Trial Outcomes & Findings for Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection (NCT NCT04913610)

Last Updated: 2024-09-19

Results Overview

The Wolbachia endobacteria status of each live female adult worm was determined by immunohistology of nodules collected after nodulectomy at the Month 6 visit.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

153 participants

Primary outcome timeframe

At Month 6

Results posted on

2024-09-19

Participant Flow

A total of 153 participants were randomized, of which 151 received study drug (Intention-to-Treat, ITT; Safety population).

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Randomized Participants STARTED	31	31	30	30	31
Randomized Participants COMPLETED	31	31	29	29	31
Randomized Participants NOT COMPLETED	0	0	1	1	0
Treated (ITT & Safety Population) STARTED	31	31	29	29	31
Treated (ITT & Safety Population) COMPLETED	30	31	29	29	30
Treated (ITT & Safety Population) NOT COMPLETED	1	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Randomized Participants Did Not Receive Treatment	0	0	1	1	0
Treated (ITT & Safety Population) Lost to Follow-up	1	0	0	0	1

Baseline Characteristics

Ethnicity was not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=29 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=29 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=31 Participants 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.	Total n=151 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 11.73 • n=31 Participants	40.1 years STANDARD_DEVIATION 12.08 • n=29 Participants	38.7 years STANDARD_DEVIATION 10.78 • n=29 Participants	43.6 years STANDARD_DEVIATION 10.36 • n=31 Participants	38.5 years STANDARD_DEVIATION 12.34 • n=31 Participants	39.6 years STANDARD_DEVIATION 11.55 • n=151 Participants
Sex: Female, Male Female	4 Participants n=31 Participants	0 Participants n=29 Participants	4 Participants n=29 Participants	2 Participants n=31 Participants	6 Participants n=31 Participants	16 Participants n=151 Participants
Sex: Female, Male Male	27 Participants n=31 Participants	29 Participants n=29 Participants	25 Participants n=29 Participants	29 Participants n=31 Participants	25 Participants n=31 Participants	135 Participants n=151 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	—	—	—	0 Participants Ethnicity was not collected from any participant.
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	—	—	—	0 Participants Ethnicity was not collected from any participant.
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	—	—	—	0 Participants Ethnicity was not collected from any participant.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Black or African American	31 Participants n=31 Participants	29 Participants n=29 Participants	29 Participants n=29 Participants	31 Participants n=31 Participants	31 Participants n=31 Participants	151 Participants n=151 Participants
Race (NIH/OMB) White	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=151 Participants
Body weight	50.98 kilograms STANDARD_DEVIATION 6.04 • n=31 Participants	53.48 kilograms STANDARD_DEVIATION 7.12 • n=29 Participants	52.38 kilograms STANDARD_DEVIATION 6.42 • n=29 Participants	53.55 kilograms STANDARD_DEVIATION 7.03 • n=31 Participants	49.77 kilograms STANDARD_DEVIATION 6.96 • n=31 Participants	52.01 kilograms STANDARD_DEVIATION 6.80 • n=151 Participants
Number of operable sites with onchocercomata	1.6 sites STANDARD_DEVIATION 0.67 • n=31 Participants	1.6 sites STANDARD_DEVIATION 0.74 • n=29 Participants	1.6 sites STANDARD_DEVIATION 1.02 • n=29 Participants	1.5 sites STANDARD_DEVIATION 0.72 • n=31 Participants	1.5 sites STANDARD_DEVIATION 0.68 • n=31 Participants	1.5 sites STANDARD_DEVIATION 0.76 • n=151 Participants
Number of palpated onchocerca nodules	1.7 nodules STANDARD_DEVIATION 0.70 • n=31 Participants	1.7 nodules STANDARD_DEVIATION 1.03 • n=29 Participants	1.8 nodules STANDARD_DEVIATION 1.15 • n=29 Participants	1.7 nodules STANDARD_DEVIATION 0.83 • n=31 Participants	1.7 nodules STANDARD_DEVIATION 0.93 • n=31 Participants	1.7 nodules STANDARD_DEVIATION 0.92 • n=151 Participants
Skin microfilarial density	26.55 mf/mg of skin STANDARD_DEVIATION 33.06 • n=31 Participants	20.60 mf/mg of skin STANDARD_DEVIATION 35.52 • n=29 Participants	19.45 mf/mg of skin STANDARD_DEVIATION 34.97 • n=29 Participants	8.22 mf/mg of skin STANDARD_DEVIATION 12.25 • n=31 Participants	16.59 mf/mg of skin STANDARD_DEVIATION 25.81 • n=31 Participants	18.23 mf/mg of skin STANDARD_DEVIATION 29.71 • n=151 Participants
Number of previous ivermectin rounds	0.0 rounds STANDARD_DEVIATION 0.18 • n=31 Participants	0.4 rounds STANDARD_DEVIATION 0.87 • n=29 Participants	0.3 rounds STANDARD_DEVIATION 0.59 • n=29 Participants	0.4 rounds STANDARD_DEVIATION 0.71 • n=31 Participants	0.2 rounds STANDARD_DEVIATION 0.67 • n=31 Participants	0.3 rounds STANDARD_DEVIATION 0.65 • n=151 Participants

