Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

Launched by HEIDELBERG IMMUNOTHERAPEUTICS GMBH · Aug 31, 2020

Keywords

ClinConnect Summary

This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo.

Approximately 138 eligible patients will be randomised at a ratio of 2:1 to topical HDIT or corresponding placebo.

The trial consists of 3 parts: An observation phase (up to 9 months), a treatment phase of 12 months, and a post-trial follow-up phase of additional 12 months: The observation phase ensures that the patient develops a minimum number of lesions during the trial. In the 12 months treatment phase, blinded study treatment consisting of topical HDIT101 or placebo is appli...

Gender

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Eligibility 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 for 30 days after each treatment.
• • 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.
• Main Exclusion Criteria:
• • 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.
• • Herpes keratitis.
• • Requirement for immunosuppressive therapy and/or steroids.
• • Any known clinically relevant allergies to drugs or any history of severe allergic or anaphylactic reactions
• • 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. This especially applies to currently medicated psychiatric illnesses since this poses an additional risk for pharmacodynamic interaction with IMP.