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    Summary
    EudraCT Number:2020-000926-24
    Sponsor's Protocol Code Number:HTX101-03L
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-03-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2020-000926-24
    A.3Full title of the trial
    A Randomised, Double-Blind Phase II Trial of Topical HDIT101 versus Placebo in Patients with Chronic Recurrent HSV-1 Infection and Orolabial Lesion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of recurrent cold sores caused by Herpes Simplex virus-1 with HDIT101 (an antibody) or placebo
    A.3.2Name or abbreviated title of the trial where available
    MATCH-1; Monoclonal Antibody Therapy against Chronic Herpes Simplex Virus 1 Infection
    A.4.1Sponsor's protocol code numberHTX101-03L
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHeidelberg ImmunoTherapeutics
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHeidelberg ImmunoTherapeutics
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeidelberg ImmunoTherapeutics
    B.5.2Functional name of contact pointDr. Bernd Ullrich
    B.5.3 Address:
    B.5.3.1Street AddressMax-Jarecki-Str. 21
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69115
    B.5.3.4CountryGermany
    B.5.4Telephone number+496221391936
    B.5.6E-mailbernd.ullrich@hditx.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code HDIT101
    D.3.4Pharmaceutical form Cutaneous liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHDIT101
    D.3.9.2Current sponsor codeHDIT101
    D.3.9.3Other descriptive nameHUMANIZED IGG1 MONOCLONAL ANTIBODY
    D.3.9.4EV Substance CodeSUB33338
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous liquid
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Herpes Simplex Virus-1 Infection
    E.1.1.1Medical condition in easily understood language
    Recurrent Herpes Simplex Virus outbreaks
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10073933
    E.1.2Term Herpes simplex oral
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082141
    E.1.2Term Herpes simplex labialis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical efficacy of topical HDIT101 in patients with chronic recurrent orolabial HSV-1 infection and at least 6 lesion outbreaks/year by comparing the number of recurrences of orolabial lesions for 12 months after topical administration of HDIT101 or corresponding placebo two times daily for two consecutive days to the first and second orolabial lesion after randomisation.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    To compare the following between the two treatment arms:
    • Percentage of days with lesion in the 12 months treatment period.
    • Duration of lesion(s) for 12 months.
    • Time after IMP application to first recurrence of a lesion (lesion no.

    Secondary Objectives:
    • Safety and tolerability between the two treatment groups.
    • Number of recurrences of orolabial lesions for 24 months.
    • To evaluate the number and time of recurrences (up to 9 months) prior to start of treatment versus 12-month treatment phase and 12 months follow up phase (intra-patient control).
    • Disease-specific symptoms.
    • Patient’s quality of life (QoL).
    • Pharmacokinetic (PK) profile of locally applied HDIT101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to provide written, personally signed and dated informed consent to participate in the study.
    2. Age ≥ 18 years at the time of signing informed consent.
    3. Understanding, ability, and willingness to fully comply with study interventions and restrictions.
    4. Seropositive for HSV-1 at screening or if documented within 2 years prior enrolment with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year.
    5. Three confirmed lesions within 9 months after enrolment.
    6. Willingness not to use any HSV-suppressant therapy (both approved drugs and non-approved drugs including over-the-counter [OTC] drugs, e.g. herpes patches or supplemental dietary anti-herpetic treatments) except 5% aciclovir cream as optional standard of care (with the exception of the first two outbreaks in the treatment phase).
    7. 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).
    8. Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions to the study site and to complete questionnaires upon recognition of first symptoms during the study.
    9. Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
    10. Willingness to use contraceptive methods for 30 days after each treatment (as further described in section 4.5).
    11. 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.
    E.4Principal exclusion criteria
    1. 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.
    2. Patients with herpes keratitis.
    3. Requirement for immunosuppressive therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids.
    4. Any condition that precludes the sampling of up to 215 mL blood over the duration of the study.
    5. Any known clinically relevant allergies to drugs or any history of severe allergic or anaphylactic reactions.
    6. Known intolerance to active substance or excipients of the investigational medicinal product or comparator.
    7. Positive human immunodeficiency virus (HIV) antibody screen, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
    8. Treatment with an investigational drug in any clinical study within the last 30 days prior to enrolment in this study.
    9. Prior treatment with HDIT101, e.g. in this or another clinical study.
    10. Prior vaccination with an HSV type 1/2 vaccine (e.g. experimental) within the last 2 years prior screening.
    11. Pregnant or breast-feeding women.
    12. Prior malignant disease (except basal cell carcinoma in situ) if not successfully cured more than 5 years before enrolment.
    13. Patients who have abnormal skin conditions which are considered clinically significant according to the assessment of the investigator (e.g., acne, eczema, rosacea, psoriasis, albinism, chronic vesiculo-bullous disorders, atopic dermatitis, history of eczema herpeticum).
    14. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Number of recurrences after topical HDIT101 versus placebo after 12 months. A lesion is considered as such if rated 3-7 according the HSV lesion score (grade 2 is rated as “aborted lesion”). 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 IMP treatment for lesion 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    • Percentage of days with a lesion in the 12 months treatment period.
    • Duration of recurrent lesions (calculated as consecutive days with lesions of HSV score ≥ 3-7).
    • Time to first recurrence of lesion (= lesion no. 4; HSV lesion score must be 3-7) reported by the patient and verified by the investigator.
    • Number of aborted lesions in the 12-months treatment period.
    Other Secondary Endpoints:
    • Safety and tolerability based on incidence, severity and relationship of treatment-related adverse events (AEs) and serious adverse events (SAEs), laboratory tests and vital signs.
    • Number of recurrences after topical HDIT101 versus placebo after 24 months.
    • Number of recurrences before and after topical HDIT101 in pre-defined time frames 9 month pre-treatment (day 30/120/240/overall), 12 (day 30/120/240/365/overall) month treatment and also in the 12 month follow-up phase (day 30/120/240/365/overall).
    • Herpes impact on daily life assessed by the cold sores questionnaire.
    • Disease-specific symptoms assessed by patient diary.
    • Change in QoL between baseline and end of study (EoS) assessed by patient diary (DLQI/mDLQI).
    • PK profile of HDIT101 (in selected sites only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months or as indicated
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the study is “Last patient last visit” (LPLV) which is defined as the timepoint when the last patient across all sites has completed the last end-of-study visit (= scheduled visit 7 at the end of the treatment period).
    The follow-up by phone is not considered part of the trial, but will be done as post-trial follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state138
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After a patient has ceased his/her participation in the study, his/her medical doctor will offer the most appropriate treatment currently available.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-04-24
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