PRIMARY outcome

Timeframe: At Month 6

Population: 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

The Wolbachia endobacteria status of each live female adult worm was determined by immunohistology of nodules collected after nodulectomy at the Month 6 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=84 Live female adult worms with data 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=87 Live female adult worms with data 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=82 Live female adult worms with data 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=90 Live female adult worms with data 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=77 Live female adult worms with data 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.
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	6.0 Percentage of worms without Wolbachia Interval 2.6 to 13.2	2.3 Percentage of worms without Wolbachia Interval 0.6 to 8.0	0.0 Percentage of worms without Wolbachia Interval 0.0 to 4.5	0.0 Percentage of worms without Wolbachia Interval 0.0 to 4.1	2.6 Percentage of worms without Wolbachia Interval 0.7 to 9.0

SECONDARY outcome

Timeframe: At Month 6

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

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.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=19 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=20 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=19 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=18 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=16 Participants 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.
Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6	0.48 Percentage of worms per participant Standard Deviation 2.086	7.67 Percentage of worms per participant Standard Deviation 18.420	9.82 Percentage of worms per participant Standard Deviation 19.578	7.59 Percentage of worms per participant Standard Deviation 23.813	10.16 Percentage of worms per participant Standard Deviation 18.064

SECONDARY outcome

Timeframe: At Month 6

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

The percentage of live female adult worms out of all female adult worms per participant was determined after nodulectomy at the Month 6 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=22 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=26 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=24 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=22 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=22 Participants 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.
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6	84.27 Percentage of worms per participant Standard Deviation 19.904	77.74 Percentage of worms per participant Standard Deviation 32.445	78.03 Percentage of worms per participant Standard Deviation 29.811	79.37 Percentage of worms per participant Standard Deviation 27.013	79.52 Percentage of worms per participant Standard Deviation 30.496

SECONDARY outcome

Timeframe: At Month 6

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

The absence of microfilariae in nodular tissue per participant was determined after nodulectomy at the Month 6 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=22 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=26 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=24 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=22 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=23 Participants 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.
Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6	22.7 Percentage of participants	26.9 Percentage of participants	41.7 Percentage of participants	31.8 Percentage of participants	30.4 Percentage of participants

SECONDARY outcome

Timeframe: At Month 3

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

The presence or absence of microfilariae in skin was determined at the Month 3 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=28 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=30 Participants 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.
Part 1: Percentage of Participants Without Skin Microfilariae at Month 3	3.2 Percentage of participants	3.2 Percentage of participants	3.6 Percentage of participants	3.6 Percentage of participants	3.3 Percentage of participants

SECONDARY outcome

Timeframe: At Month 6

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

The presence or absence of microfilariae in skin was determined at the Month 6 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=27 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=28 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=25 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.
Part 1: Percentage of Participants Without Skin Microfilariae at Month 6	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	7.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3

