Study to Assess Adverse Events, Change in Disease Activit... | NCT04913610

ID	Type	Description	Link
DNDi-TYL-01	Other Identifier	DNDi

Status Module

Name	Class
Drugs for Neglected Diseases	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.	Drug: ABBV-4083 Drug: Placebo for ABBV-4083 Drug: Placebo for Albendazole
Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.	Drug: ABBV-4083 Drug: Placebo for Albendazole
Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.	Drug: ABBV-4083 Drug: Placebo for ABBV-4083 Drug: Albendazole
Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 3 days followed by ABBV-4083 400 mg and placebo capsules for albendazole for 4 days followed by placebo capsules for ABBV-4083 for 7 days.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABBV-4083	Drug	Oral Capsule	Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days

Measure	Description	Time Frame
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.	At Month 6

Measure	Description	Time Frame
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.	At Month 6
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Onchocerca volvulus infection at time of Screening:
- Presence of at least one excisable subcutaneous nodule/ onchocercoma detected on palpation;
- O. volvulus infection diagnosed by skin snip method: documented mfpositivity on skin assessment on at least 2 out of 4 skin snips.
Body weight > 40 kg at Screening.
For women of child-bearing potential, acceptance of the requirement to use a highly effective form of birth control from Day 0 until at least 1 month after the final intake of study drug (Part 1: day 43; Part 2: 1 month after the administration of ivermectin or matching placebo at the Month 6 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 trial, or within 5 times the half-life of the drug tested in the previous clinical trial or is currently in the follow-up period for any clinical trial.
Any vaccination within 4 weeks prior to investigational medicinal product (IMP) administration.
Acute infection and/or febrile illness requiring therapy within 14 days prior to IMP administration.
Administration of medication or herbal preparations as follows:
- Administration of any medication (with the exception of diclofenac, paracetamol, ibuprofen and aspirin) or herbal preparation within 14 days prior to IMP administration;
- Use of strong CYP3A inhibitors or inducers including but not limited to ritonavir, ketoconazole, rifampicin, phenytoin, phenobarbital, carbamazepine, cimetidine within 14 days or 10 half-lives, whichever is longer, prior to IMP administration;
- Use of other drugs known to interact with albendazole i.e. praziquantel, theophylline or dexamethasone, within 14 days or 10 half-lives, whichever is longer, prior to IMP administration;
- Antifilarial therapies, or medication that may have an antifilarial effect.
Requirement for and inability to avoid ivermectin during the first 6 months after IMP administration. Requirement for albendazole during the first 28 days after IMP administration or more than one dose per year thereafter given in MDA.
Presence of any of the following at Screening, that could interfere with the objectives of the trial or the safety of the participant, in the opinion of the Investigator:
- Clinically significant abnormal physical and/or neurological examination or laboratory findings;
- Any clinically significant medical condition. Including, but not limited to significant acute or chronic liver or kidney condition or cardiovascular disease, active infection, current or previous epilepsy, known human immunodeficiency virus infection, disclosed by review of medical history or concomitant medication.
Ophthalmological history or conditions that could interfere with the objectives of the trial or compromise the safety of the subject in the opinion of the Investigator, assessed at Screening.
History of drug or alcohol abuse within 6 months prior to IMP administration.
Use of alcohol within 48 hours and/or use of drugs of abuse within 15 days before IMP administration.
Clinically significant history of cardiac abnormality, and/or relevant pathological abnormalities in the ECG in the screening period.
Abnormal laboratory test results at Screening.
History of severe drug allergy, non-allergic drug reactions, severe adverse reaction to any drug, or multiple drug allergies.
Known hypersensitivity to any ingredient of the IMPs, including the active ingredient of ABBV-4083, macrolides, albendazole or to ivermectin or to any medication used during the study.
Blood donation within 8 weeks prior to Screening or blood transfusion received within 1 year prior to Screening.
Coincidental infection with high Loa loa load at Screening.
Current hyperreactive onchodermatitis or severe manifestation due to onchocerciasis.
Any other past or current condition that the Investigator feels would exclude the participant from the study or place the subject at undue risk.
For women of child-bearing potential: pregnant, based on date of last menstrual period, and pregnancy test prior to first intake of IMP, or breastfeeding.
Unwilling or unable to comply with the requirements of the study protocol for the entire duration of the study, in the opinion of the Investigator.
Unable to participate in the study as per local law, if applicable.

