Lyme borreliosis MedDRA version: 15.1 Level: LLT Classification code 10067559 Term: Lyme borreliosis System Organ Class: 100000004862
Conditions
Interventions
Product Name: SHB004
Pharmaceutical Form: Gel
INN or Proposed INN: Azithromycin
CAS Number: 83905-01-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Pharmaceutical
Sponsors
Ixodes AG.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent by the subject before any study procedure is performed. 2. Males or females aged = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
Exclusion criteria: 1. Subjects who have treated the site of the index tick bite with a topical formulation of an antibiotic other than SHB004 gel. Administration of a topical antibiotic other than SHB004 outside the area of tick bite is allowed (e.g. ophthalmic or otic applications, etc). 2. Subjects who received parenteral or oral antibiotic treatment within 10 days prior to enrollment. 3. Subjects who have a skin score according to Appendix 1 of this protocol grading 3 or worse at baseline. 4. Subjects with a history of allergic reaction or hypersensitivity to macrolide antibiotics (e.g. erythromycin, azithromycin) characterized e.g. by rash, itching, difficulty in breathing or anaphylaxis. 5. Subjects with a history of autoimmune diseases (e.g. rheumatoid arthritis or lupus erythematosus), history or clinical signs of syphilis, active herpes virus infection, subjects under immunosuppressive therapy (prescription drugs only), collagen vascular or immunodeficiency disease, or with a known active infectious mononucleosis (please note, that subjects reporting a past infection are not excluded, only those reporting a current infection). 6. Concurrent systemic steroid therapy. Inhaled steroids are allowed. Topical steroids are allowed when applied at least 10 cm apart from the index tick bite site. 7. Treatment with systemic steroids, other immunomodulatory drugs, or cytostatics within 30 days before enrollment. 8. History of Borreliosis / Lyme disease during the previous 12 months or positive test for antibodies against Borrelia s.l. (seroconverted) as assessed within the last two years prior to enrollment (only the most recent antibody test has to be taken into account; if this latest test is negative the subject is not to be excluded for this reason). 9. Subjects presenting with multiple tick bites at screening/baseline visit. 10. Subjects unable to spot the site of the index tick bite at screening/baseline visit. 11. Subjects who have a history of one or more tick bites within 60 days prior to randomization (except for the current tick bite qualifying for this study). 12. Concurrent tick-borne diseases, such as babesiosis or ehrlichiosis. 13. Any other drug allergy or condition or significant medical problem which in the opinion of the investigator places the subject at unacceptable risk or does not allow the subject to follow study procedures as planned. 14. Have received treatment with any other investigational drug, and/or have participated in another clinical study within 30 days before screening. 15. Are pregnant or a nursing mother. 16. Have a history of, or known current problems with drug or alcohol abuse. (Subject with a history of abuse [drug and/or alcohol], but who have been observing a strict abstinence for at least 1 year will be allowed to participate). 17. Have a history or suspicion of unreliability, poor cooperation or non-compliance with medical treatment. 18. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confused state of the subject. 19. Have previously been enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate a reduction in the rate of treatment failure within the ITT set at Day 57 by at least 50% in response to SHB004 (10% topical azithromycin) administered locally within four calendar days after the tick bite had been first noticed, BID for three consecutive days, as compared to placebo. Treatment failure is defined as seroconversion (IgM and / or IgG) and / or appearance of EM throughout the study in baseline-seronegative (IgM and / or IgG) subjects. Subjects experiencing an additional tick bite are not counted as treatment failure unless they experience an EM occurring before the additional tick bite.;Secondary Objective: Secondary objective 1 is as the primary objective for the All Treated Subjects A-C set, and modified ITT set. Secondary objective 2 is as the primary objective in the ITT set and isolated IgM are not counted as Treatment Failure (TF). Secondary objective 3 is as the primary objective in the ITT set and isolated IgG are not counted as TF. Exploratory objective is as the primary objective but for the PP set. Safety: To demonstrate the local safety and tolerability of SHB004 (10% topical azithromycin) administered locally BID for three consecutive days.;Primary end point(s): treatment failure within the ITT set at Day 57;;Timepoint(s) of evaluation of this end point: Visit 4; Day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective 1 is as the primary objective for the All Treated Subjects A-C set, and modified ITT set. Secondary objective 2 is as the primary objective in the ITT set and isolated IgM are not counted as Treatment Failure (TF). Secondary objective 3 is as the primary objective in the ITT set and isolated IgG are not counted as TF. Exploratory objective is as the primary objective but for the PP set.;Timepoint(s) of evaluation of this end point: Visit 4; Day 57 | — |
Countries
Austria, Germany
Contacts
Public ContactAnke Rodenberg
PAREXEL International GmbH
Outcome results
None listed