Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

NCT04539483 | Terminated Phase 2 DMC

• 1 other identifier: HTX101-03L
• Study Type: interventional
• Target: 761
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Herpes simplex virus 1

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.

  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 first IMP treatment

  During 12 months treatment phase

Secondary Outcomes (4)

• Percentage of days with a lesion

  During 12 months treatment phase

• Duration of recurrent lesions

  During 12 months treatment phase

• Time to first recurrence

  During 12 months treatment phase

• Number of aborted lesions

  During 12 months treatment phase

Study Arms (2)

HDIT101

EXPERIMENTAL

Topical application of HDIT101 solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study

Drug: HDIT101 (blinded therapy); Behavioral: Photo documentation of orolabial herpes lesions; Behavioral: Completion of questionnaires (patient-reported outcomes); Procedure: 28-day swabbing of orolabial region; Procedure: Blood drawings

Placebo to HDIT101

PLACEBO COMPARATOR

Topical application of placebo solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study

Drug: Placebo (blinded therapy); Behavioral: Photo documentation of orolabial herpes lesions; Behavioral: Completion of questionnaires (patient-reported outcomes); Procedure: 28-day swabbing of orolabial region; Procedure: Blood drawings

Interventions

HDIT101 (blinded therapy) DRUG

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.

HDIT101

Placebo (blinded therapy) DRUG

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.

Placebo to HDIT101

Photo documentation of orolabial herpes lesions BEHAVIORAL

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

HDIT101; Placebo to HDIT101

Completion of questionnaires (patient-reported outcomes) BEHAVIORAL

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

HDIT101; Placebo to HDIT101

28-day swabbing of orolabial region PROCEDURE

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

HDIT101; Placebo to HDIT101

Blood drawings PROCEDURE

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

HDIT101; Placebo to HDIT101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg ImmunoTherapeutics GmbH: lead

Study Sites (5)

emovis GmbH

Berlin, 10629, Germany

Location

Infektio Research GmbH & Co. KG

Frankfurt am Main, 60596, Germany

Location

bioskin Prüfzentrum

Hamburg, 20095, Germany

Location

ICH Study Center GmbH & Co. KG

Hamburg, 20146, Germany

Location

Universitätsklinikum Heidelberg - Medizinische Klinik, Klinische Pharmakologie & Pharmakoepidemiologie

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: October 8, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)