Viewing Study NCT05139602


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Study NCT ID: NCT05139602
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-08-14
First Post: 2021-11-29
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy
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': 'C000655035', 'term': 'lutikizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)', 'timeFrame': 'Week 16', 'description': 'HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Approximately Week 68', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3', 'timeFrame': 'Week 16', 'description': "NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa', 'Lutikizumab', 'ABT-981'], 'conditions': ['Hidradenitis Suppurativa']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M20-262', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy.\n\nLutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites.\n\nIn the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.\n* A total abscess and inflammatory nodule (AN) count of \\>= 5 at Baseline\n* HS lesions must be present in at least 2 distinct anatomic areas.\n* Must have failed anti-TNF treatment for HS.\n* To be eligible for the Sub-study, participants must be naïve to biologic therapy for treatment of HS.\n\nExclusion Criteria:\n\n\\- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.'}, 'identificationModule': {'nctId': 'NCT05139602', 'briefTitle': 'A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy: Amended Protocol to Include a Lutikizumab Open-Label Sub-study in Subjects Naïve to Biologic Therapy', 'orgStudyIdInfo': {'id': 'M20-262'}, 'secondaryIdInfos': [{'id': '2020-004108-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main Study: Lutikizumab Dose A', 'description': 'Lutikizumab Dose A every week', 'interventionNames': ['Biological: Lutikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Main Study: Lutikizumab Dose B', 'description': 'Lutikizumab Dose B every other week', 'interventionNames': ['Biological: Lutikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Main Study: Lutikizumab Dose C', 'description': 'Lutikizumab Dose C every other week', 'interventionNames': ['Biological: Lutikizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Main Study: Placebo', 'description': 'Placebo every week', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-study: Group 1', 'description': 'Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.', 'interventionNames': ['Biological: Lutikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-study: Group 2', 'description': 'Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.', 'interventionNames': ['Biological: Lutikizumab']}], 'interventions': [{'name': 'Lutikizumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-981'], 'description': 'Subcutaneous Injection', 'armGroupLabels': ['Main Study: Lutikizumab Dose A', 'Main Study: Lutikizumab Dose B', 'Main Study: Lutikizumab Dose C', 'Sub-study: Group 1', 'Sub-study: Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous Injection', 'armGroupLabels': ['Main Study: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Dermatology Specialists /ID# 240641', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259-5452', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Scottsdale /ID# 241030', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '71913-6404', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research /ID# 240811', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '93701-2302', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno /ID# 240903', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medderm Associates /ID# 240729', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91320-2130', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research Institute /ID# 240642', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '06416-1745', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CCD Research, PLLC /ID# 240728', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '33486-2269', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research Boca Raton /ID# 240758', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Apex Clinical Trials /ID# 248558', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'GSI Clinical Research, LLC /ID# 240901', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International Rsrch cr /ID# 240902', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Park Avenue Dermatology, PA /ID# 240807', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'TruDerm Dermatology of Wellington /ID# 240780', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin, LLC /ID# 240701', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215-5400', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center /ID# 240683', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48084-3536', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Revival Research Institute, LLC /ID# 241020', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'MediSearch Clinical Trials /ID# 240810', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 240797', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68144-1105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Advanced Dermatology of the Midlands /ID# 249750', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Duplicate_Skin Specialists, PC /ID# 240804', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07044-2946', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Schweiger Dermatology, P.C. /ID# 240900', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029-6504', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Doctors Dermatology /ID# 241588', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center /ID# 240853', 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241288', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Research /ID# 241096', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': 'T3A 2N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Beacon Dermatology Inc /ID# 240741', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Wiseman Dermatology Research /ID# 240738', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L8L 3C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'J7Z 7E2', 'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dre Angelique Gagne-Henley M.D. inc. /ID# 240739', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Duplicate_Universitaetsklinikum Erlangen /ID# 240872', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Hamburg-Eppendorf /ID# 240873', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '13595', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Havelklinik /ID# 240874', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Klinikum Ruhr Univ Bochum /ID# 240870', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '06847', 'city': 'Dessau', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Dessau /ID# 240871', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': '401 GSNA - 401 Army General Hospital /ID# 242189', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Duplicate_University General Hospital Attikon /ID# 240371', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '16121', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'General Hospital Andreas Syggros /ID# 241104', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '55536', 'city': 'Stavroupoli (Thessalonikis)', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385', 'geoPoint': {'lat': 40.66944, 'lon': 22.93806}}, {'zip': '54642', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki Hippokrateio /ID# 240697', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital /ID# 244392', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital /ID# 244390', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine /ID# 244739', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '903-0215', 'city': 'Nakagami-gun', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'University of the Ryukyus Hospital /ID# 244848'}, {'zip': '589-8511', 'city': 'Osakasayama-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kindai University Hospital /ID# 245358'}, {'zip': '00985', 'city': 'Carolina', 'state': 'Puerto Rico', 'country': 'Puerto Rico', 'facility': 'Alma M. Cruz Santana, MD-Private practice /ID# 244514', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau /ID# 240529', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves /ID# 240429', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon /ID# 240396', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46940', 'city': 'Manises', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Manises /ID# 240440', 'geoPoint': {'lat': 39.49139, 'lon': -0.46349}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}