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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000049-42 | EudraCT Number |
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| Name | Class |
|---|---|
| UNION therapeutics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orismilast | Experimental | Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orismilast | Drug | Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregor Jemec, Professor | Contact | +4547322601 | gbj@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gregor Jemec, Professor | Zealand University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
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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 |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |