TerminatedPhase 2

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

Stopped: stopped for futility in interim analysis

Germany761 participantsStarted 2020-10-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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. Main Exclusion Criteria: * 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…

What they're measuring

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

Timeframe: During 12 months treatment phase

Trial details

NCT IDNCT04539483

SponsorHeidelberg ImmunoTherapeutics GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31