Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 9:14 AM
Study NCT ID:
NCT06319794
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1', 'timeFrame': 'Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)', 'description': 'Improvement from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale where 0 is complete clearance and 4 is no improvement)'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms)', 'timeFrame': 'Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)', 'description': 'Proportion of participants with partial (75% reduction in lesions) or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arm)'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'From first application of bimiralisib until 28 days after the last application', 'description': 'Safety endpoint assessed by treatment-emergent adverse events (including laboratory adverse events and vital signs)'}, {'measure': 'Incidence of local skin reactions', 'timeFrame': 'From first application of bimiralisib until 28 days after the last application', 'description': 'Tolerability endpoint assessed by Investigator for specific local skin reactions using 4-point clinical scales for irritation, stinging/burning and pruritus.\n\nScales from 0 (no signs) to 3 (severe)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands', 'detailedDescription': 'This is a multi-center, randomized, open label, parallel group study. The study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment.\n\nThe study consists of the following periods:\n\n* Screening (up to 30 days)\n* Treatment (2 or 4 weeks)\n* Follow-Up (4 weeks)\n\nParticipants will be randomized to one of two groups (1:1):\n\n* Arm A: Topical bimiralisib gel treatment for 2 weeks\n* Arm B: Topical bimiralisib gel treatment for 4 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must be of at least 50 years of age, at the time of signing the informed consent.\n* Have a clinical diagnosis of stable, clinically typical actinic keratosis.\n* Have at least 3 actinic keratosis lesions contained within contiguous treatment regions of face and/or scalp and/or back of hands.\n* Must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.\n* Must be willing to comply with sun avoidance measures for all exposed areas including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.\n* Must be in good general health (ECOG 0-1)\n* Participants of reproductive potential must agree to use double effective contraception from screening until 90 days after discontinuing study treatment.\n* Female participants who had a menstrual cycle within 2 years prior to screening must have a negative serum pregnancy test at screening and a negative urine pregnancy test on their first treatment day.\n* Must be capable of giving signed informed consent\n\nKey Exclusion Criteria:\n\n* Known or suspected hypersensitivity to any of the excipients of bimiralisib gel.\n* Clinically atypical and/or rapidly changing actinic keratosis lesions in the treatment area.\n* Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.\n* Participation in any clinical research study within 30 days of the Baseline Visit.\n* Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy, cryotherapy) within 4 weeks of the Baseline visit and within 2 cm of the selected treatment area.\n* Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to the Baseline Visit or planned use during the study.\n* Use of any retinoids within 90 days of the Baseline Visit, or glucocorticosteroids, methotrexate or other anti-metabolites or nicotinamide within 28 days of the Baseline Visit.\n* Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.\n* Any other malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not in the treatment area that were treated with curative intent and are without recurrence.\n* Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation'}, 'identificationModule': {'nctId': 'NCT06319794', 'briefTitle': 'Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TORQUR'}, 'officialTitle': 'A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period', 'orgStudyIdInfo': {'id': 'TQR-BTOP-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimiralisib - 2 weeks treatment', 'description': 'Topical bimiralisib for 2 weeks', 'interventionNames': ['Drug: Bimiralisib']}, {'type': 'EXPERIMENTAL', 'label': 'Bimiralisib - 4 weeks treatment', 'description': 'Topical bimiralisib for 4 weeks', 'interventionNames': ['Drug: Bimiralisib']}], 'interventions': [{'name': 'Bimiralisib', 'type': 'DRUG', 'description': 'Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks', 'armGroupLabels': ['Bimiralisib - 2 weeks treatment']}, {'name': 'Bimiralisib', 'type': 'DRUG', 'description': 'Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks', 'armGroupLabels': ['Bimiralisib - 4 weeks treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel / Department of Dermatology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TORQUR', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}