E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Scabies (infection with Sarcoptes scabiei) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039511 |
E.1.2 | Term | Scabies |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objectives of the trial are to identify an optimal dose of moxidectin for the treatment of scabies and evaluate the safety of moxidectin in adults infected with scabies |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the trial is to characterize the plasma pharmacokinetics of moxidectin in adults infected with scabies. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged ≥ 18 years. 2. Provision of written informed consent. 3. Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the presence of at least two lesions (which may include burrows), each containing at least one live (internal and/or external structures discernable) adult Sarcoptes scabiei mite observed by Reflectance Confocal Microscopy (RCM). 4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening until 6 months after treatment with study drug.
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E.4 | Principal exclusion criteria |
1. History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies. 2. Diagnosis of crusted/Norwegian scabies or scabies that, in the opinion of the Investigator, would require treatment with more than one standard of care (e.g. scabies requiring concurrent topical and oral treatment. 3. Received any treatment for scabies within 7 days of Screening, including but not limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion, and/or tea tree oil. 4. Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that would put the subject at increased risk from participating in the study or confound study evaluations. 5. Poor venous access. 6. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer). 7. Body Mass Index over 35 kg/m2 8. Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator. 9. Clinically relevant laboratory abnormalities at Screening, including: a. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range; b. creatinine > 2.0 milligrams per deciliter (mg/dL); c. hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male); d. amylase > 2.0 x upper limit of reference range. 10. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin. 11. Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7 out of the 14 days prior to Screening. 12. Subjects with known or suspected Loa loa coinfection. 13. Difficulty swallowing tablets. 14. Pregnant or breastfeeding, or planning to become pregnant. 15. Known or suspected alcohol or illicit substance abuse. 16. Unwilling, unlikely or unable to comply with all protocol specified assessments. 17. Previous enrolment and treatment with moxidectin in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be determined by death of the mites, defined as the degradation (loss of internal and/or external anatomic structures) of the adult mite observed by reflectance confocal microscopy (RCM). Safety will be assessed by the incidence and severity of adverse event (AEs), physical examinations, measurement of vital signs and laboratory safety parameters. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Efficacy as determined by observation with RCM will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28 in not less than two lesions nominated pre-treatment. Safety (incidence and severity of adverse events, physical examinations and measurement of vital signs) will be assessed up to and including Week 12, and laboratory safety parameters up to and including Day 28. |
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E.5.2 | Secondary end point(s) |
Key exposure metrics for moxidectin including area under the concentration time curve (AUC) and maximum plasma concentration (Cmax), will be determined by non-compartmental analysis of moxidectin pharmacokinetic parameters or other methods as appropriate. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The plasma concentration of moxidectin will be assessed at Hours 4, 8, 24, 48 and 72 and Days 7, 14 and 28. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
2 mg, 8 mg, 20 mg moxidectin will be evaluated. A fourth dose, of 36 mg, may be added |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |