Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

PHASE2TerminatedINTERVENTIONAL
Enrollment

761

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

May 31, 2023

Study Completion Date

May 31, 2023

Conditions
Herpes Labialis
Interventions
DRUG

HDIT101 (blinded therapy)

Patients will be treated with with topical HDIT101 (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.

DRUG

Placebo (blinded therapy)

Patients will be treated with with topical placebo (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.

BEHAVIORAL

Photo documentation of orolabial herpes lesions

Patients will be asked to document their orolabial lesions with photos by using their smart phone

BEHAVIORAL

Completion of questionnaires (patient-reported outcomes)

Patients will be asked to document their health status in questionnaires by using their smart phone

PROCEDURE

28-day swabbing of orolabial region

Patients will be asked to complete 3 episodes of 28-day swabbing of orolabial lesions

PROCEDURE

Blood drawings

Blood will be drawn for e.g. safety lab, HSV-analysis, pharmacokinetic etc.

Trial Locations (5)

10629

emovis GmbH, Berlin

20095

bioskin Prüfzentrum, Hamburg

20146

ICH Study Center GmbH & Co. KG, Hamburg

60596

Infektio Research GmbH & Co. KG, Frankfurt am Main

69120

Universitätsklinikum Heidelberg - Medizinische Klinik, Klinische Pharmakologie & Pharmakoepidemiologie, Heidelberg

All Listed Sponsors
lead

Heidelberg ImmunoTherapeutics GmbH

INDUSTRY