Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 4:55 PM
Study NCT ID:
NCT04982432
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from Baseline in AN (abscesses and nodules) count at Week 16', 'timeFrame': 'Day 1 to Week 16', 'description': 'Total count of abscess and inflammatory nodules'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in abscess, nodule, and draining fistula counts at Week 16', 'timeFrame': 'Day 1 to Week 16', 'description': 'Total count of abscess, inflammatory nodules, and draining fistula'}, {'measure': 'Change from Baseline in IHS4 value at Week 16', 'timeFrame': 'Day 1 to Week 16', 'description': '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).'}, {'measure': "Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16", 'timeFrame': 'Day 1 to Week 16', 'description': "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)."}, {'measure': 'Change from Baseline in HiSQOL Total Score at Week 16', 'timeFrame': 'Change from Baseline in HiSQOL Total Score at Week 16', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult patients, 18 years of age or older.\n2. 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.\n3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).\n4. Has a total inflammatory lesions (AN) count of greater than or equal to 2.\n5. Total draining fistula count of less than or equal to 30.\n6. A stable analgesic dose for 2 weeks prior to baseline.\n\nExclusion Criteria:\n\n1. Presence of active skin lesions other than HS that could interfere with the assessment of HS.\n2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).\n3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.\n4. Any oral antibiotic within 28 days prior to baseline visit.\n5. Receipt of a live vaccine within 14 days prior to screening.\n6. 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.\n7. 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.'}, 'identificationModule': {'nctId': 'NCT04982432', 'acronym': 'OSIRIS', 'briefTitle': 'Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)', 'orgStudyIdInfo': {'id': 'OSIRIS [UNI50007-201]'}, 'secondaryIdInfos': [{'id': '2021-000049-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orismilast', 'description': 'Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.', 'interventionNames': ['Drug: Orismilast']}], 'interventions': [{'name': 'Orismilast', 'type': 'DRUG', 'otherNames': ['UNI5001'], 'description': 'Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties', 'armGroupLabels': ['Orismilast']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gregor Jemec, Professor', 'role': 'CONTACT', 'email': 'gbj@regionsjaelland.dk', 'phone': '+4547322601'}], 'overallOfficials': [{'name': 'Gregor Jemec, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zealand University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gregor Jemec', 'class': 'OTHER'}, 'collaborators': [{'name': 'UNION therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gregor Jemec', 'investigatorAffiliation': 'Zealand University Hospital'}}}}