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Général de Référence de Kimpese		Kimpese	Bas-Congo Province		Democratic Republic of the Congo

ID	Title	Description
FG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
FG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 9, 2021	Aug 19, 2024

Arm/Group Information

ID	Title	Description
BG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
BG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
BG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
BG003	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 3 days followed by ABBV-4083 400 mg and placebo capsules for albendazole for 4 days followed by placebo capsules for ABBV-4083 for 7 days.
BG004	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received placebo for ABBV-4083 administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00031 BG00131 BG00229 BG00329 BG00431 BG005151

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG00229 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Ethnicity (NIH/OMB)

Ethnicity was not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Body weight

Mean

Standard Deviation

kilograms

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Number of operable sites with onchocercomata

Mean

Standard Deviation

sites

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Number of palpated onchocerca nodules

Mean

Standard Deviation

nodules

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Skin microfilarial density

Mean

Standard Deviation

mf/mg of skin

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Number of previous ivermectin rounds

Mean

Standard Deviation

rounds

Title	Denominators	Categories
	ParticipantsBG00031 ParticipantsBG00131 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Per protocol population: all ITT participants who had nodulectomy at Month 6 (ND6M) with live female adult worms, who completed treatment, and who did not take prohibited medication(s) during the study

Posted

Number

95% Confidence Interval

Percentage of worms without Wolbachia

At Month 6

Live female adult worms with data

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG003	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 3 days followed by ABBV-4083 400 mg and placebo capsules for albendazole for 4 days followed by placebo capsules for ABBV-4083 for 7 days.
OG004	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received placebo for ABBV-4083 administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0006.0(2.6 to 13.2) OG0012.3(0.6 to 8.0) OG0020.0(0.0 to 4.5) OG003

Secondary

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.

Intention-to-treat (ITT) population who had live female adult worms that contained either normal embryos, degenerated embryos, or both

Posted

Mean

Standard Deviation

Percentage of worms per participant

At Month 6

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had female adult worms

Posted

Mean

Standard Deviation

Percentage of worms per participant

At Month 6

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had post-baseline values at Month 6

Posted

Number

Percentage of participants

At Month 6

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had post-baseline values at Month 3

Posted

Number

Percentage of participants

At Month 3

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had post-baseline values at Month 6

Posted

Number

Percentage of participants

At Month 6

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had values at Baseline and Month 3

Posted

Mean

Standard Deviation

Mean number of microfilariae/mg of skin

Baseline, Month 3

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had values at Baseline and Month 6

Posted

Mean

Standard Deviation

Mean number of microfilariae/mg of skin

Baseline, Month 6

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Secondary

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.

Intention-to-treat (ITT) population who had live female adult worms

Posted

Number

Percentage of nodules

At Month 6

Nodules w/live female adult worms + data

ID	Title	Description
OG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.
OG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.
OG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	Participants randomized to receive ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days.	31	0	31	14	31
EG001	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	Participants randomized to receive ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days.	31	2	31	9	31
EG002	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	Participants randomized to receive ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.	30	2	30	13	30
EG003	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)	Participants randomized to receive ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 3 days followed by ABBV-4083 400 mg and placebo capsules for albendazole for 4 days followed by placebo capsules for ABBV-4083 for 7 days.	30	0	30	10	30
EG004	Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D)	All participants who were randomized to receive ABBV-4083	122	4	122	46	122
EG005	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)	Participants randomized to receive placebo for ABBV-4083 administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days.	31	4	31	14	31

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG0030 events0 affected30 at risk EG0040 events0 affected122 at risk EG0051 events1 affected31 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
RETINAL HAEMORRHAGE	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected30 at risk EG003
PERIODONTITIS	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected30 at risk EG003
ABDOMINAL INJURY	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
ELECTROCARDIOGRAM T WAVE INVERSION	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
NASAL POLYPS	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
EOSINOPHILIA	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected30 at risk EG0032 events2 affected30 at risk EG0045 events5 affected122 at risk EG0052 events2 affected31 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected31 at risk EG0012 events2 affected31 at risk EG0027 events7 affected30 at risk EG003
EYE PRURITUS	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
VISUAL FIELD DEFECT	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected31 at risk EG0012 events2 affected31 at risk EG0021 events1 affected30 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected30 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected30 at risk EG003
MALARIA	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected31 at risk EG0023 events3 affected30 at risk EG003
SCHISTOSOMIASIS BLADDER	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected31 at risk EG0022 events2 affected30 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected30 at risk EG003

ID	Term
D009855	Onchocerciasis
D015827	Onchocerciasis, Ocular

ID	Term
D005368	Filariasis
D017205	Spirurida Infections
D017190	Secernentea Infections
D009349	Nematode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections
D012876	Skin Diseases, Parasitic
D012874	Skin Diseases, Infectious
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D015822	Eye Infections, Parasitic
D000079426	Vector Borne Diseases
D015817	Eye Infections
D005128	Eye Diseases

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds