Brensocatib for Hidradenitis Suppurativa

(CEDAR Trial)

Not currently recruiting at 85 trial locations

Overseen By Insmed Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Insmed Incorporated

Must be taking: Doxycycline, Minocycline

Must not be taking: Opioids, Biologics, Corticosteroids, others

Disqualifiers: Liver disease, Periodontal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called brensocatib to evaluate its effectiveness for people with hidradenitis suppurativa (HS), a skin condition that causes painful lumps and abscesses. The study compares different doses of brensocatib with a placebo (a pill with no active drug) to assess its effectiveness. Participants should have moderate to severe HS with symptoms lasting at least six months and at least six inflamed lumps. Those who have tried other treatments recently or have certain health conditions may not qualify for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before participating. For example, you must stop taking systemic antibiotics, opioid painkillers (except tramadol), and certain topical treatments for HS before the trial. However, if you're on doxycycline or minocycline and have been stable for at least 8 weeks, you can continue those.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that brensocatib was safe in earlier studies. In the ASPEN study, brensocatib reduced lung issues in people with bronchiectasis, a lung condition, and the study also assessed its safety. The results indicated that most patients tolerated brensocatib well.

Although this research did not specifically target hidradenitis suppurativa (a skin condition with painful lumps), these findings suggest it is safe for humans. Since this trial is in Phase 2, brensocatib has already passed initial safety tests and is now under further study to assess its tolerability and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Researchers are excited about brensocatib for treating hidradenitis suppurativa because it offers a novel approach compared to standard treatments like antibiotics or biologics. Unlike these treatments, which often target inflammation or bacterial infection, brensocatib works by inhibiting an enzyme called DPP1, which is involved in the activation of neutrophil serine proteases, potentially reducing tissue damage and inflammation. This unique mechanism could lead to more effective management of symptoms with fewer side effects. Additionally, the option to adjust the dosage between 10 mg and 40 mg allows for personalized treatment, potentially enhancing efficacy and tolerability.

What evidence suggests that brensocatib might be an effective treatment for hidradenitis suppurativa?

This trial will evaluate the effectiveness of brensocatib for hidradenitis suppurativa (HS). Studies have shown that brensocatib effectively reduces inflammation by blocking a substance in the body that causes long-term inflammation. Although most research has focused on lung issues like bronchiectasis, these findings suggest it might also help with other inflammatory conditions, such as HS. In earlier studies, brensocatib significantly slowed the decline in lung function and reduced flare-ups of lung disease symptoms. This offers hope that it could also lessen the painful skin inflammation seen in HS. Initial results are promising, but more research is needed to confirm its benefits specifically for HS. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with HS by a dermatologist and have had it for at least 6 months.

I have had 6 or more painful skin bumps for at least 8 weeks.

I have HS lesions in 2 different areas, with at least one being moderate to severe.

Exclusion Criteria

I haven't taken any anti-TNF or similar biologic treatments recently.

I have taken medication like steroids for my condition in the last 4 weeks.

Draining tunnel count of ≥20 at the Baseline Visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brensocatib or placebo for a total of 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brensocatib

Trial Overview 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.

How Is the Trial Designed?

Group I: Brensocatib 40 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.

Group II: Brensocatib 10 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.

Group III: Placebo Followed by Brensocatib 10 mg Placebo Group 2 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 mg Placebo Group 2 Interventions

Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials

44

Recruited

7,600+

Published Research Related to This Trial

A systematic review of 5310 articles led to the analysis of 171 studies, resulting in evidence-based recommendations for managing hidradenitis suppurativa (HS), emphasizing the use of topical clindamycin for mild cases and biologic therapy like adalimumab for more severe cases after conventional treatments fail.

The review established that local surgical excision is recommended for mild-to-moderate HS, while more extensive disease may require wide excision, highlighting the need for tailored treatment approaches based on disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. Zouboulis, CC., Bechara, FG., Dickinson-Blok, JL., et al.[2020]

This systematic review highlights new therapeutic targets for hidradenitis suppurativa (HS), focusing on cytokines like IL-1, IL-23, and IL-17, as well as Jak inhibition, based on observational data and ongoing placebo-controlled studies.

There are concerns about high placebo response rates and the reliability of clinical scoring in some studies, indicating a need for more detailed inflammatory profiling to better understand HS and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Promising Therapeutic Targets in Hidradenitis Suppurativa: A Critical Evaluation of Mechanistic and Clinical Relevance. Frew, JW., Marzano, AV., Wolk, K., et al.[2021]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

In a clinical trial involving 15 patients with moderate to severe hidradenitis suppurativa, RGRN-305 demonstrated significant efficacy, with 60% of patients achieving a 50% improvement in symptoms (HiSCR-50) compared to only 20% in the placebo group.

RGRN-305 was well tolerated, showing no serious adverse events, and also led to improvements in secondary outcomes, indicating its potential as a novel treatment option for this painful condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa: A Parallel-Design Double-Blind Trial. Ben Abdallah, H., Bregnhøj, A., Emmanuel, T., et al.[2023]

Adalimumab and infliximab are the most studied treatments for moderate to severe hidradenitis suppurativa (HS), with clinical trials showing their efficacy, while other agents like anakinra and ustekinumab also demonstrate promise.

Adalimumab is currently the only biologic approved by the FDA for HS, and most treatments have a good safety profile, although infections are the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. Lim, SYD., Oon, HH.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06685835

NCT06685835 | A Study of the Efficacy and Safety ... A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS) (CEDAR). ClinicalTrials.gov ID NCT06685835.

2. investor.insmed.com investor.insmed.com/2025-04-23-New-England-Journal-of-Medicine-Publishes-Positive-Results-from-Insmeds-Pivotal-Phase-3-ASPEN-Study-of-Brensocatib-in-Patients-with-Bronchiectasis

New England Journal of Medicine Publishes Positive ... Brensocatib 25 mg is the first investigational therapy for bronchiectasis to show a statistically significant reduction in the rate of lung function decline.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20584495

Study of the Efficacy and Safety of Brensocatib in Adults ... Clinical Trials · Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa · More about research at Mayo Clinic.

4. prnewswire.com prnewswire.com/news-releases/brensocatib-shows-consistent-efficacy-and-safety-across-three-prespecified-subgroups-in-new-data-from-landmark-aspen-study-302462008.html

Brensocatib Shows Consistent Efficacy and Safety Across ... Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung ...

5. withpower.com withpower.com/trial/brensocatib-for-hidradenitis-suppurativa-3f6ee

Brensocatib for Hidradenitis Suppurativa (CEDAR Trial) Trial Overview The study is testing the effectiveness and safety of Brensocatib compared to a placebo in treating HS. Patients will be randomly assigned to ...

6. investor.insmed.com investor.insmed.com/2024-05-28-Insmed-Announces-Positive-Topline-Results-from-Landmark-ASPEN-Study-of-Brensocatib-in-Patients-with-Bronchiectasis

Press Releases The ASPEN study has demonstrated a statistically significant and clinically meaningful treatment effect for brensocatib compared with placebo.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06685835?term=AREA%5BConditionSearch%5D(Hidradenitis%20Suppurativa)%20AND%20SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DAustralia%20AND%20AREA%5BLocationState%5DQueensland)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=1

A Study of the Efficacy and Safety of Brensocatib in Adults ... Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...