Brensocatib for Hidradenitis Suppurativa

(CEDAR Trial)

Recruiting at 58 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

204 Participants Needed

Trial Summary

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.

What safety data exists for Brensocatib (AZD7986, INS1007) in humans?

The provided research articles do not contain specific safety data for Brensocatib (AZD7986, INS1007) in humans. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Promising Therapeutic Targets in Hidradenitis Suppurativa: A Critical Evaluation of Mechanistic and Clinical Relevance. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]

5. United States 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. [2023]