TerminatedNCT04913610Updated Sep 19, 2024Results posted

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

A Phase 2 interventional study of ABBV-4083 and Placebo for ABBV-4083 in Onchocerciasis, sponsored by AbbVie. Terminated at 2 sites in Congo, The Democratic Republic of the. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Why this study was terminated

Strategic considerations

Phase: Phase 2
Study type: Interventional
Enrollment: 153
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Onchocerciasis is a major public health problem in affected countries that causes disease-induced disability, and overall loss of economic productivity. The purpose of this study is to determine how safe and effective ABBV-4083 in combination with albendazole is in treating participants with Onchocerciasis.

ABBV-4083 is an investigational drug being developed for the treatment of onchocerciasis. This study is conducted in 2 parts. In part 1, participants are randomly assigned to 1 of 5 groups, called treatment arms to determine the most efficient treatment combination. Each group receives a different treatment. In part 2, participants are randomly assigned to 1 of 4 treatment arms. Approximately 444 or 486 adult participants with a diagnosis of onchocerciasis will be enrolled in approximately 2 sites in Democratic Republic of Congo.

Participants in Part 1 will receive different treatment combinations of ABBV-4083 and/or albendazole and/or matching placebo capsules for 14 days. Participants in Part 2 will receive the most effective treatment combination(s) determined in Part 1 for 14 days followed by ivermectin or matching placebo capsules at Month 6; duration of treatment is 24 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

Read the detailed description

The study was terminated at the conclusion of Part 1, and Part 2 of the study was not conducted.

Conditions studied

Onchocerciasis

Browse trials for

Onchocerciasis 35

Keywords

Onchocerciasis
Onchocerca volvulus
River blindness
ABBV-4083
Tylamac

In context

Onchocerciasis

35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.

This study's enrollment of 153 is below the median of 216 across 26 interventional studies indexed under Onchocerciasis.

Browse Onchocerciasis studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Browse AbbVie studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , acceptance of the requirement to use a highly effective form of 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

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 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 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:
- 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 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 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 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 : 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.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 153 participants (actual)

Study arms

Experimental
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.
Drug: ABBV-4083 · Drug: Placebo for ABBV-4083 · Drug: Placebo for Albendazole
Experimental
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.
Drug: ABBV-4083 · Drug: Placebo for Albendazole
Experimental
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.
Drug: ABBV-4083 · Drug: Placebo for ABBV-4083 · Drug: Albendazole
Experimental
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.
Drug: ABBV-4083 · Drug: Placebo for ABBV-4083 · Drug: Albendazole · Drug: Placebo for Albendazole
Experimental
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.
Drug: Placebo for ABBV-4083 · Drug: Albendazole

Interventions

DrugABBV-4083
Oral Capsule
Also known as: Tylamac
DrugPlacebo for ABBV-4083
Oral Capsule
DrugAlbendazole
Oral encapsulated tablets
Also known as: Zentel
DrugPlacebo for Albendazole
Oral Capsule

What researchers measure

Primary outcomes

Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules
The Wolbachia endobacteria status of each live female adult worm was determined by immunohistology of nodules collected after nodulectomy at the Month 6 visit.
Time frame: At Month 6

Secondary outcomes

Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6
The percentage of live female adult worms with only degenerated embryos in the uterus per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6
The percentage of live female adult worms out of all female adult worms per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6
The absence of microfilariae in nodular tissue per participant was determined after nodulectomy at the Month 6 visit.
Time frame: At Month 6
Part 1: Percentage of Participants Without Skin Microfilariae at Month 3
The presence or absence of microfilariae in skin was determined at the Month 3 visit.
Time frame: At Month 3
Part 1: Percentage of Participants Without Skin Microfilariae at Month 6
The presence or absence of microfilariae in skin was determined at the Month 6 visit.
Time frame: At Month 6
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3
Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.
Time frame: Baseline, Month 3
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6
Skin microfilarial density is defined as the mean number of microfilariae/mg of skin per participant.
Time frame: Baseline, Month 6
Part 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6
The Wolbachia endobacteria status of each live female adult worm was determined by PCR of nodules collected after nodulectomy at the Month 6 visit.
Time frame: At Month 6

Results

Posted Sep 19, 2024

Participant flow

Randomized Participants

Participant flow — Randomized Participants
Milestone	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Started	31	31	30	30	31
Completed	31	31	29	29	31
Not completed	0	0	1	1	0
Withdrew: Did not receive treatment	0	0	1	1	0

Treated (ITT & Safety Population)

Participant flow — Treated (ITT & Safety Population)
Milestone	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Started	31	31	29	29	31
Completed	30	31	29	29	30
Not completed	1	0	0	0	1
Withdrew: Lost to follow-up	1	0	0	0	1

Outcome measures

PrimaryPart 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules

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

Time frame:: At Month 6
Reported as:: Number · Percentage of worms without Wolbachia

Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules
Percentage of worms without Wolbachia	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	6.0 (2.6 to 13.2)	2.3 (0.6 to 8.0)	0.0 (0.0 to 4.5)	0.0 (0.0 to 4.1)	2.6 (0.7 to 9.0)

SecondaryPart 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6

The percentage of live female adult worms with only degenerated embryos in the uterus per participant was determined after nodulectomy at the Month 6 visit.

