OnchocerciasisPhase 2NCT04913610

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 study testing ABBV-4083 and Albendazole in people with Onchocerciasis, run by AbbVie at 2 sites in Democratic Republic of the Congo.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Onchocerciasis
What is being tested?: ABBV-4083 and Albendazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: 2 sitesDemocratic Republic of the Congo
Study dates: 22 May 2021to 29 Aug 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Onchocerca volvulus infection at time of Screening:
Presence of at least one excisable subcutaneous nodule/ onchocercoma detected on palpation;
O. volvulus infection diagnosed by skin snip method: documented mfpositivity on skin assessment on at least 2 out of 4 skin snips.
Body weight > 40 kg at Screening.
For women of child-bearing potential, acceptance of the requirement to use a highly effective form of birth control from Day 0 until at least 1 month after the final intake of study drug (Part 1: day 43; Part 2: 1 month after the administration of ivermectin or matching placebo at the Month 6 visit). Choice of birth control method must be clearly documented.

Who cannot join

Participation in any studies other than purely observational studies within 3 months prior to Screening, or during the trial, or within 5 times the half-life of the drug tested in the previous clinical trial or is currently in the follow-up period for any clinical trial.
Any vaccination within 4 weeks prior to investigational medicinal product (IMP) administration.
Acute infection and/or febrile illness requiring therapy within 14 days prior to IMP administration.
Administration of medication or herbal preparations as follows:
Administration of any medication (with the exception of diclofenac, paracetamol, ibuprofen and aspirin) or herbal preparation within 14 days prior to IMP administration;
Use of strong CYP3A inhibitors or inducers including but not limited to ritonavir, ketoconazole, rifampicin, phenytoin, phenobarbital, carbamazepine, cimetidine within 14 days or 10 half-lives, whichever is longer, prior to IMP administration;

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Use of other drugs known to interact with albendazole i.e. praziquantel, theophylline or dexamethasone, within 14 days or 10 half-lives, whichever is longer, prior to IMP administration;
Antifilarial therapies, or medication that may have an antifilarial effect.
Requirement for and inability to avoid ivermectin during the first 6 months after IMP administration. Requirement for albendazole during the first 28 days after IMP administration or more than one dose per year thereafter given in MDA.
Presence of any of the following at Screening, that could interfere with the objectives of the trial or the safety of the participant, in the opinion of the Investigator:
Clinically significant abnormal physical and/or neurological examination or laboratory findings;
Any clinically significant medical condition. Including, but not limited to significant acute or chronic liver or kidney condition or cardiovascular disease, active infection, current or previous epilepsy, known human immunodeficiency virus infection, disclosed by review of medical history or concomitant medication.
Ophthalmological history or conditions that could interfere with the objectives of the trial or compromise the safety of the subject in the opinion of the Investigator, assessed at Screening.
History of drug or alcohol abuse within 6 months prior to IMP administration.
Use of alcohol within 48 hours and/or use of drugs of abuse within 15 days before IMP administration.
Clinically significant history of cardiac abnormality, and/or relevant pathological abnormalities in the ECG in the screening period.
Abnormal laboratory test results at Screening.
History of severe drug allergy, non-allergic drug reactions, severe adverse reaction to any drug, or multiple drug allergies.
Known hypersensitivity to any ingredient of the IMPs, including the active ingredient of ABBV-4083, macrolides, albendazole or to ivermectin or to any medication used during the study.
Blood donation within 8 weeks prior to Screening or blood transfusion received within 1 year prior to Screening.
Coincidental infection with high Loa loa load at Screening.
Current hyperreactive onchodermatitis or severe manifestation due to onchocerciasis.
Any other past or current condition that the Investigator feels would exclude the participant from the study or place the subject at undue risk.
For women of child-bearing potential: pregnant, based on date of last menstrual period, and pregnancy test prior to first intake of IMP, or breastfeeding.
Unwilling or unable to comply with the requirements of the study protocol for the entire duration of the study, in the opinion of the Investigator.
Unable to participate in the study as per local law, if applicable.

Trial locations and contacts

2 sites in 1 country.

Democratic Republic of the Congo2 sites

Hôpital Général de Référence de Kimpese
Kimpese, Bas-Congo Province
Hôpital Général de Référence de Masi-Manimba
Masi-Manimba, Kwilu

Other trials in Democratic Republic of the Congo

About this study

Official title: A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics

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: Onchocerciasis
Being tested: ABBV-4083, Placebo for ABBV-4083, Albendazole, Placebo for Albendazole
Keywords: Onchocerciasis, Onchocerca volvulus, River blindness, ABBV-4083, Tylamac
Medical subject headings: Onchocerciasis, Onchocerciasis, Ocular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBV-4083Drug
Also called Tylamac
Oral Capsule
Placebo for ABBV-4083Drug
Oral Capsule
AlbendazoleDrug
Also called Zentel
Oral encapsulated tablets
Placebo for AlbendazoleDrug
Oral Capsule

