Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06916793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068538', 'term': 'Dutasteride'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of hair Changes', 'timeFrame': 'Baseline, Week 24', 'description': 'from Baseline at Week24 of total number of hair changes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia', 'detailedDescription': 'The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male of age 18-50 years\n* Clinical Diagnosis of Androgenetic Alopecia\n* Written informed consent\n\nKey Exclusion Criteria:\n\n* Other types of Alopecia or other diseases that can cause hair loss\n* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis\n* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator\n* Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose'}, 'identificationModule': {'nctId': 'NCT06916793', 'briefTitle': 'A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'A107_03AGA2318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group1', 'description': 'CKD-843 dose#1 + Placebo of Dutasteride Capsule', 'interventionNames': ['Drug: CKD-843 dose#1', 'Drug: Placebo of Dutasteride Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Test Group2', 'description': 'CKD-843 dose#2 + Placebo of Dutasteride Capsule', 'interventionNames': ['Drug: CKD-843 dose#2', 'Drug: Placebo of Dutasteride Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-controlled Group', 'description': 'Placebo of CKD-843 dose + Placebo of Dutasteride Capsule', 'interventionNames': ['Drug: Placebo of CKD-843 dose', 'Drug: Placebo of Dutasteride Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active-controlled Group', 'description': 'Placebo of CKD-843 dose + Dutasteride Capsules', 'interventionNames': ['Drug: Placebo of CKD-843 dose', 'Drug: Dutasteride Capsules']}], 'interventions': [{'name': 'CKD-843 dose#1', 'type': 'DRUG', 'description': 'IM injection every 3 months for 12 months', 'armGroupLabels': ['Test Group1']}, {'name': 'CKD-843 dose#2', 'type': 'DRUG', 'description': 'IM injection every 3 months for 12 months', 'armGroupLabels': ['Test Group2']}, {'name': 'Placebo of CKD-843 dose', 'type': 'DRUG', 'description': 'IM injection every 3 months for 12 months', 'armGroupLabels': ['Active-controlled Group', 'Placebo-controlled Group']}, {'name': 'Dutasteride Capsules', 'type': 'DRUG', 'description': 'oral, once daily, 12 months', 'armGroupLabels': ['Active-controlled Group']}, {'name': 'Placebo of Dutasteride Capsule', 'type': 'DRUG', 'description': 'oral, once daily, 12 months', 'armGroupLabels': ['Placebo-controlled Group', 'Test Group1', 'Test Group2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'OhSang Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'oskwon@snu.ac.kr', 'phone': '+2-2072-2417'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'OhSang Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'oskwon@snu.ac.kr', 'phone': '+2-2072-2417'}], 'overallOfficials': [{'name': 'OhSang Kwon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}