A Phase 2/3 interventional study of Acoziborole in Trypanosomiasis, African, Gambiense Trypanosomiasis and Sleeping Sickness, sponsored by Drugs for Neglected Diseases. Completed at 12 sites in 2 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Drugs for Neglected Diseases · Phase 2/3, Interventional, and Treatment
The goal of this study is to assess efficacy and safety of acoziborole in adult participants with Trypanosoma brucei gambiense (T.b. gambiense) HAT, either early- or intermediate-stage HAT (first arm) or late-stage HAT (second arm). Participants will receive 3 tablets of 320 mg as a single oral dose of acoziborole in the fasting state on Day 1. Participants will stay in the hospital for observation for 15 days. In total, participants will be followed for 18 months.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 208 is above the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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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.
For patients with late-stage HAT:
For patients with early- or intermediate-stage HAT:
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Drug: Acoziborole
Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose.
Drug: Acoziborole
Acoziborole 3 x 320 mg tablets (fasted state)
Also known as: SCYX-7158
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted World Health Organization (WHO) Criteria
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys confidence interval (CI) of the estimate were provided.
Time frame: 18 months post-dose
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
Time frame: 12 months post-dose
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria
Success was defined according to an algorithm based on to the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
Time frame: 6 months post-dose
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted WHO Criteria
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 18, an unfavorable outcome earlier than end of Month 18, or signs and symptoms evoking a relapse at end of Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys CI of the estimate were provided.
Time frame: 18 months post-dose
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
Time frame: 12 months post-dose
Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
Time frame: 6 months post-dose
Estimated Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was Not a Proven Failure at Month 18, Based on the Kaplan-Meier Analysis of Time to Proven and Definitive Failure
Failure was defined as the first objective evidence of proven and definitive (sustainable) failure, defined as death; rescue medication use; trypanosomes in any body fluid at Month 6, 12, or 18; a cerebrospinal fluid (CSF) white blood cell count (WBC) of \>50 cells/μL at Month 6 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 12 and/or Month 18 and/or signs and symptoms evoking a relapse at Month 12 and/or Month 18); a CSF WBC \>20 cells/μL at Month 12 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 18 and/or signs and symptoms evoking a relapse at Month 18); or a CSF WBC \>20 cells/μL at Month 18. This outcome was analyzed using a Kaplan-Meier approach to estimate the cumulative rate of proven and definitive failures. The proven failure-free probability was estimated as an alternative (more liberal) success rate (95% CI) at Month 18 based on the Kaplan-Meier estimate of the rate of participants who were not proven failures
Time frame: 18 months post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Occurrence of any AEs, during the observation period and until 6 months post-dose (for non-serious AEs) and until 18 months post-dose for SAEs. Analysis of AEs was based on the concept of TEAEs, defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
Time frame: From the single dose acoziborole administration until 6 months post-dose for non-serious AEs and 18 months post-dose for serious AEs
Number of Participants With Serious TEAEs
Occurrence of any serious TEAEs during the observation period and until 18 months post-dose.
Time frame: From the single dose acoziborole administration until 18 months post-dose
Acoziborole Area Under the Curve From Time Zero to 240 Hours Post Dose (AUC0-240h) in Whole Blood Considering Concentration-time Data up to 240 Hours After a Single Administration
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in whole blood was assessed pre-dose and 4, 9, 24, 48, 72, 96, and 240 hours after the single administration, (on Days 1, 2, 3, 4, 5, and 11). Data up to 240 hours post dose were considered for this analysis. Descriptive statistics of the AUC0-240h were presented. The activity of acoziborole is more exposure-dependent than concentration-dependent, therefore the exposure (AUC) was used as the main PK data for efficacy purposes.
Time frame: Pre-dose and 4, 9, 24, 48, 72, 96, and 240 hours post-dose
Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Late-stage HAT
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with late-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
Time frame: 240 hours post-dose
Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Early- and Intermediate-stage HAT
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with early- and intermediate-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
Time frame: 240 hours post-dose
The study was conducted at Human African Trypanosomiasis (HAT) treatment centers in the Democratic Republic of Congo and Guinea. A total of 260 HAT-positive participants signed informed consent and 208 participants (167 with late- and 41 with early- and intermediate-stage HAT) were included in the study and treated. 52 participants were not included, mainly due to exclusion criteria met and/or inclusion criteria not met. Participants were enrolled between 11 October 2016 and 25 March 2019.
| Milestone | Late-stage HAT | Early- and Intermediate-stage HAT |
|---|---|---|
| Started | 167 | 41 |
| Completed | 160 | 41 |
| Not completed | 7 | 0 |
| Withdrew: Death | 4 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys confidence interval (CI) of the estimate were provided.