Study groups in NCT04913610
Study group	Role	What they receive
Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by placebo capsules for ABBV-4083 for 7 days. Receives: Drug: ABBV-4083; Drug: Placebo for ABBV-4083; Drug: Placebo for Albendazole
Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus placebo capsules for albendazole for 7 days followed by ABBV-4083 400 mg administered orally as capsules for 7 days. Receives: Drug: ABBV-4083; Drug: Placebo for Albendazole
Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 7 days followed by placebo capsules for ABBV-4083 for 7 days. Receives: Drug: ABBV-4083; Drug: Placebo for ABBV-4083; Drug: Albendazole
Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d	Experimental	Participants received ABBV-4083 400 mg administered orally as capsules plus albendazole 400 mg capsules for 3 days followed by ABBV-4083 400 mg and placebo capsules for albendazole for 4 days followed by placebo capsules for ABBV-4083 for 7 days. Receives: Drug: ABBV-4083; Drug: Placebo for ABBV-4083; Drug: Albendazole; Drug: Placebo for Albendazole
Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days	Experimental	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. Receives: Drug: Placebo for ABBV-4083; Drug: Albendazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Month 6

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 202129 Aug 2023

First posted4 Jun 2021
Study start22 May 2021
Primary completion29 Aug 2023
Study completion29 Aug 2023

Why it stopped: Strategic considerations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OnchocerciasisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04913610
Sponsor's protocol ID: B18-894
Other IDs: DNDi-TYL-01
Status last verified: Aug 2024
First submitted: 30 May 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Onchocerciasis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics
ClinicalTrials.gov ID: NCT04913610
Acronym / sponsor ID: B18-894
Conditions: Onchocerciasis
Keywords: Onchocerciasis, Onchocerca volvulus, River blindness, ABBV-4083, Tylamac
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic considerations
Enrolment: 153 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Collaborators: Drugs for Neglected Diseases
Study start: 22 May 2021 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 29 Aug 2023 (actual)
First posted: 4 Jun 2021 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days	Experimental	Drug: ABBV-4083, Drug: Placebo for ABBV-4083, Drug: Placebo for AlbendazoleParticipants 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	Experimental	Drug: ABBV-4083, Drug: Placebo for AlbendazoleParticipants 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	Experimental	Drug: ABBV-4083, Drug: Placebo for ABBV-4083, Drug: AlbendazoleParticipants 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	Experimental	Drug: ABBV-4083, Drug: Placebo for ABBV-4083, Drug: Albendazole, Drug: Placebo for AlbendazoleParticipants 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	Experimental	Drug: Placebo for ABBV-4083, Drug: AlbendazoleParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of Onchocerca volvulus infection at time of Screening:
Body weight > 40 kg at Screening.
For women of child-bearing potential, acceptance of the requirement to use a highly effective form of birth control from Day 0 until at least 1 month after the final intake of study drug (Part 1: day 43; Part 2: 1 month after the administration of ivermectin or matching placebo at the Month 6 visit). Choice of birth control method must be clearly documented.

Key exclusion criteria (26 listed)

Participation in any studies other than purely observational studies within 3 months prior to Screening, or during the trial, or within 5 times the half-life of the drug tested in the previous clinical trial or is currently in the follow-up period for any clinical trial.
Any vaccination within 4 weeks prior to investigational medicinal product (IMP) administration.
Acute infection and/or febrile illness requiring therapy within 14 days prior to IMP administration.
Administration of medication or herbal preparations as follows:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABBV-4083Also: TylamacOral Capsule	Drug	Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days, Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days, Part 1: ABBV-4083 400 mg + albendazole pbo 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
Placebo for ABBV-4083Oral Capsule	Drug	Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days, Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days, Part 1: ABBV-4083 pbo + 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
AlbendazoleAlso: ZentelOral encapsulated tablets	Drug	Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days, Part 1: ABBV-4083 pbo + 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
Placebo for AlbendazoleOral Capsule	Drug	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 pbo 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

Primary outcome

Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules
Time frame: 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.

8 secondary outcomes

Part 1: Percentage of Live Female Adult Worms With Only Degenerated Embryos in the Uterus Per Participant at Month 6
Time frame: At Month 6
Part 1: Percentage of Live Female Adult Worms Out of All Female Adult Worms Per Participant at Month 6
Time frame: At Month 6
Part 1: Percentage of Participants Without Microfilariae in Nodular Tissue at Month 6
Time frame: At Month 6
Part 1: Percentage of Participants Without Skin Microfilariae at Month 3
Time frame: At Month 3
Part 1: Percentage of Participants Without Skin Microfilariae at Month 6
Time frame: At Month 6
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 3
Time frame: Baseline, Month 3
Part 1: Mean Within-Participant Change From Baseline in Skin Microfilarial Density at Month 6
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
Time frame: At Month 6

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days	31	31
Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days	31	31
Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	30	29
Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d	30	29
Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days	31	31

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

Time frame: At Month 6. Number (95% Confidence Interval). Unit: Percentage of worms without Wolbachia

Measure	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 Pbo for 7 Days n = 22	Part 1: ABBV-4083 400 mg + Albendazole Pbo for 7 Days, Then ABBV-4083 400 mg for 7 Days n = 23	Part 1: ABBV-4083 400 mg + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n = 22	Part 1: ABBV-4083/Albendazole 400 mg 3 d; ABBV-4083 400 mg/Albendazole Pbo 4 d; ABBV-4083 Pbo 7 d n = 21	Part 1: ABBV-4083 Pbo + Albendazole 400 mg for 7 Days, Then ABBV-4083 Pbo for 7 Days n = 20
Value	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)

Population analysed: 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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 5% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ABBVIE INC. study director

AbbVie

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-4083 and Albendazole in people with Onchocerciasis, run by AbbVie at 2 sites in Democratic Republic of the Congo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Live Female Adult Worms Without Wolbachia at Month 6 as Assessed By Immunohistology of Nodules (time frame: At Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.