Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included.

The patients need to present with 3 herpes lesions within a 9 months observation phase. With the occurrence of the third lesion, the patients will enter the 12 months treatment phase and will be randomized in a 2:1 ratio to topical HDIT or placebo applied over 2 days. A potential fourth lesion will also be treated with the blinded study medication and additional lesions will be documented.

In a 12 months post-trial follow-up phase, further information on the occurence of lesions will be collected 4 times by phone.

Study duration per patient will be up to 21 months plus 12 months post-trial follow-up by phone. Patients need to come for study visits up to 9 times.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg ImmunoTherapeutics GmbH

Criteria

Main Inclusion Criteria:

• Ability to provide written, personally signed and dated informed consent

• Age ≥ 18 years

• Understanding, ability, and willingness to fully comply with study interventions and restrictions.

• Seropositive for HSV-1 at screening with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year.

• Three confirmed lesions within 9 months after enrolment.

• Willingness not to use any HSV-suppressant therapy except 5% aciclovir cream as optional standard of care

• 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).

• Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions and to complete questionnaires during the study.

• Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.

• Willingness to use contraceptive methods

• Availability of a mobile phone with a camera, connection to the internet and willingness to use this device for documentation of patient-reported outcomes and photo upload.

Main Exclusion Criteria:

• Patients who do not develop at least 3 lesions during the 9 months observation phase.

• Herpes keratitis.

• Requirement for immunosuppressive therapy and/or steroids.

• Any known allergies to drugs or any history of severe allergic or anaphylactic reactions OR any other clinically significant allergies (mild forms, e.g. mild hay fever, are acceptable, if currently asymptomatic without treatment).

• Positive HIV antibody screen, active hepatitis B virus or active hepatitis C virus infection.

• Treatment with an investigational drug in any clinical study within the last 30 days prior to enrolment in this study.

• Prior treatment with HDIT101, e.g. in this or another clinical study.

• Prior vaccination with an HSV type 1/2 vaccine (e.g. experimental) within the last 2 years prior screening.

• Pregnant or breast-feeding women.

• Prior malignant disease (except basal cell carcinoma in situ) if not successfully cured more than 5 years before enrolment.

• Patients who have abnormal skin conditions which are considered clinically significant according to the assessment of the investigator

• 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.