| percentage of participants | Late-stage HAT |
|---|---|
| Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted World Health Organization (WHO) Criteria | 95.2 (91.2 to 97.7) |
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
| percentage of participants | Late-stage HAT |
|---|---|
| Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria | 95.8 (91.9 to 98.1) |
Success was defined according to an algorithm based on to the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
| percentage of participants | Late-stage HAT |
|---|---|
| Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria | 94.6 (90.4 to 97.3) |
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 18, an unfavorable outcome earlier than end of Month 18, or signs and symptoms evoking a relapse at end of Month 18. An estimate of the percentage of participants whose treatment outcome was a success at Month 18 and the 95% Jeffreys CI of the estimate were provided.
| percentage of participants | Early- and Intermediate-stage HAT |
|---|---|
| Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted WHO Criteria | 100.0 (94.1 to 100.0) |
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 12, an unfavorable outcome earlier than end of Month 12, or signs and symptoms evoking a relapse at end of Month 12. For participants who continued after Month 12, data after Month 12 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 12 and the 95% Jeffreys CI of the estimate were provided.
| percentage of participants | Early- and Intermediate-stage HAT |
|---|---|
| Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 12 According to Adapted WHO Criteria | 100.0 (94.1 to 100.0) |
Success was defined according to an algorithm based on the criteria adapted from the WHO Recommendations of the Informal Consultation on Issues for Clinical Product Development for Human African Trypanosomiasis 2007 (WHO/CDS/NTD/IDM/2007.1). Success was defined as a cure or a probable cure. Failure was defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the end of Month 6, an unfavorable outcome earlier than end of Month 6, or signs and symptoms evoking a relapse at end of Month 6. For participants who continued after Month 6, data after Month 6 were considered in the algorithm. An estimate of the percentage of participants whose treatment outcome was a success at Month 6 and the 95% Jeffreys CI of the estimate were provided.
| percentage of participants | Early- and Intermediate-stage HAT |
|---|---|
| Percentage of Participants With Early- and Intermediate-stage HAT Whose Treatment Outcome Was a Success at Month 6 According to Adapted WHO Criteria | 100.0 (94.1 to 100.0) |
Failure was defined as the first objective evidence of proven and definitive (sustainable) failure, defined as death; rescue medication use; trypanosomes in any body fluid at Month 6, 12, or 18; a cerebrospinal fluid (CSF) white blood cell count (WBC) of \>50 cells/μL at Month 6 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 12 and/or Month 18 and/or signs and symptoms evoking a relapse at Month 12 and/or Month 18); a CSF WBC \>20 cells/μL at Month 12 followed by confirmation of failure (defined as CSF WBC \>20 cells/μL at Month 18 and/or signs and symptoms evoking a relapse at Month 18); or a CSF WBC \>20 cells/μL at Month 18. This outcome was analyzed using a Kaplan-Meier approach to estimate the cumulative rate of proven and definitive failures. The proven failure-free probability was estimated as an alternative (more liberal) success rate (95% CI) at Month 18 based on the Kaplan-Meier estimate of the rate of participants who were not proven failures
| percentage of participants | Late-stage HAT |
|---|---|
| Estimated Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was Not a Proven Failure at Month 18, Based on the Kaplan-Meier Analysis of Time to Proven and Definitive Failure | 96.0 (91.0 to 98.0) |
Occurrence of any AEs, during the observation period and until 6 months post-dose (for non-serious AEs) and until 18 months post-dose for SAEs. Analysis of AEs was based on the concept of TEAEs, defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
| Participants | Late-stage HAT | Early- and Intermediate-stage HAT | Any Stage HAT |
|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 127 | 28 | 155 |
Occurrence of any serious TEAEs during the observation period and until 18 months post-dose.
| Participants | Late-stage HAT | Early- and Intermediate-stage HAT | Any Stage HAT |
|---|---|---|---|
| Number of Participants With Serious TEAEs | 18 | 3 | 21 |
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in whole blood was assessed pre-dose and 4, 9, 24, 48, 72, 96, and 240 hours after the single administration, (on Days 1, 2, 3, 4, 5, and 11). Data up to 240 hours post dose were considered for this analysis. Descriptive statistics of the AUC0-240h were presented. The activity of acoziborole is more exposure-dependent than concentration-dependent, therefore the exposure (AUC) was used as the main PK data for efficacy purposes.
