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Trial record 2 of 2 for:    Heidelberg Immunotherapeutics

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (MATCH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539483
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Heidelberg ImmunoTherapeutics GmbH

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.


Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: HDIT101 (blinded therapy) 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HDIT101
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)
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.

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.

Placebo Comparator: Placebo to HDIT101
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)
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.




Primary Outcome Measures :
  1. Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months. [ Time Frame: During 12 months treatment phase ]
    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


Secondary Outcome Measures :
  1. Percentage of days with a lesion [ Time Frame: During 12 months treatment phase ]
    Percentage of days with a lesion

  2. Duration of recurrent lesions [ Time Frame: During 12 months treatment phase ]
    Duration of recurrent lesions

  3. Time to first recurrence [ Time Frame: During 12 months treatment phase ]
    Time to first recurrence reported by the patient and verified by the investigator (If no further lesion develops, time to end of study is taken).

  4. Number of aborted lesions [ Time Frame: During 12 months treatment phase ]
    An aborted lesion is a non-ulcerative lesion that does not progress beyond the papule stage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539483


Contacts
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Contact: Bernd Ullrich, PhD +49622167222 ext 36 bernd.ullrich@hditx.de
Contact: Kunz Claudia, PhD +49622167222 ext 39 claudia.kunz@hditx.de

Locations
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Germany
emovis GmbH Recruiting
Berlin, Germany, 10629
Contact: Kerstin Sturm, MD       Herpes_HTX101-03L@emovis.de   
Infektio Research GmbH & Co. KG Recruiting
Frankfurt am Main, Germany, 60596
Contact: Markus Bickel, MD    +49 69 695972 ext 434    studien@infektio-research.de   
bioskin Prüfzentrum Recruiting
Hamburg, Germany, 20095
Contact: Heinrich Siemetzki, MD       studien@bioskin.de   
ICH Study Center GmbH & Co. KG Recruiting
Hamburg, Germany, 20146
Contact: Hans-Juergen Stellbrink, MD       grindel@ich-hamburg.de   
Universitätsklinikum Heidelberg - Medizinische Klinik, Klinische Pharmakologie & Pharmakoepidemiologie Recruiting
Heidelberg, Germany, 69120
Contact: Antje Blank, MD       Klips@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg ImmunoTherapeutics GmbH
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Responsible Party: Heidelberg ImmunoTherapeutics GmbH
ClinicalTrials.gov Identifier: NCT04539483    
Other Study ID Numbers: HTX101-03L
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Labialis
Infections
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases