Onchocerciasis
Conditions
Interventions
Part 0 emodepside 15mg OD 1 day
Part 1 emodepside 30mg OD 1 day
Part 1 emodepside 15mg OD 7 days
Part 1 emodepside 15mg OD 14 days
Part 1 emodepside 15mg BID 10 days
Part 2 emodepside regimen A
Part 2 emodepside regimen B
Part 2 ivermectin
Sponsors
Drugs for Neglected Diseases Initiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria 1. Written, signed (or thumb-printed) and dated informed consent 2. Men and women 18 to 65 years of age with Onchocerca volvulus infection a. Presence of at least 1 excisable subcutaneous nodule/onchocercoma detected on palpation b. O. volvulus infection diagnosed by skin snip method, documented skin assessment on 4 skin snips. c. Body weight at Screening > 40 kg 3. For women of child-bearing potential (WOCBP), acceptance of the requirement to use a highly effective form of birth control
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria 1. Administration of medication or herbal therapies as follows: i. The following antifilarial therapies or medication that may have an antifilarial effect: • ivermectin, = 6 months prior to IMP administration, and / or • doxycycline, = 1 year prior to IMP administration, more than 2 weeks course, and / or • moxidectin, = 2 years prior to IMP administration. ii. Other preventive chemotherapy, e.g. as part of an MDA programme within 14 days prior to IMP administration. 2. Presence of any clinically significant medical condition at Screening: including, but not limited to diabetes type 1 or 2; past or current history of neurological or neuropsychiatric disease or epilepsy; sickle cell disease; known human immunodeficiency virus (HIV) infection, disclosed by review of medical history or concomitant medication. 3. Presence of abnormal physical findings or laboratory values at Screening that could interfere with the objectives of the trial or the safety of the subject, in the opinion of the Investigator. 4. Known hypersensitivity to any ingredient of the IMP, including the active ingredient emodepside, or to ivermectin, or to any medication used during the study. 5. Current hyperreactive onchodermatitis or severe manifestations due to onchocerciasis. 6. Coincidental infection with other endemic filarial parasites based on laboratory tests at Screening (Wuchereria bancrofti, Mansonella spp.). 7. Coincidental infection with Loa loa based on medical history or positive test at Screening. 8. In groups intended to include subjects without ocular involvement: ocular microfilariae or onchocercal eye lesions, assessed at Screening. 9. Ophthalmological history or conditions that could make the ocular examination difficult or represent a risk for the safety of the subject. 10. For WOCBP: Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1. Absence of live female adult worms with normal embryogenesis, assessed by histological examination of nodules collected on nodulectomy at Month 12.;Part 1. Co-primary outcome. Absence of skin microfilariae across four skin snips sampled at Month 12.;Part 2. Percentage of subjects without skin microfilariae at Month 24, assessed across all skin snips in a subject.;Part 0. Safety and tolerability of emodepside in O. volvulus infected subjects, as measured by adverse event assessment, physical examination, skin examination, neurological examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests, and ophthalmological examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1. The percentage of subjects with live female adult worms (assessed by histological examination of nodules collected after nodulectomy at Month 12);Part 1. The percentage of subjects with dead female adult worms (assessed by histological examination of nodules collected after nodulectomy at Month 12);Part 1. The percentage of subjects without skin microfilariae at all time-points after treatment.;Part 1. The reduction in skin microfilarial density, defined as the mean number of mf/mg per subject, at all time-points after treatment related to baseline: change and percentage reduction at all time-points after treatment;;Part 1. The presence of microfilariae in nodular tissue assessed by histological examination of nodules collected after nodulectomy at Month 12.;Part 2. The percentage of subjects without live female adult worms with normal embryogenesis (assessed by histological examination of nodules collected after nodulectomy at Month 24);Part 2. The percentage of subjects with live female adult worms (assessed by histological examination of nodules collected after nodulectomy at Month 24);Part 2. The percentage of subjects with dead female adult worms (assessed by histological examination of nodules collected after nodulectomy at Month 24);Part 2. The percentage of subjects with live female adult worms with normal embryogenesis (assessed by histological examination of nodules collected after nodulectomy at Month 24);Part 2. The percentage of subjects without skin microfilariae at all time-points after treatment;Part 2. The reduction in skin microfilarial density, defined as the mean number of mf/mg per subject, at all time-points after treatment related to baseline: change and percentage reduction at all time-points after treatment.;Part 2. The presence of microfilariae in nodular tissue, assessed by histological examination of nodules collected on nodulectomy at Month 24.;Safety and Tolerability Outcome - Parts 1 and 2 - Safety and tolerability of emodepsid | — |
Countries
Congo, Ghana
Contacts
Public ContactVirginie Pillet
DNDi Senior Clinical Project Manager
Outcome results
None listed