Trial · NCT04913610

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

NCT04913610, Phase 2, Terminated, AbbVie; results first posted 2024-09-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT04913610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04913610

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT04913610
Status: Terminated
Phases: Phase 2
Enrollment: 153 participants, actual
Lead sponsor: AbbVie
Conditions: Onchocerciasis
Interventions: ABBV-4083, Placebo for ABBV-4083, Albendazole, Placebo for Albendazole
First posted: 2021-06-04
Last updated: 2024-09-19
Results first posted: 2024-09-19

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	At Month 6	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	Percentage of worms without Wolbachia	NUMBER
SECONDARY	Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6	At Month 6	Intention-to-treat (ITT) population who had live female adult worms that contained either normal embryos, degenerated embryos, or both	Percentage of worms per participant	MEAN
SECONDARY	Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6	At Month 6	Intention-to-treat (ITT) population who had female adult worms	Percentage of worms per participant	MEAN
SECONDARY	Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6	At Month 6	Intention-to-treat (ITT) population who had post-baseline values at Month 6	Percentage of participants	NUMBER
SECONDARY	Part 1: Percentage of Participants Without Skin Microfilariae at Month 3	At Month 3	Intention-to-treat (ITT) population who had post-baseline values at Month 3	Percentage of participants	NUMBER
SECONDARY	Part 1: Percentage of Participants Without Skin Microfilariae at Month 6	At Month 6	Intention-to-treat (ITT) population who had post-baseline values at Month 6	Percentage of participants	NUMBER
SECONDARY	Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3	Baseline, Month 3	Intention-to-treat (ITT) population who had values at Baseline and Month 3	Mean number of microfilariae/mg of skin	MEAN
SECONDARY	Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6	Baseline, Month 6	Intention-to-treat (ITT) population who had values at Baseline and Month 6	Mean number of microfilariae/mg of skin	MEAN
SECONDARY	Part 1: Percentage of Nodules That Contain at Least 1 Live Female Adult Worm Without Wolbachia Assessed by PCR at Month 6	At Month 6	Intention-to-treat (ITT) population who had live female adult worms	Percentage of nodules	NUMBER

Source ClinicalTrials.gov

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	6.0	95% Confidence Interval 2.6 to 13.2	Percentage of worms without Wolbachia
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	2.3	95% Confidence Interval 0.6 to 8.0	Percentage of worms without Wolbachia
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	0.0	95% Confidence Interval 0.0 to 4.5	Percentage of worms without Wolbachia
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	0.0	95% Confidence Interval 0.0 to 4.1	Percentage of worms without Wolbachia
Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	2.6	95% Confidence Interval 0.7 to 9.0	Percentage of worms without Wolbachia
Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	0.48	Standard Deviation 2.086	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	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	7.67	Standard Deviation 18.420	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	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	9.82	Standard Deviation 19.578	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	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	7.59	Standard Deviation 23.813	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	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	10.16	Standard Deviation 18.064	Percentage of worms per participant

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized Participants	STARTED	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	31
Randomized Participants	STARTED	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	31
Randomized Participants	STARTED	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	30
Randomized Participants	STARTED	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	30
Randomized Participants	STARTED	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	31
Randomized Participants	COMPLETED	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	31
Randomized Participants	COMPLETED	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	31
Randomized Participants	COMPLETED	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	29
Randomized Participants	COMPLETED	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	29
Randomized Participants	COMPLETED	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	31

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events138

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	EOSINOPHILIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	1	31	1
other	EOSINOPHILIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	2	31	2
other	EOSINOPHILIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	0	30	0
other	EOSINOPHILIA	Blood and lymphatic system disorders	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)	2	30	2
other	EOSINOPHILIA	Blood and lymphatic system disorders	Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D)	5	122	5
other	EOSINOPHILIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)	2	31	2
other	NEUTROPENIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	5	31	5
other	NEUTROPENIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	2	31	2
other	NEUTROPENIA	Blood and lymphatic system disorders	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	7	30	7
other	NEUTROPENIA	Blood and lymphatic system disorders	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)	2	30	2

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	0	31
Total, all-cause mortality	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	0	31
Total, all-cause mortality	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	0	30
Total, all-cause mortality	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
Total, all-cause mortality	Participants Randomized to Receive ABBV-4083 (Arms A, B, C, and D)	0	122
Total, all-cause mortality	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (E)	0	31
Total, other adverse events	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days (A)	14	31
Total, other adverse events	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days (B)	9	31
Total, other adverse events	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days (C)	13	30
Total, other adverse events	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d(D)	10	30

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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