Time frame:: At Month 6
Reported as:: Mean · Percentage of worms per participant

Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6
Percentage of worms per participant	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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 ± 2.086	7.67 ± 18.420	9.82 ± 19.578	7.59 ± 23.813	10.16 ± 18.064

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.036The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.530 (The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.852 (The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.366 (The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.)

SecondaryPart 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6

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

Time frame:: At Month 6
Reported as:: Mean · Percentage of worms per participant

Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6
Percentage of worms per participant	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6	84.27 ± 19.904	77.74 ± 32.445	78.03 ± 29.811	79.37 ± 27.013	79.52 ± 30.496

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.869 (The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.973 (The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.744 (The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.794 (The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.)

SecondaryPart 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6

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

Time frame:: At Month 6
Reported as:: Number · Percentage of participants

Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6
Percentage of participants	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6	22.7	26.9	41.7	31.8	30.4

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.559 (The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.786 (The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.423 (The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.920 (The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.)

SecondaryPart 1: Percentage of Participants Without Skin Microfilariae at Month 3

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

Time frame:: At Month 3
Reported as:: Number · Percentage of participants

Part 1: Percentage of Participants Without Skin Microfilariae at Month 3
Percentage of participants	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Percentage of Participants Without Skin Microfilariae at Month 3	3.2	3.2	3.6	3.6	3.3

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.981 (The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.981 (The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.960 (The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.960 (The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.)

SecondaryPart 1: Percentage of Participants Without Skin Microfilariae at Month 6

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

Time frame:: At Month 6
Reported as:: Number · Percentage of participants

Part 1: Percentage of Participants Without Skin Microfilariae at Month 6
Percentage of participants	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Percentage of Participants Without Skin Microfilariae at Month 6	0	0	0	0	7.1

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.157 (The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.150 (The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.150 (The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Chi-square test · p = =0.173 (The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.)

SecondaryPart 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3

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

Time frame:: Baseline, Month 3
Reported as:: Mean · Mean number of microfilariae/mg of skin

Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3
Mean number of microfilariae/mg of skin	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3	-0.44 ± 5.576	-7.99 ± 16.180	2.43 ± 13.148	1.36 ± 12.189	-1.03 ± 10.787

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.619 (The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.194 (The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.518 (The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.652 (The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)

SecondaryPart 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6

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

Time frame:: Baseline, Month 6
Reported as:: Mean · Mean number of microfilariae/mg of skin

Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6
Mean number of microfilariae/mg of skin	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6	-0.19 ± 6.330	5.55 ± 24.293	-1.19 ± 32.856	-2.72 ± 19.769	-1.67 ± 14.223

Statistical analysis

Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.386 (The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.279 (The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.385 (The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d vs Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days · Mann-Whitney U test · p = =0.755 (The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.)

SecondaryPart 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6

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

Time frame:: At Month 6
Reported as:: Number · Percentage of nodules

Part 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6
Percentage of nodules	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	0	0	0	0

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	0/31 (0%)	0/31 (0%)	14/31 (45.2%)
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	0/31 (0%)	2/31 (6.5%)	9/31 (29%)
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	0/30 (0%)	2/30 (6.7%)	13/30 (43.3%)
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)	0/30 (0%)	0/30 (0%)	10/30 (33.3%)
Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D)	0/122 (0%)	4/122 (3.3%)	46/122 (37.7%)
Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)	0/31 (0%)	4/31 (12.9%)	14/31 (45.2%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	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 (Arms A, B, C, and D)	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)
MYOCARDIAL ISCHAEMIACardiac disorders	0/31	0/31	1/30	0/30	1/122	0/31
RETINAL VEIN OCCLUSIONEye disorders	0/31	0/31	1/30	0/30	1/122	1/31
ELECTROCARDIOGRAM T WAVE INVERSIONInvestigations	0/31	0/31	1/30	0/30	1/122	0/31
ANAEMIABlood and lymphatic system disorders	0/31	0/31	0/30	0/30	0/122	1/31
ATRIOVENTRICULAR BLOCK SECOND DEGREECardiac disorders	0/31	0/31	0/30	0/30	0/122	1/31
RETINAL HAEMORRHAGEEye disorders	0/31	0/31	0/30	0/30	0/122	1/31
APPENDICITISInfections and infestations	0/31	1/31	0/30	0/30	1/122	0/31
PERIODONTITISInfections and infestations	0/31	1/31	0/30	0/30	1/122	0/31
ABDOMINAL INJURYInjury, poisoning and procedural complications	0/31	0/31	0/30	0/30	0/122	1/31
CHEST INJURYInjury, poisoning and procedural complications	0/31	0/31	0/30	0/30	0/122	1/31

