Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent orofacial herpes infections.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Labo'Life Belgium

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

19 Jun 2024 → ongoing

Decision date (initial)

2024-06-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514358-56-00

EudraCT number

2019-001085-15

ClinicalTrials.gov

NCT04065971

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.

Secondary objectives 1

1. Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects: a) number of episodes at 6 months, b) time to first episode during the treatment, c) duration of episodes, d) symptomatology during the entire relapse time, e) use of Rescue Medication (RM), f) evaluation of impact on the quality of life, g) safety issues.

Conditions and MedDRA coding

Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12 months period prior to study entry)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Man or woman aged 16-80 years, - Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months’ period (prior to the study entry), - Woman of childbearing age under effective contraception, - Patient reporting a current stable sexual relationship (steady sexual partner during study duration), - Patient having faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form.

Exclusion criteria 1

1. - Pregnant or breastfeeding woman, - Patient under immunotherapy (including immunosuppressive treatment) or microimmunotherapy received during last previous 6 months, - Patient who had a suppressive antiviral therapy during last month, - Patient who wishes to continue his/her suppressive antiviral therapy, - Patient with known lactose intolerance, galactose intolerance, lactase Lapp deficiency or glucose-galactose malabsorption syndrome - Patient who participated in a clinical study in the previous 3-month period, - Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy, - Patient under listed homeopathic or phytotherapy treatment, - Patient using or addicted to recreational drugs. (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.

Secondary endpoints 1

1. a.1) Remaining herpes infection recurrence free 12 months after treatment initiation, a.2) Remaining herpes infection recurrence free 6 months after treatment initiation, a.3) Number of episodes of herpes infection observed at 6 months, b) Time to first recurrence of herpes infection during the treatment, c) Mean duration of episodes, d) Level of pain during episodes, e) Use of Rescue Medication, f) Quality of Life, e) Occurrence of AEs and SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Labo'Life Belgium

Sponsor organisation

Labo'Life Belgium

Address

Avenue D'Ecolys 2 Bus 36

City

Namur

Postcode

5020

Country

Belgium

Scientific contact point

Organisation

Labo'Life Belgium

Contact name

Laura Ferté Clinical Project Manager

Public contact point

Organisation

Labo'Life Belgium

Contact name

Laura Ferté Clinical Project Manager

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications