Emodepside Phase II Trial for Treatment of Onchocerciasis (NCT05180461) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Emodepside Phase II Trial for Treatment of Onchocerciasis
Democratic Republic of the Congo, Ghana578 participantsStarted 2021-08-30
Plain-language summary
The trial evaluates safety, tolerability, pharmacodynamics, pharmacokinetics, dose-response, and efficacy of emodepside tablets, administrated as a range of dose regimens, in adults infected with Onchocerca Volvulus.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Written, signed (or thumb-printed) and dated informed consent, after having the opportunity to discuss the study with the Investigator or a delegate.
✓. Men and women with Onchocerca volvulus infection, 18 to 65 years of age inclusive at time of Screening,
✓. Presence of at least 1 excisable subcutaneous nodule/onchocercoma detected on palpation
✓. O. volvulus infection diagnosed by skin snip method: documented mf-positivity on skin assessment on at least 2 out of 4 skin snips.
✓. Body weight at Screening ≥ 40 kg
✓. For women of child-bearing potential, acceptance of the requirement to use a highly effective form of birth control effective from Day 0 until at least 3 months after the final intake of IMP (Month 4 visit). Choice of birth control method must be clearly documented.
Exclusion criteria
✕. Participation in any studies other than purely observational studies within 3 months prior to Screening or during the study, or within 5 times the half-life of the drug in the previous clinical trial, whichever is longer (time calculated relative to final intake in previous trial) or currently in the follow-up period for any clinical trial.
✕. Any vaccination within 4 weeks prior to IMP administration.
✕. Acute infection and/or febrile illness requiring therapy within 14 days prior to IMP administration.
✕. Administration of medication or herbal therapies as follows:
What they're measuring
1
Part 1 - absence (or presence) of live female adult worms with normal embryogenesis
Timeframe: 12 months
2
Part 1 - absence (or presence) of skin microfilariae (co-primary outcome)
Timeframe: 12 months
3
Part 2 - absence (or presence) of skin microfilariae
. Administration of any medication (with the exception of diclofenac, paracetamol, ibuprofen and aspirin) or herbal preparation within 14 days prior to IMP administration, or medicine given regularly for an existing condition;
✕. The following antifilarial therapies, or medication that may have an antifilarial effect:
✕. Other preventive chemotherapy, e.g. as part of an MDA programme within 14 days prior to IMP administration.
✕. 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.