| h*ng/mL | Late-stage HAT | Early- and Intermediate-stage HAT | Any Stage HAT |
|---|---|---|---|
| Acoziborole Area Under the Curve From Time Zero to 240 Hours Post Dose (AUC0-240h) in Whole Blood Considering Concentration-time Data up to 240 Hours After a Single Administration | 2217617.78 ± 647696.87 | 2051104.88 ± 485620.67 | 2184795.53 ± 621610.31 |
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with late-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
| ng/mL | Late-stage HAT |
|---|---|
| Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Late-stage HAT | 100.8 ± 63.968 |
Participants received a single dose of 960 mg acoziborole on Day 1. Acoziborole in CSF of participants with early- and intermediate-stage HAT was assessed 240 hours after the single administration (on Day 11). Descriptive statistics of the acoziborole concentration were presented.
| ng/mL | Early- and Intermediate-stage HAT |
|---|---|
| Mean Acoziborole Concentration in CSF After 240 Hours in Participants With Early- and Intermediate-stage HAT | 81.4 ± 48.5 |
Collected over Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Late-stage HAT | 4/167 (2.4%) | 18/167 (10.8%) | 127/167 (76%) |
| Early- and Intermediate-stage HAT | 0/41 (0%) | 3/41 (7.3%) | 27/41 (65.9%) |
| Event | Late-stage HAT | Early- and Intermediate-stage HAT |
|---|---|---|
| Puerperal infectionInfections and infestations | 0/167 | 1/41 |
| Abdominal adhesionsGastrointestinal disorders | 0/167 | 1/41 |
| Postpartum haemorrhagePregnancy, puerperium and perinatal conditions | 0/167 | 1/41 |
| Umbilical cord prolapsePregnancy, puerperium and perinatal conditions | 0/167 | 1/41 |
| MalariaInfections and infestations | 2/167 | 0/41 |
| AppendicitisInfections and infestations | 1/167 | 0/41 |
| Extrapulmonary tuberculosisInfections and infestations | 1/167 | 0/41 |
| GastroenteritisInfections and infestations | 1/167 | 0/41 |
| Systemic infectionInfections and infestations | 1/167 | 0/41 |
| Typhoid feverInfections and infestations | 1/167 | 0/41 |
| Event | Late-stage HAT | Early- and Intermediate-stage HAT |
|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 39/167 | 13/41 |
| HeadacheNervous system disorders | 39/167 | 12/41 |
| Procedural headacheInjury, poisoning and procedural complications | 21/167 | 11/41 |
| PyrexiaGeneral disorders | 27/167 | 4/41 |
| MalariaInfections and infestations | 22/167 | 5/41 |
| AstheniaGeneral disorders | 13/167 | 5/41 |
| Weight increasedInvestigations | 19/167 | 1/41 |
| VomitingGastrointestinal disorders | 13/167 | 0/41 |
| InsomniaPsychiatric disorders | 13/167 | 2/41 |
| Back painMusculoskeletal and connective tissue disorders | 10/167 | 3/41 |
| Age, Continuous(years) | Late-stage HAT | Early- and Intermediate-stage HAT | Total |
|---|---|---|---|
| Mean | 32.4 ± 11.2 | 40.9 ± 15.0 | 34.0 ± 12.4 |
| Sex: Female, Male(Participants) | Late-stage HAT | Early- and Intermediate-stage HAT | Total |
|---|---|---|---|
| Female | 65 | 26 | 91 |
| Male | 102 | 15 | 117 |
| Race/Ethnicity, Customized(Participants) | Late-stage HAT | Early- and Intermediate-stage HAT | Total |
|---|---|---|---|
| Sub-Saharan African | 167 | 41 | 208 |
| Region of Enrollment(participants) | Late-stage HAT | Early- and Intermediate-stage HAT | Total |
|---|---|---|---|
| Guinea | 27 | 7 | 34 |
| Congo, The Democratic Republic of the | 140 | 34 | 174 |
| White blood cells (WBC) in cerebrospinal fluid (CSF)(cells/µL) | Late-stage HAT | Early- and Intermediate-stage HAT | Total |
|---|---|---|---|
| Mean | 398.8 ± 438.4 | 7.8 ± 5.3 | 321.3 ± 422.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data underlying the results of this study are available upon request because they contain potentially sensitive personal information, which must be de-identified at the individual level. Interested researchers may request access to de-identified participant data from Vivli, the data-sharing partner of the DNDi, commissioner of this study, at https://vivli.org/ourmember/dndi/.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Available upon request (see above)
Access criteria: Available upon request (see above)
Data sharing details ↗ · vivli.org
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SCYX 7158
Drugs for Neglected Diseases