A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 761
- 试验地点
- 5
- 主要终点
- Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.
研究概览
简要总结
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.
详细描述
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo.
Approximately 138 eligible patients will be randomised at a ratio of 2:1 to topical HDIT or corresponding placebo.
The trial consists of 3 parts: An observation phase (up to 9 months), a treatment phase of 12 months, and a post-trial follow-up phase of additional 12 months: The observation phase ensures that the patient develops a minimum number of lesions during the trial. In the 12 months treatment phase, blinded study treatment consisting of topical HDIT101 or placebo is applied to the patients at the first and second lesion episode. After completion of the treatment phase, patients are followed for additional 12 months for assessment of the development of further lesions (post-trial follow-up phase).
Observation phase (max. 9 months):
Eligible patients suffering from chronic recurrent herpes orolabialis for at least 12 months and reporting ≥ 6 lesions in the last 12 months can enter the observation phase. This part of the study serves for confirmation that patients develop a minimum number of 3 lesions within the 9 months observation period. No study treatment is applied in the observation phase, but standard-of-care treatment (SoC) can optionally be applied. Single swabs should additionally be taken from the lesion for confirmation of HSV-1 positivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Placebo (blinded therapy) (Drug)
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
干预措施: HDIT101 (blinded therapy) (Drug)
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
干预措施: Photo documentation of orolabial herpes lesions (Behavioral)
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
干预措施: Completion of questionnaires (patient-reported outcomes) (Behavioral)
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
干预措施: 28-day swabbing of orolabial region (Procedure)
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
干预措施: Blood drawings (Procedure)
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
干预措施: Photo documentation of orolabial herpes lesions (Behavioral)
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
干预措施: Completion of questionnaires (patient-reported outcomes) (Behavioral)
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
干预措施: 28-day swabbing of orolabial region (Procedure)
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
干预措施: Blood drawings (Procedure)
结局指标
主要结局
Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.
时间窗: 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
次要结局
- 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)