Efficacy and Safety Evaluation of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa: A Randomized, Double-Blind, Placebo-Controlled Study
- Trial ID
- 2024-515959-38-00
- Protocol
- INS1007-231
- Sponsor
- Insmed Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the effect of **brensocatib** compared with placebo in adults with moderate to severe **Hidradenitis Suppurativa**. This is clinically relevant as it aims to determine the efficacy of brensocatib in reducing the symptoms and progression of this chronic inflammatory skin condition, which can significantly impact patients' quality of life.
Secondary objectives include:
- Period 1 (Double-Blind Placebo-Controlled): To evaluate the effect of brensocatib compared with placebo; to assess the safety and tolerability of brensocatib; and to evaluate the systemic exposure of brensocatib.
- Period 2 (Double-Blind Active Treatment): To assess the long-term safety and tolerability of brensocatib and to evaluate the systemic exposure of brensocatib.
Participants
The clinical trial involves a total of **88 participants** diagnosed with **Hidradenitis Suppurativa**. The study population comprises adult male and female participants aged between 18 and 80 years. Participants were selected based on a confirmed diagnosis of moderate to severe Hidradenitis Suppurativa, with a history of symptoms for at least six months prior to the screening. The trial includes individuals with at least six inflammatory lesions present for a minimum of eight weeks before the baseline visit, and lesions must be located in at least two distinct anatomical areas, with one area classified as Hurley Stage II or III. Both male and female participants are required to adhere to contraceptive guidelines consistent with local regulations. The trial population includes a vulnerable group, ensuring comprehensive representation of the affected demographic. Participants' general health status is not specified beyond the inclusion criteria related to the disease. Lifestyle factors such as diet and physical activity are not detailed in the available data.
Plans and Procedures
The clinical trial is a **randomized, double-blind, placebo-controlled** study designed to evaluate the efficacy and safety of **brensocatib** in adults with moderate to severe **hidradenitis suppurativa**. The trial is set to commence recruitment on March 1, 2025, and is expected to conclude by March 1, 2027. Participants will be randomly assigned to receive either brensocatib or a placebo, both administered as film-coated tablets, ensuring blinding and control within the study. The trial will span a maximum treatment period of 52 weeks, with a daily dose of brensocatib not exceeding 10 mg.
The study will involve several key visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, disease characteristics, and contraceptive requirements. Participants must be adults aged 18 to 80 with a confirmed diagnosis of hidradenitis suppurativa, exhibiting at least six inflammatory lesions for a minimum of eight weeks prior to the baseline visit. The baseline visit will establish initial measurements and conditions for each participant. Follow-up visits will occur at regular intervals to monitor progress and assess the primary endpoint, which is the percent change from baseline in total abscess and inflammatory nodule count at Week 16. Secondary endpoints include responder status for achieving HiSCR50 and HiSCR75 at Week 16.
The expected length of participant involvement is approximately 52 weeks, with conditions for early termination including non-compliance with study protocols or adverse events that compromise participant safety. The end-of-study visit will finalize data collection and ensure participant well-being post-trial. This structured approach ensures rigorous assessment of brensocatib's therapeutic potential in treating hidradenitis suppurativa while maintaining participant safety and data integrity throughout the trial duration.
Treatment
The clinical trial involves the administration of **Brensocatib**, an experimental medication, in the form of a **film-coated tablet**. The active substance, Brensocatib, is chemically derived and is identified by the sponsor product code **INS1007**. The pharmaceutical form is a film-coated tablet, and the medication is administered orally. The maximum daily dose is 10 mg, with a total maximum dose of 3640 mg over a treatment period of 52 weeks. The trial aims to evaluate the efficacy and safety of Brensocatib in adults with moderate to severe **Hidradenitis Suppurativa**. Participant compliance with the dosing schedule is monitored throughout the study.
The study also includes a placebo group. The placebo is formulated using the same excipients as the investigational medicinal product (IMP) but without the active drug substance. It is developed as a film-coated tablet, identical in size and appearance to the IMP, to maintain the double-blind nature of the trial. The placebo is administered orally, following the same dosing schedule as the active treatment group, to ensure consistency in administration and compliance monitoring.
Efficacy
The efficacy of **Brensocatib** in the treatment of moderate to severe Hidradenitis Suppurativa will be assessed in a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study. The primary endpoint for evaluating efficacy is the percent change from baseline in the total abscess and inflammatory nodule count (AN count) at Week 16. Secondary endpoints include the responder status for achieving HiSCR50 and HiSCR75 at Week 16. These endpoints will be analyzed in a manner consistent with the primary endpoint. The study will involve the administration of Brensocatib in the form of film-coated tablets, with a maximum daily dose of 10 mg and a maximum treatment period of 52 weeks. The placebo used in the study will be identical in size and appearance to the investigational medicinal product (IMP) but will not contain the active drug substance. The efficacy assessments will be conducted at specified timepoints, with the primary analysis occurring at Week 16. The study aims to provide a comprehensive evaluation of the efficacy of Brensocatib compared to placebo in the target population.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Age 1. Adult male or female participants ≥18 to ≤80 years of age at the time of signing the informed consent.
