Hidradenitis Suppurativa
Conditions
Brief summary
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.
Interventions
DRUGOrismilast
Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties
Sponsors
UNION therapeutics
Gregor Jemec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adult patients, 18 years of age or older. 2. 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. 3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal). 4. Has a total inflammatory lesions (AN) count of greater than or equal to 2. 5. Total draining fistula count of less than or equal to 30. 6. A stable analgesic dose for 2 weeks prior to baseline.
Exclusion criteria
1. Presence of active skin lesions other than HS that could interfere with the assessment of HS. 2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2). 3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit. 4. Any oral antibiotic within 28 days prior to baseline visit. 5. Receipt of a live vaccine within 14 days prior to screening. 6. 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. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline in AN (abscesses and nodules) count at Week 16 | Day 1 to Week 16 | Total count of abscess and inflammatory nodules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in abscess, nodule, and draining fistula counts at Week 16 | Day 1 to Week 16 | Total count of abscess, inflammatory nodules, and draining fistula |
| Change from Baseline in IHS4 value at Week 16 | Day 1 to 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). |
| Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16 | Day 1 to 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). |
| Change from Baseline in HiSQOL Total Score at 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 |
Contacts
Primary ContactGregor Jemec, Professor
Outcome results
None listed