Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:35 AM
Study NCT ID:
NCT07449156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory lesion counts', 'timeFrame': 'Week 16', 'description': 'Absolute change from Baseline in the number of inflammatory acne lesions'}, {'measure': "Investigator's global assessment (IGA) - change from Baseline", 'timeFrame': 'Week 16', 'description': 'Absolute change in IGA score from Baseline \\[scores: 0-4; 0=clear, 4=severe\\]'}], 'secondaryOutcomes': [{'measure': "Investigator's global assessment (IGA) - percentage of subjects with improvement", 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \\[scores: 0-4; 0=clear, 4=severe\\]'}, {'measure': 'Change in inflammatory lesion counts', 'timeFrame': 'Week 16', 'description': 'Percentage change from Baseline in the number of inflammatory acne lesions'}, {'measure': "Investigator's global assessment (IGA) - percentage of subjects with improvement", 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'Percentage of subjects with an IGA score of "clear" or "almost clear"'}, {'measure': "Investigator's global assessment (IGA) - percentage of subjects with improvement", 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'Percentage of subjects with an IGA score of "clear" or "almost clear" and a reduction of at least two-grade compared to the baseline IGA score.'}, {'measure': 'Incidence of AEs and serious adverse events (SAEs))', 'timeFrame': 'Baseline to week 16', 'description': 'Incidence of AEs and SAEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.', 'detailedDescription': 'The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.\n\n5\\. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.\n\nExclusion Criteria:\n\n* 1\\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.\n\n 3\\. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 7. History of recurrent or recent serious infection; 8. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Any reason why, in the opinion of the investigator, the patient should not participate.'}, 'identificationModule': {'nctId': 'NCT07449156', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Huaota Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).', 'orgStudyIdInfo': {'id': 'HB0043-AV-0-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HB0043', 'description': 'Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14.', 'interventionNames': ['Drug: HB0043']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants randomized to Arm 2 will receive placebo via subcutaneous injection biweekly from Week 0 to Week 6, followed by HB0043 via subcutaneous injection biweekly from Week 8 to Week 14.', 'interventionNames': ['Drug: HB0043', 'Drug: Placebo']}], 'interventions': [{'name': 'HB0043', 'type': 'DRUG', 'description': '300mg', 'armGroupLabels': ['HB0043', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '300mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Wu Wu', 'role': 'CONTACT', 'email': 'xueqiong.wu@huaota.com', 'phone': '+86-15040367023'}], 'facility': 'Dermatology Hospital affiliated to Shandong First Medical University,', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Huaota Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dermatology Hospital affiliated to Shandong First Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}