Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.

Official Title
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Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Orismilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adult patients, 18 years of age or older. Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal). Has a total inflammatory lesions (AN) count of greater than or equal to 2. Total draining fistula count of less than or equal to 30. A stable analgesic dose for 2 weeks prior to baseline. Exclusion Criteria: Presence of active skin lesions other than HS that could interfere with the assessment of HS. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2). Receipt of systemic therapies for HS, within 28 days prior to the baseline visit. Any oral antibiotic within 28 days prior to baseline visit. Receipt of a live vaccine within 14 days prior to screening. Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orismilast<br>Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment. | Drug: Orismilast<br>* Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties<br>* Other names: UNI5001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from Baseline in AN (abscesses and nodules) count at Week 16 | Total count of abscess and inflammatory nodules | Day 1 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in abscess, nodule, and draining fistula counts at Week 16 | Total count of abscess, inflammatory nodules, and draining fistula | Day 1 to Week 16 | 
| Change from Baseline in IHS4 value at Week 16 | ISH4 is a validated international clinimetric scale. The score is based on a count of inflamed lesions. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). | Day 1 to Week 16 | 
| Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16 | Completion of questionnaire covering skin pain Patient's Global Assessment of Skin Pain (0=no pain, 10=worst imaginable pain) 0-10 Numerical Rating Scale (NRS). | Day 1 to Week 16 | 
| Change from Baseline in HiSQOL Total Score at Week 16 | Patient completion of the Hidradenitis Suppurativa Quality of Life (HiSQOL) questionnaire that contains Hidradenitis Suppurativa specific items such as drainage and odor in addition to more general skin specific items | Change from Baseline in HiSQOL Total Score at Week 16 |