Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT04714060
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006558', 'term': 'Herpes Genitalis'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HSV-2 shedding rate.', 'timeFrame': '8 weeks', 'description': 'Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.'}, {'measure': 'Clinical and Subclinical HSV-2 Shedding Rates', 'timeFrame': '8 weeks', 'description': 'Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.'}, {'measure': 'Rate of HSV-2 Shedding Episodes', 'timeFrame': '8 weeks', 'description': 'The rate of HSV-2 shedding episodes is the number of onsets of shedding episodes divided by the total number of days with swabs collected. Shedding episodes are defined as consecutive HSV-2 positive swab results including no more than 1 consecutive negative result or missed swab. The episodes are preceded and followed by 2 consecutive negative swab results.'}, {'measure': 'HSV-2 viral load', 'timeFrame': '8 weeks', 'description': 'Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)', 'timeFrame': '16 weeks', 'description': 'Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. Primary endpoint is the self-comparison of proportion of subjects with episodes before and after UB-621 treatment.'}], 'secondaryOutcomes': [{'measure': 'Lesion rate', 'timeFrame': '16 weeks', 'description': 'Lesion rate is calculated as the number of days with lesion divided by the number of study days.'}, {'measure': 'Duration of recurrent lesions', 'timeFrame': '16 weeks', 'description': 'Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.'}, {'measure': 'Recurrence rate', 'timeFrame': '16 weeks', 'description': 'Recurrence rate is defined as number of recurrences divided by the total number of study days.'}, {'measure': 'Time to first recurrence of lesion', 'timeFrame': '16 weeks', 'description': 'Time to first recurrence of lesion as reported by patient and verified by investigator.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Genital Herpes']}, 'descriptionModule': {'briefSummary': 'A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be at least 18 years of age inclusive.\n* Subject must be HSV-2 seropositive\n* Subjects have a history of recurrent genital herpes in the past year\n* Subjects have a negative result on the HIV Ab/Ag assay\n* Subjects must agree to use contraception during study participation\n* Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks period after the administration of study drug.\n* Subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area.\n* Subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the HSV lesion score, and to record in the patient dairy\n* Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.\n\nExclusion Criteria:\n\n* Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.\n* History or current evidence of malignancy except for a localized non-melanoma skin cancer\n* Known immunosuppression\n* Exposure to HSV vaccine\n* Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)\n* Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study\n* Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.\n* Renal impairment and/or hepatic impairment\n* ECG abnormalities of clinical relevance or cardiovascular conditions\n* Abnormal blood tests according to "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial "in the Guidance for Industry, 2007:\n\n 1. albumin\\<3 g/dl\n 2. ALP\\>2.5\\*ULN\n 3. ALT\\>2.5\\*ULN\n 4. AST\\>2.5\\*ULN\n 5. Bilirubin\\>1.5\\*ULN\n 6. CPK\\>1.5\\*ULN\n 7. rGGT\\>2.5\\*ULN\n 8. Hemoglobin: female\\<11 g/dl; male\\<12.5 g/dl\n 9. platelet\\<125\\*10E3/ul\n 10. WBC\\<2.5\\*10E3/ul or\n 11. ANC\\<1.5\\*10E3/ul'}, 'identificationModule': {'nctId': 'NCT04714060', 'briefTitle': 'UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals', 'organization': {'class': 'INDUSTRY', 'fullName': 'UBP Greater China (Shanghai) Co., Ltd'}, 'officialTitle': 'A Randomized, Single-blind, Dose-selected Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection', 'orgStudyIdInfo': {'id': 'UBP-A228-HSV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cohort 1', 'description': '2.5 mg/kg UB-621 group', 'interventionNames': ['Biological: UB-621']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 2', 'description': '5 mg/kg UB-621 group', 'interventionNames': ['Biological: UB-621']}], 'interventions': [{'name': 'UB-621', 'type': 'BIOLOGICAL', 'description': 'mAb by SC administration', 'armGroupLabels': ['cohort 1', 'cohort 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Linda Shih, DVM', 'role': 'CONTACT', 'email': 'linda.shih@unitedbiopharma.com', 'phone': '+886 36684800', 'phoneExt': '3851'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UBP Greater China (Shanghai) Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}