NCT04982432
Unknown
Phase 2
Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
Gregor Jemec0 sites24 target enrollmentOctober 1, 2021
Overview
- Phase
- Phase 2
- Intervention
- Orismilast
- Conditions
- Hidradenitis Suppurativa
- Sponsor
- Gregor Jemec
- Enrollment
- 24
- Primary Endpoint
- Percent change from Baseline in AN (abscesses and nodules) count at Week 16
- Last Updated
- 4 years ago
Overview
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.
Investigators
Gregor Jemec
Professor
Zealand University Hospital
Eligibility Criteria
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
- •Total draining fistula count of less than or equal to
- •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.
Arms & Interventions
Orismilast
Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.
Intervention: Orismilast
Outcomes
Primary Outcomes
Percent change from Baseline in AN (abscesses and nodules) count at Week 16
Time Frame: Day 1 to Week 16
Total count of abscess and inflammatory nodules
Secondary Outcomes
- Change from Baseline in abscess, nodule, and draining fistula counts at Week 16(Day 1 to Week 16)
- Change from Baseline in IHS4 value at Week 16(Day 1 to Week 16)
- Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16(Day 1 to Week 16)
- Change from Baseline in HiSQOL Total Score at Week 16(Change from Baseline in HiSQOL Total Score at Week 16)
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