Clinical trial NCT03876262: Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Official title: A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Onchocerciasis
Lead sponsor: Medicines Development for Global Health
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 323
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
Primary purpose: TREATMENT

Brief summary: The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness.

Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent, or assent with parental or guardian written consent.
* Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
* Living in a village selected for the study.
* Age ≥ 12 years.
* All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
* Has received ivermectin, oral diethylcarbamazine (DEC) or doxycycline (for \> 2 weeks) within 6 months of Baseline.
* Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
* Known or suspected allergy to ivermectin or moxidectin or their excipients.
* Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
* Weight \> 88 kg.
* Infection with Loa loa.

Primary outcomes:
measure: Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
timeFrame: Up to 12 months
measure: Incidence and severity of adverse events
timeFrame: Up to 36 months
Secondary outcomes:
measure: Proportion of participants in all dose groups with sustained microfilariae response
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
measure: Sustained ocular microfilariae response in all dose groups
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
measure: Skin microfilarial density in all dose groups
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
measure: Ocular microfilariae response in all dose groups
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
measure: Mean skin microfilariae density at each post-Screening assessment
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Other outcomes:
measure: Signs and symptoms of onchocerciasis in all dose groups
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
measure: Viability and fertility of male and female macrofilariae in all dose groups
timeFrame: 36 months
Locations:
city: Rethy
country: Congo, The Democratic Republic of the
facility: Centre de Recherche pour les Maladies Tropicales Negligees
state: Ituri
Study officials:
affiliation: Centre de Recherche en Maladies Tropicales de l'Ituri
name: Tony Ukety, MD, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: