Bochum, North Rhine-Westphalia, 44791
DEU002
Darmstadt, Hesse, 64283
DEU006
Dessau-Roßlau, 6847
DEU003
Dresden, Saxony, 1307
DEU007
Langenau, Baden-Wurttemberg, 89129
DEU005
Lübeck, 23538
Spain6 sites
ESP006
Badalona, Barcelona, 08916
ESP004
Las Palmas de Gran Canaria, Las Palmas Provincia, 35010
ESP002
Madrid, 28007
ESP005
Madrid, 28026
ESP003
Madrid, 28034
ESP001
Manises, Valencia, 46940
Australia5 sites
AUS001
Brisbane, Queensland, 4151
AUS003
Darlinghurst, New South Wales, 2010
AUS002
Fremantle, Western Australia, 6160
AUS004
Kogarah, New South Wales, 2217
AUS006
Woolloongabba, Queensland, 4102
France5 sites
FRA002
Antony, 92160
FRA001
Lyon, Auvergne-Rhône-Alpes, 69003
FRA003
Paris, 75010
FRA005
Rouen, 76031
FRA004
Toulouse, Haute-Garonne, 31000
Bulgaria4 sites
BGR001
Lovech, 5500
BGR003
Pleven, 5800
BGR004
Sofia, 1592
BGR002
Stara Zagora, 6003
Greece4 sites
GRC002
Athens, Attica, 106 79
GRC004
Chaïdári, Attica, 124 62
GRC001
N. Efkapria-Pavlos Melas, Thessaloniki, 56403
GRC003
Thessaloniki, 54643
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Brensocatib, Placebo
- Keywords
- HS
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrensocatibDrug
Also called INS1007
Film-coated Oral tablet
PlaceboDrug
Film-coated Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Brensocatib 10 mg | Experimental | Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks. Receives: Drug: Brensocatib |
| Brensocatib 40 mg | Experimental | Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks. Receives: Drug: Brensocatib |
| Placebo Followed by Brensocatib 10 mg | Placebo comparator | Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks. Receives: Drug: Brensocatib; Drug: Placebo |
| Placebo Followed by Brensocatib 40 mg | Placebo comparator | Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks. Receives: Drug: Brensocatib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
Measured: Baseline and Week 16
Secondary outcomes (11)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Measured: Week 16
Percentage of Participants Achieving HiSCR75 at Week 16
Measured: Week 16
Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16
Measured: Week 16
Change From Baseline in Draining Tunnel Count at Week 16
Measured: Baseline and Week 16
Percentage of Participants Remaining Free from HS Flare by Week 16
Measured: Week 16
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
Measured: Baseline and Week 16
Percentage of Participants Achieving IHS4-55 at Week 16
Measured: Week 16
Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16
Measured: Baseline and Week 16
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3
Measured: Week 16
Number of Participants who Experienced at Least One Adverse Event (AE)
Measured: Up to Week 56
Plasma Concentration of Brensocatib
Measured: Pre-dose and at multiple timepoints post-dose up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start16 Dec 2024
- Primary completion12 Feb 2026
- Study completion8 Jun 2026
Why it stopped: Lack of Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685835
- Sponsor's protocol ID
- INS1007-231
- Other IDs
- 2024-515959-38-00
- Acronym
- CEDAR
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study
- ClinicalTrials.gov ID
- NCT06685835
- Acronym / sponsor ID
- CEDAR / INS1007-231
- Conditions
- Hidradenitis Suppurativa
- Keywords
- HS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Efficacy
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brensocatib 10 mg | Experimental | Drug: BrensocatibParticipants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks. |
| Brensocatib 40 mg | Experimental | Drug: BrensocatibParticipants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks. |
| Placebo Followed by Brensocatib 10 mg | Placebo comparator | Drug: Brensocatib, Drug: PlaceboParticipants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks. |
| Placebo Followed by Brensocatib 40 mg | Placebo comparator | Drug: Brensocatib, Drug: PlaceboParticipants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
- 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.
Key exclusion criteria (15 listed)
- Draining tunnel count of ≥20 at the Baseline Visit.
- Surgical or laser intervention for an HS lesion during the Screening Period.
- Clinical diagnosis of Papillon-Lefèvre Syndrome.
- Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
- Participants having active liver disease or hepatic dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrensocatibAlso: INS1007Film-coated Oral tablet | Drug | Brensocatib 10 mg, Brensocatib 40 mg, Placebo Followed by Brensocatib 10 mg, Placebo Followed by Brensocatib 40 mg |
| PlaceboFilm-coated Oral tablet | Drug | Placebo Followed by Brensocatib 10 mg, Placebo Followed by Brensocatib 40 mg |
Primary outcome
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
Time frame: Baseline and Week 16
11 secondary outcomes
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Time frame: Week 16
Percentage of Participants Achieving HiSCR75 at Week 16
Time frame: Week 16
Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16
Time frame: Week 16
Change From Baseline in Draining Tunnel Count at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Remaining Free from HS Flare by Week 16
Time frame: Week 16
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Achieving IHS4-55 at Week 16
Time frame: Week 16
Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3
Time frame: Week 16
Number of Participants who Experienced at Least One Adverse Event (AE)
Time frame: Up to Week 56
Plasma Concentration of Brensocatib
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 56
Results and safety
The study was stopped early (reason given: Lack of Efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Insmed Incorporated
72 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brensocatib in people with Hidradenitis Suppurativa, run by Insmed Incorporated at 72 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Poland, Canada, Germany, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.