Chronic Herpes Simplex Virus-1 Infection MedDRA version: 21.1 Level: LLT Classification code 10073933 Term: Herpes simplex oral System Organ Class: 100000004862 MedDRA version: 22.0 Level: LLT Classification code 10082141 Term: Herpes simplex labialis System Organ Class: 100000004862
Conditions
Interventions
Product Code: HDIT101
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: HDIT101
Current Sponsor code: HDIT101
Other descriptive name: HUMANIZED IGG1 MONOCLONAL ANTIBODY
Concentration unit: mg
Sponsors
Heidelberg ImmunoTherapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to provide written, personally signed and dated informed consent to participate in the study. 2. Age = 18 years at the time of signing informed consent. 3. Understanding, ability, and willingness to fully comply with study interventions and restrictions. 4. Seropositive for HSV-1 at screening or if documented within 2 years prior enrolment with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year. 5. Three confirmed lesions within 9 months after enrolment. 6. Willingness not to use any HSV-suppressant therapy (both approved drugs and non-approved drugs including over-the-counter [OTC] drugs, e.g. herpes patches or supplemental dietary anti-herpetic treatments) except 5% aciclovir cream as optional standard of care (with the exception of the first two outbreaks in the treatment phase). 7. Willingness to remove beard or lip piercings if lesion boundaries in this region cannot be evaluated and topical treatment of the entire lesion is compromised (according to judgement of investigator). 8. Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions to the study site and to complete questionnaires upon recognition of first symptoms during the study. 9. Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator. 10. Willingness to use contraceptive methods for 30 days after each treatment (as further described in section 4.5). 11. Availability of a mobile phone, tablet or other smart device with a camera, connection to the internet and willingness to use this device for documentation of patient-reported outcomes and photo upload. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: 1. Patients who do not develop at least 3 lesions of stage 3 or higher during the 9 months observation phase or do not develop any lesion within 150 days from enrolment visit. 2. Patients with herpes keratitis. 3. Requirement for immunosuppressive therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids. 4. Any condition that precludes the sampling of up to 215 mL blood over the duration of the study. 5. Any known clinically relevant allergies to drugs or any history of severe allergic or anaphylactic reactions. 6. Known intolerance to active substance or excipients of the investigational medicinal product or comparator. 7. Positive human immunodeficiency virus (HIV) antibody screen, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. 8. Treatment with an investigational drug in any clinical study within the last 30 days prior to enrolment in this study. 9. Prior treatment with HDIT101, e.g. in this or another clinical study. 10. Prior vaccination with an HSV type 1/2 vaccine (e.g. experimental) within the last 2 years prior screening. 11. Pregnant or breast-feeding women. 12. Prior malignant disease (except basal cell carcinoma in situ) if not successfully cured more than 5 years before enrolment. 13. Patients who have abnormal skin conditions which are considered clinically significant according to the assessment of the investigator (e.g., acne, eczema, rosacea, psoriasis, albinism, chronic vesiculo-bullous disorders, atopic dermatitis, history of eczema herpeticum). 14. Any clinically relevant medical history or current physical or psychiatric illnesses/medical conditions that constitute an unacceptable risk for study participation or make the participant unlikely to fully complete the study in the judgment of the Investigator. This especially applies to currently medicated psychiatric illnesses since this poses an additional risk for pharmacodynamic interaction with IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of topical HDIT101 in patients with chronic recurrent orolabial HSV-1 infection and at least 6 lesion outbreaks/year by comparing the number of recurrences of orolabial lesions for 12 months after topical administration of HDIT101 or corresponding placebo two times daily for two consecutive days to the first and second orolabial lesion after randomisation.;Secondary Objective: Key Secondary Objectives: To compare the following between the two treatment arms: • Percentage of days with lesion in the 12 months treatment period. • Duration of lesion(s) for 12 months. • Time after IMP application to first recurrence of a lesion (lesion no. 4) Secondary Objectives: • Safety and tolerability between the two treatment groups. • Number of patients with aborted lesions (non-ulcerative lesion) • Number of recurrences of orolabial lesions for 24 months. • To evaluate the number and time of recurrences (up to 9 months) prior to start of treatment versus 12-month treatment phase and 12 months follow up phase (intra-patient control). • Disease-specific symptoms. • Patient’s quality of life (QoL). • Pharmacokinetic (PK) profile of locally applied HDIT101;Primary end point(s): Number of recurrences after topical HDIT101 versus placebo after 12 months. A lesion is considered as such if rated 3-7 according the HSV lesion score (grade 2 is rated as “aborted lesion”). The recurrence rate is defined as number of recurrences in the 12 months treatment phase divided by the total number of study days (in the 12 months treatment phase) after IMP treatment for lesion 3.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 months or as indicated;Secondary end point(s): Key Secondary Endpoints: • Percentage of days with a lesion in the 12 months treatment period. • Mean duration of recurrent lesions (calculated as consecutive days with lesions of HSV score = 3-7). • Time to first recurrence of lesion (= lesion no. 4; HSV lesion score must be 3-7) reported by the patient and verified by the investigator. Other Secondary Endpoints: • Safety and tolerability based on incidence, severity and relationship of treatment-related adverse events (AEs) and serious adverse events (SAEs), laboratory tests and vital signs. • Number of aborted lesions in the 12-months treatment period. • Number of recurrences after topical HDIT101 versus placebo after 24 months (will be done after finalization of follow-up period, not part of the CSR). • Number of recurrences before and after topical HDIT101 in pre-defined time frames 9 month pre-treatment (day 30/120/240/overall), 12 (day 30/120/240/365/overall) month treatment and also in the 12 month follow-up phase (day 30/120/240/365/overall). • Herpes impact on daily life assessed by the cold sores questionnaire. • Disease-specific symptoms assessed by patient diary. • Change in QoL between baseline and end of study (EoS) assessed by patient diary (DLQI/mDLQI). • PK profile of HDIT101 (in selected sites only). | — |
Countries
Germany
Contacts
Public ContactDr. Bernd Ullrich
Heidelberg ImmunoTherapeutics
Outcome results
None listed