Chronic recurrent anogenital HSV-2 infection MedDRA version: 20.0 Level: LLT Classification code 10019938 Term: Herpes genitalis System Organ Class: 100000004862
Conditions
Interventions
Product Name: HDIT101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: HDIT101
Other descriptive name: HUMANIZED IgG1 KAPPA MONOCLONAL ANTIBODY
Conce
Sponsors
Heidelberg ImmunoTherapeutics GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of signing informed consent. 2. Signed informed consent for participation in the study. 3. Understanding, ability, and willingness to fully comply with study interventions and restrictions. 4. Seropositive for HSV-2. Previous serology laboratory reports (no PCR) provided by the patient are acceptable. 5. History of chronic recurrent anogenital HSV-2 infection with = 4 outbreaks (= 2 under standard suppressive antiviral therapy) in the last year with no active lesion at time of enrolment. Patients with acute lesion(s) can be enrolled when the previous lesion is healed off. 6. No use of any HSV-suppressant therapy (both approved drugs and non-approved drugs including OTC drugs) including topical applications during trial participation and at least 7 days prior to start of first 28 days swabbing period and/or treatment. 7. Willingness to not use any topical or systemic anti-HSV therapy (both approved drugs and non-approved drugs including OTC) during the study apart from the study medication. Topical anti-HSV therapy of orolabial lesions is allowed. 8. Willingness to not use any topical HSV treatment upon lesion development as well as avoid any manipulation or physical impact, e.g., cooling of the lesion particularly in the prodromal stage. 9. Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator. 10. Women of child-bearing potential (WCBP) must have a negative beta-human chorionic gonadotropin (ß-HCG) urine and/or blood test at screening and within 72 hours before receiving study treatment. 11. Willingness to use two independent effective contraceptive methods for 3 months after Visit 1. Male participants and partners of female participants have to use a condom during sexual intercourse or intimacy to reduce the probability of sexually transmitted infection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients who do not develop a lesion during the 28-day swabbing period and 3 months (90 days) afterwards (i.e., within 4 months after screening) except patients who have reported lesions to the investigator within this screening period but were not able to be randomized due to timely restrictions (e.g. COVID-19 travel restrictions, holidays, vacation etc.). Those patients can still be randomized after additional 30 days (150 days in total). 2. Medical history or current physical illnesses/medical conditions that constitute an unacceptable risk for study participation in the judgment of the investigator (e.g., clinically significant autoimmune disorder, active infection, uncontrolled medical conditions or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety or put the study outcomes at risk, such as uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled coronary heart disease, uncontrolled psychiatric condition). 3. Patients with herpes keratitis. 4. Immunomodulatory therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids within 28 days before start of study treatment. 5. Any condition that precludes the sampling of up to 200 mL (additional 150 mL in case of optional participation for exploratory objective (T-cell response) blood over the duration of the study. 6. Known resistance to or intolerance of valaciclovir or active substance or excipients of the study medication. 7. Positive HIV antibody screen, hepatitis B virus (HBV) infection screen, or hepatitis C virus (HCV) infection screen. 8. Any known history of severe allergic or anaphylactic reactions. 9. Participation in any clinical study within the last 30 days prior to enrolment. 10. Prior treatment with HDIT101 in this or other clinical study . 11. Pregnant or breast-feeding women. 12. Prior malignant disease (except basal cell carcinoma or carcinoma in situ) which has not been successfully cured more than 5 years before enrolment. 13. Hemoglobin (Hb) upper limit of normal (ULN) x 2, except patients with known Morbus Meulengracht. 16. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > ULN x 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of single dose of HDIT101 versus episodic SoC treatment with valaciclovir in patients with chronic recurrent anogenital HSV-2 infection as measured by the percentage of days with lesion(s) during the study (calculated as number of days with lesion, except the lesion episode at randomization, divided by the number of days in the study after IMP infusion).;Secondary Objective: Key secondary objectives of the study are to compare the efficacy of single dose of HDIT101 versus episodic SoC treatment with valaciclovir with respect to: • Time after IMP infusion to first recurrence of lesion(s) • Recurrence rate • Duration of lesion(s) • Disease-specific symptoms • Herpes outbreak impact on daily life • Patient’s QoL Other study secondary objectives are: • To compare safety and tolerability between the two treatment groups • To compare HSV-2 copy numbers from HSV DNA positive samples (swabs) between the two treatment groups • To assess the immunogenicity of HDIT101 (anti-drug antibodies [ADA]) • To determine the PK profile of HDIT101 in patients with HSV-2 infection.;Primary end point(s): Percentage of days with lesion(s) per treatment group, except the lesion episode at randomization, calculated as the number of days with lesion divided by the number of study days after IMP infusion. A lesion is defined as presence of lesion with HSV lesion score 2-7.;Timepoint(s) of evaluation of this end point: Visit 1 and Unscheduled visit in case of new lesion (and if applicable on the following days until lesion healing) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Visit (V) 1 and unscheduled visit in case of new lesion; From first to last day of symptoms; Herpes Symptom Checklist (HSC) questionnaire and Herpes Outbreak Impact Questionnaire (HOIQ): V1 and unscheduled visit in case of new lesion; from first to last day of symptoms; Recurrent Genital Herpes QoL (RGHQoL) questionnaire: V1 and V7; AEs/SAEs: every visit; laboratory tests: V1, V2, V4, V6 and V7; vital signs: V1, V2, V4, V6 and V7; ECG: V1 and V7; Swabs: Screening +28 days, V1 +28 days, V6 +28 days, unscheduled Visit +28 days in case of new lesion; ADA: V1, V2, V4, V6, V7 and unscheduled Visit in case of new lesion (if prior to Day 15 (V2), no ADA sample); PK: V1, V2, V4, V6, V7 and unscheduled Visit in case of new lesion;Secondary end point(s): Key Secondary Endpoints: • Time to first recurrence of lesion (HSV lesion score 2-7) reported by the patient and verified by the investigator • Recurrence rate of lesions (defined as number of recurrences divided by the total number of study days after IMP infusion). • Duration of recurrent lesions (calculated as consecutive days with lesions of HSV score 2-7). • Disease-specific symptoms assessed by Herpes Symptom Checklist (HSC) questionnaire. • Herpes outbreak impact assessed by Herpes Outbreak Impact Questionnaire (HOIQ). • Change in QoL between baseline and EoS assessed by the Recurrent Genital Herpes QoL (RGHQoL) questionnaire. Other Secondary Endpoints: • Safety and tolerability of HDIT101 versus SoC based on incidence, severity and relationship of treatment-related AEs and SAEs, laboratory tests, vital signs and electrocardiogram (ECG). • HSV copy numbers from HSV DNA positive swabs. • ADA • Non-compartmental PK characteristics of HDIT101 • Population PK evaluation. | — |
Countries
Germany
Contacts
Public ContactStefan Schöffel
Heidelberg ImmunoTherapeutics GmbH
Outcome results
None listed