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

Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=31 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=28 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=30 Participants 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.
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3	-0.44 Mean number of microfilariae/mg of skin Standard Deviation 5.576	-7.99 Mean number of microfilariae/mg of skin Standard Deviation 16.180	2.43 Mean number of microfilariae/mg of skin Standard Deviation 13.148	1.36 Mean number of microfilariae/mg of skin Standard Deviation 12.189	-1.03 Mean number of microfilariae/mg of skin Standard Deviation 10.787

SECONDARY outcome

Timeframe: Baseline, Month 6

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

Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=27 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=28 Participants 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=25 Participants 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=28 Participants 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.
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6	-0.19 Mean number of microfilariae/mg of skin Standard Deviation 6.330	5.55 Mean number of microfilariae/mg of skin Standard Deviation 24.293	-1.19 Mean number of microfilariae/mg of skin Standard Deviation 32.856	-2.72 Mean number of microfilariae/mg of skin Standard Deviation 19.769	-1.67 Mean number of microfilariae/mg of skin Standard Deviation 14.223

SECONDARY outcome

Timeframe: At Month 6

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

The Wolbachia endobacteria status of each live female adult worm was determined by PCR of nodules collected after nodulectomy at the Month 6 visit.

Outcome measures

Outcome measures
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n=26 Nodules w/live female adult worms + data 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n=32 Nodules w/live female adult worms + data 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=21 Nodules w/live female adult worms + data 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n=32 Nodules w/live female adult worms + data 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.	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n=17 Nodules w/live female adult worms + data 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.
Part 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6	0 Percentage of nodules	0 Percentage of nodules	0 Percentage of nodules	0 Percentage of nodules	0 Percentage of nodules

Adverse Events

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D)

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A) n=31 participants at risk 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B) n=31 participants at risk 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C) n=30 participants at risk 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D) n=30 participants at risk 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.	Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D) n=122 participants at risk All participants who were randomized to receive ABBV-4083	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E) n=31 participants at risk 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.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Eye disorders RETINAL HAEMORRHAGE	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Eye disorders RETINAL VEIN OCCLUSION	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Infections and infestations APPENDICITIS	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Infections and infestations PERIODONTITIS	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Injury, poisoning and procedural complications ABDOMINAL INJURY	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Investigations ELECTROCARDIOGRAM T WAVE INVERSION	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.

Other adverse events

Other adverse events
Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A) n=31 participants at risk 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.	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B) n=31 participants at risk 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.	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C) n=30 participants at risk 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.	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D) n=30 participants at risk 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.	Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D) n=122 participants at risk All participants who were randomized to receive ABBV-4083	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E) n=31 participants at risk 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.
Blood and lymphatic system disorders EOSINOPHILIA	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	4.1% 5/122 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Blood and lymphatic system disorders NEUTROPENIA	16.1% 5/31 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	23.3% 7/30 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	13.1% 16/122 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Eye disorders EYE PRURITUS	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.82% 1/122 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Eye disorders VISUAL FIELD DEFECT	9.7% 3/31 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	4.9% 6/122 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 4/122 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	2.5% 3/122 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Infections and infestations MALARIA	9.7% 3/31 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	7.4% 9/122 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	19.4% 6/31 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Infections and infestations SCHISTOSOMIASIS BLADDER	9.7% 3/31 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	5.7% 7/122 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	1.6% 2/122 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/122 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.
Nervous system disorders HEADACHE	3.2% 1/31 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	6.5% 2/31 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	2.5% 3/122 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.	0.00% 0/31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 201 days for Arms A, B, C, and all participants randomized to receive ABBV-4083; 210 days for Arm D; and 213 days for Arm E.

Additional Information

Clinical Trial Data

Drugs for Neglected Diseases initiative

Phone: 41 22 906 9230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A multisite publication of the results is made prior to any publication based on results obtained by a specific site. Written publications or oral presentations that include all or part of the results must be sent to DNDi for review and comment at least 28 days prior to the planned date of publication/presentation. In addition, publication/presentation of results will be delayed for a further 90 days in the event that DNDi wishes to protect the results by patent application or other means.
Publication restrictions are in place

Restriction type: OTHER