Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT03049267
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2016-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505730', 'term': 'apremilast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.', 'timeFrame': 't=16 weeks', 'description': 'measurement by qPCR'}, {'measure': 'Change of expression levels of inflammatory cytokine protein in HS lesional skin.', 'timeFrame': 't=16 weeks', 'description': 'measurement by ELISA'}], 'secondaryOutcomes': [{'measure': 'Abscesses count', 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'Total number of abscesses \\[A\\]'}, {'measure': 'Nodule count', 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'Total number of inflammatory \\[N\\] and non-inflammatory nodules'}, {'measure': 'Fistula count', 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'Total count of draining fistulas'}, {'measure': "Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score", 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'Based on the HS lesion count'}, {'measure': 'Hidradenitis Suppurativa Clinical Response (HiSCR)', 'timeFrame': 't=0 weeks, t=16 weeks', 'description': 'Based on the AN count; The proposed definition of 50% and 30% responders to treatment (HiSCR achievers) is respectively: (i) at least a 50% and 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline.'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'To assess the patient reported outcome measures (PROMs) pain, pruritus and patient disease global assessment score;'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 't=0 weeks, t=4 weeks, t=16 weeks', 'description': 'To assess the patient reported outcome measures (PROM) quality of life'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Multiple time points between t=0 weeks and t=16 weeks', 'description': 'Vital signs: heart rate, temperature, blood pressure. Patient reported adverse events Safety laboratories: White blood cell count, Absolute neutrophil count, Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne inversa'], 'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'Study design: A double-blind randomised placebo-controlled trial\n\nIntervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.\n\nPrimary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):\n\n* of patients receiving apremilast compared to placebo;\n* within both groups relative to baseline (t=0).\n\nSecondary objectives:\n\n* To prospectively evaluate the clinical efficacy of apremilast.\n* To assess the effect of apremilast on patient reported outcomes measures.\n* To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.', 'detailedDescription': 'Rationale:\n\nHidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.\n\nSystemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion criteria:\n\n* Adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);\n* HS of more than 6 months duration; have lesions in at least two anatomical locations.\n\nKey exclusion criteria:\n\n* Contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS;\n* Presence of other uncontrolled major disease;\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT03049267', 'acronym': 'SMASH', 'briefTitle': 'Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'SMASH trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apremilast', 'description': 'N=15', 'interventionNames': ['Drug: Apremilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'N=5', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Apremilast', 'type': 'DRUG', 'otherNames': ['Otezla, CC-10004'], 'description': 'Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.', 'armGroupLabels': ['Apremilast']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo comparator'], 'description': 'Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.', 'armGroupLabels': ['Placebo Oral Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Errol Prens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.B.A. van Doorn', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'M.B.A. van Doorn', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}