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
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|ClinicalTrials.gov Identifier: NCT04714060|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : May 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Genital Herpes||Biological: UB-621||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||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|
|Estimated Study Start Date :||October 1, 2023|
|Estimated Primary Completion Date :||October 1, 2024|
|Estimated Study Completion Date :||January 31, 2025|
Experimental: cohort 1
2.5 mg/kg UB-621 group
mAb by SC administration
Experimental: cohort 2
5 mg/kg UB-621 group
mAb by SC administration
- Proportion of subjects with episodes before and after UB-621 treatment (self-comparison) [ Time Frame: 16 weeks ]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.
- Lesion rate [ Time Frame: 16 weeks ]Lesion rate is calculated as the number of days with lesion divided by the number of study days.
- Duration of recurrent lesions [ Time Frame: 16 weeks ]Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
- Recurrence rate [ Time Frame: 16 weeks ]Recurrence rate is defined as number of recurrences divided by the total number of study days.
- Time to first recurrence of lesion [ Time Frame: 16 weeks ]Time to first recurrence of lesion as reported by patient and verified by investigator.
- HSV-2 shedding rate. [ Time Frame: 8 weeks ]Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.
- Clinical and Subclinical HSV-2 Shedding Rates [ Time Frame: 8 weeks ]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.
- Rate of HSV-2 Shedding Episodes [ Time Frame: 8 weeks ]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.
- HSV-2 viral load [ Time Frame: 8 weeks ]Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714060
|Contact: Linda Shih, DVM||+886 36684800 ext firstname.lastname@example.org|