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	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 (Arms A, B, C, and D)	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)
NEUTROPENIABlood and lymphatic system disorders	5/31	2/31	7/30	2/30	16/122	2/31
MALARIAInfections and infestations	3/31	1/31	3/30	2/30	9/122	6/31
VISUAL FIELD DEFECTEye disorders	3/31	2/31	1/30	0/30	6/122	2/31
SCHISTOSOMIASIS BLADDERInfections and infestations	3/31	1/31	2/30	1/30	7/122	1/31
EOSINOPHILIABlood and lymphatic system disorders	1/31	2/31	0/30	2/30	5/122	2/31
URINARY TRACT INFECTIONInfections and infestations	0/31	0/31	0/30	2/30	2/122	0/31
EYE PRURITUSEye disorders	0/31	0/31	1/30	0/30	1/122	2/31
ABDOMINAL PAIN UPPERGastrointestinal disorders	1/31	2/31	0/30	1/30	4/122	1/31
INGUINAL HERNIAGastrointestinal disorders	0/31	2/31	0/30	1/30	3/122	0/31
HYPOALBUMINAEMIAMetabolism and nutrition disorders	0/31	0/31	0/30	0/30	0/122	2/31

Baseline characteristics

Intention-to-Treat (ITT) population includes all randomized participants who received at least one dose of study drug

Age, Continuous
Age, Continuous(years)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Mean	43.6 ± 10.36	37.1 ± 11.73	40.1 ± 12.08	38.7 ± 10.78	38.5 ± 12.34	39.6 ± 11.55

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Female	2	4	0	4	6	16
Male	29	27	29	25	25	135

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days
Hispanic or Latino	—	—	—	—	—
Not Hispanic or Latino	—	—	—	—	—
Unknown or Not Reported	—	—	—	—	—

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	31	31	29	29	31	151
White	0	0	0	0	0	0
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Body weight
Body weight(kilograms)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Mean	53.55 ± 7.03	50.98 ± 6.04	53.48 ± 7.12	52.38 ± 6.42	49.77 ± 6.96	52.01 ± 6.80

Number of operable sites with onchocercomata
Number of operable sites with onchocercomata(sites)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Mean	1.5 ± 0.72	1.6 ± 0.67	1.6 ± 0.74	1.6 ± 1.02	1.5 ± 0.68	1.5 ± 0.76

Number of palpated onchocerca nodules
Number of palpated onchocerca nodules(nodules)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Mean	1.7 ± 0.83	1.7 ± 0.70	1.7 ± 1.03	1.8 ± 1.15	1.7 ± 0.93	1.7 ± 0.92

Skin microfilarial density
Skin microfilarial density(mf/mg of skin)	Part 1: ABBV-4083 400 mg + Albendazole Pbo 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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo 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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	Total
Mean	8.22 ± 12.25	26.55 ± 33.06	20.60 ± 35.52	19.45 ± 34.97	16.59 ± 25.81	18.23 ± 29.71

1 further baseline measures are reported on the registry.

Study locations

2 sites

Hôpital Général de Référence de Kimpese
Kimpese, Kongo Central, Congo, The Democratic Republic of the
Hôpital Général de Référence de Masi-Manimba
Masi-Manimba, Kwilu, Congo, The Democratic Republic of the

References and documents

Study documents

Study protocol ↗ · Nov 9, 2021
Statistical analysis plan ↗ · Mar 24, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Aug 2023, 27 months.

Results were first posted in Sep 2024, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: May 30, 2021
First posted: Jun 4, 2021
StartActual: May 22, 2021
Primary completionActual: Aug 29, 2023
CompletionActual: Aug 29, 2023
Results first posted: Sep 19, 2024
Last update: Sep 19, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04913610
Lead sponsor: AbbVie
Collaborators: Drugs for Neglected Diseases
Responsible party: Sponsor
First posted: Jun 4, 2021
Start date: May 22, 2021
Primary completion: Aug 29, 2023
Completion: Aug 29, 2023
Results posted: Sep 19, 2024
Last update: Sep 19, 2024

Study contacts

ABBVIE INC.

study director · AbbVie

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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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

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