- Type of Participant and Disease Characteristics 2. Participants have a 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. 3. Participants have moderate or severe HS defined as a total of ≥6 inflammatory (inflammatory nodules and/or abscesses) lesions for at least 8 weeks before the Baseline Visit. 4. Participants have 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.
- Sex and Contraceptive/Barrier Requirements 5. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male Participants: From Day 1 to at least 90 days after the last dose of study drug, male participants, who are not sterile, should refrain from donating fresh unwashed sperm and must be using effective contraception with female partners of childbearing potential. Male participants with pregnant or non-pregnant WOCBP partners must agree to use a male condom and should also be advised of the benefit for female partners to use an additional highly effective contraceptive method as defined in Section 10.4.2. b. Female Participants: Women must be postmenopausal, surgically sterile, or using highly effective contraception methods (as defined in Section 10.4.2) from Day 1 to at least 90 days after the last dose of study drug. The Investigator or designee should explain the acceptable methods of birth control to the participant and instruct the participant to follow the direction.
- Informed Consent 6. Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria
- Medical Conditions 1. Draining tunnel count of ≥20 at the Baseline Visit. 2. Other active skin disease or condition that could interfere with HS assessments 3. Surgical or laser intervention for an HS lesion during the Screening Period. 4. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator. 5. Known history of HIV infection. 6. Established diagnosis of hepatitis B viral infection at the time of Screening, or positive for HBsAg at the time of Screening. a. Participants who have gained immunity for hepatitis B virus infection after vaccination b. Participants with positive HBcAb are eligible for the study only if hepatitis B virus DNA level is undetectable. 7. Established diagnosis of HCV infection at the time of Screening. Participants positive for hepatitis C antibody are eligible only if HCV RNA is negative. 8. History of malignancy in the past 5 years, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin. 9. Have diagnosed periodontal disease and are either: a. Under active management by a dentist for this condition or b. Expected to have periodontal disease-related procedures within the study period. 10. Clinical diagnosis of Papillon-Lefèvre Syndrome. 11. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participants participation in the study. 12. History of drug or alcohol abuse within 6 months before the Screening Visit.
- Prior/Concomitant Therapy 13. Received systemic (IV or PO) antibiotic therapy within 8 weeks before the Baseline Visit. a. PO doxycycline or minocycline up to 100 mg PO BID is permitted provided the dosing regimen has been stable for at least 8 weeks before the Baseline Visit and is expected to continue 14. Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit. 15. Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit. 16. Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit. 17. Received any anti-TNF-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit. 18. Received systemic nonbiologic therapies with potential therapeutic impact for HS within 4 weeks before the Baseline Visit. 19. Received any immunomodulatory agents within 4 weeks before the Baseline Visit. 20. Received any live attenuated vaccine within 4 weeks before the Screening Visit and during the Screening Period.If a live vaccine has been administered, the participant should wait 4 weeks before Screening.
- Prior/Concurrent Clinical Study Experience 21. Previously participated in a clinical study for brensocatib. 22. Participated in any other interventional clinical studies with an investigational medicinal product within 3 months or 5 half-lives, whichever is longer, before the Screening Visit. 23. Known history of hypersensitivity to brensocatib or any of its excipients. 24. Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. Diagnostic Assessments For the complete list and details of the principal exclusion criteria, please refer to section 5.2 in the Protocol v1.0 dd 12Jul2024
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Not Recruiting | 01 Mar 2025 | 13 |
 France | Not Recruiting | 01 Mar 2025 | 14 |
 Germany | Not Recruiting | 01 Mar 2025 | 29 |
 Greece | Not Recruiting | 01 Mar 2025 | 14 |
 The Netherlands | Not Recruiting | 01 Mar 2025 | — |
 Poland | Not Recruiting | 01 Mar 2025 | 27 |
 Spain | Not Recruiting | 01 Mar 2025 | 15 |
| Netherlands | — | — | 4 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
The placebo used the same excipients as that used in IMP without active drug substance. The placebo was developed as film-coated tablet same in size and appearance to the IMP. | Placebo | N/A | — | — | — | N/A |
BRENSOCATIB | Test | FILM-COATED TABLET | ORAL | 10 | 52 | PRD8212986 |
BRENSOCATIB | Test | FILM-COATED TABLET | ORAL USE | 10 | 52 | PRD5127666 |