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Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

NCT04539483 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 761

Last updated 2023-09-25

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Heidelberg ImmunoTherapeutics GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539483 on ClinicalTrials.gov