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Trial record 1 of 4 for:    Orismilast
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Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)

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ClinicalTrials.gov Identifier: NCT04982432
Recruitment Status : Not yet recruiting
First Posted : July 29, 2021
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
UNION therapeutics
Information provided by (Responsible Party):
Gregor Jemec, Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Orismilast Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Orismilast
Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.
Drug: Orismilast
Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties
Other Name: UNI5001




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline in abscess, nodule, and draining fistula counts at Week 16 [ Time Frame: Day 1 to Week 16 ]
    Total count of abscess, inflammatory nodules, and draining fistula

  2. Change from Baseline in IHS4 value at Week 16 [ Time Frame: 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).

  3. Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16 [ Time Frame: 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).

  4. Change from Baseline in HiSQOL Total Score at Week 16 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982432


Contacts
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Contact: Gregor Jemec, Professor +4547322601 gbj@regionsjaelland.dk

Sponsors and Collaborators
Gregor Jemec
UNION therapeutics
Investigators
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Principal Investigator: Gregor Jemec, Professor Zealand University Hospital
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Responsible Party: Gregor Jemec, Professor, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04982432    
Other Study ID Numbers: OSIRIS [UNI50007-201]
2021-000049-42 ( EudraCT Number )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration