Onchocerciasis is a major public health problem in affected countries that causes disease-induced disability, and overall loss of economic productivity. The purpose of this study is to determine how safe and effective ABBV-4083 in combination with albendazole is in treating participants with Onchocerciasis. ABBV-4083 is an investigational drug being developed for the treatment of onchocerciasis. This study is conducted in 2 parts. In part 1, participants are randomly assigned to 1 of 5 groups, called treatment arms to determine the most efficient treatment combination. Each group receives a different treatment. In part 2, participants are randomly assigned to 1 of 4 treatment arms. Approximately 444 or 486 adult participants with a diagnosis of onchocerciasis will be enrolled in approximately 2 sites in Democratic Republic of Congo. Participants in Part 1 will receive different treatment combinations of ABBV-4083 and/or albendazole and/or matching placebo capsules for 14 days. Participants in Part 2 will receive the most effective treatment combination(s) determined in Part 1 for 14 days followed by ivermectin or matching placebo capsules at Month 6; duration of treatment is 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
The study was terminated at the conclusion of Part 1, and Part 2 of the study was not conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Hôpital Général de Référence de Kimpese
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
Hôpital Général de Référence de Masi-Manimba
Masi-Manimba, Kwilu, Democratic Republic of the Congo
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules
The Wolbachia endobacteria status of each live female adult worm was determined by immunohistology of nodules collected after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6
The percentage of live female adult worms with only degenerated embryos in the uterus per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6
The percentage of live female adult worms out of all female adult worms per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6
The absence of microfilariae in nodular tissue per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Participants Without Skin Microfilariae at Month 3
The presence or absence of microfilariae in skin was determined at the Month 3 visit.
Time frame: At Month 3
Part 1: Percentage of Participants Without Skin Microfilariae at Month 6
The presence or absence of microfilariae in skin was determined at the Month 6 visit.
Time frame: At Month 6
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3
Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.
Time frame: Baseline, Month 3
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6
Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.
Time frame: Baseline, Month 6
Part 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6
The Wolbachia endobacteria status of each live female adult worm was determined by PCR of nodules collected after nodulectomy at the Month 6 visit.
Time frame: At Month 6
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