Emodepside phase II trial for treatment of onchocerciasis

Phase 2

Recruiting

• Conditions: Onchocerciasis

• Registration Number: PACTR202010898529928
• Lead Sponsor: Drugs for Neglected Diseases Initiative

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 578

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified