A Phase 2/3 interventional study of Acoziborole and Placebo in Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection and Sleeping Sickness, sponsored by Drugs for Neglected Diseases. Completed at 7 sites in 2 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Drugs for Neglected Diseases · Phase 2/3, Interventional, and Treatment
Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b. gambiense), which is transmitted by the bite of the tsetse fly. HAT can be fatal without diagnosis and treatment. Several treatment options are currently available to treat HAT caused by the T.b. gambiense parasite (g-HAT), but these treatments can be administered only after demonstrating via microscopy the presence of the parasite in a body fluid. However, there are factors such as low parasitaemia and the complexity and low sensitivity of parasitological methods that make such demonstration difficult. It has been demonstrated that a variable proportion (mainly depending on the prevalence) of such g-HAT "sero-suspects" are confirmed cases and, therefore, remain potential reservoirs of the parasite and a source of new infections hindering the efforts to eliminate the disease.
The drug acoziborole was evaluated in a study called "DNDi-OXA-02-HAT". During this study, patients with g-HAT from the DRC and Guinea took a single dose of acoziborole. This study showed that acoziborole has a high efficacy and is safe for treating patients with confirmed g-HAT .
The present study is called "DNDi-OXA-04-HAT". It included seropositive participants from the DRC and Guinea who did not have parasites detected via microscopy in a body fluid. Its objective was to collect data on the safety and tolerability of a single dose of acoziborole compared to a placebo (i.e. a dummy treatment). The results of this study would help decide if acoziborole can be used in the population of g-HAT seropositive individuals and help eliminate the HAT disease.
HAT, or sleeping sickness, is a neglected tropical disease which is endemic in sub Saharan Africa. This vector-borne parasitic disease is transmitted by the bite of the tsetse fly and can be fatal without diagnosis and treatment. The parasites responsible for HAT are the protozoa T.b. gambiense and T.b. rhodesiense. In 2021-2022, HAT due to T.b. gambiense (g-HAT) represented 94% of all HAT cases detected.
Between 2018 and 2022, approximately 1.5 million people lived in areas (mainly rural areas of sub-Saharan Africa) considered to be at moderate to very high risk of HAT and where the disease is still considered as a public health problem. Thanks to efforts from national control programs, supported by the World Health Organization (WHO), non-governmental organizations, bilateral cooperations, the private sector (including pharmaceutical companies) and philanthropic organizations, the number of cases of g-HAT is consistently falling. With respectively 799 and 675 cases of g-HAT reported in 2022 and 2023, the global goal of sustainable disease elimination by 2030, including the interruption of g HAT transmission, is achievable. As the numbers of reported cases diminish, resources for surveillance and specialized screening also taper. This decrease, coupled with the loss of diagnostic skills and disease management expertise, could lead to a weak and less specialized HAT technical environment.
Several therapeutic options are currently available to treat g-HAT at either the hemolymphatic (early) stage or meningoencephalitic (late) stage. In December 2018, fexinidazole was registered for the treatment of g-HAT in DRC. Since then, all other endemic countries authorized the use of fexinidazole for the treatment of g-HAT. Fexinidazole is administered as a 10 day oral treatment to patients with early- or late-stage g-HAT. In patients with very advanced g-HAT, nifurtimox eflornithine combination therapy (NECT) remains the first line treatment, due to the increased risk of relapse in these patients when treated with fexinidazole. Children with g-HAT who have a body weight below 20 kg and/or are under 6 years of age are treated with pentamidine (early stage) or NECT (late stage). Pentamidine and NECT are administered as intravenous (IV) infusions performed daily, over 7 days.
Whilst the delivery of fexinidazole has simplified the management of g-HAT and has facilitated the integration of g-HAT treatment into general health systems, it is expected that the current investment in acoziborole as an oral, single-dose treatment will help boost elimination efforts envisioned for all stages of g-HAT. Indeed, treatment with NECT and fexinidazole are conditioned by the demonstration of the parasite in any body fluid via microscopy. However, factors such as low parasitemia as well as the complexity of parasitological diagnostic methods make this demonstration difficult.
Acoziborole, as a single-dose oral administration, was studied in the open-label pivotal Phase II/III study (DNDi-OXA-02-HAT). The study was conducted in patients with g-HAT (all stages) in the DRC and Guinea. The results of the study showed the high efficacy of acoziborole in any stage of g-HAT, which was comparable to the efficacy of the reference treatment NECT used as a yardstick. Safety data collected during this study did not identify any new safety signals. Based on these data, the benefit-risk balance for treating g-HAT patients (regardless of the disease stage) with acoziborole administered as a single oral dose of 960 mg appeared favorable.
The present study (DNDi-OXA-04-HAT) was conducted in g-HAT seropositive individuals who were unconfirmed parasitologically. It was designed with the objective of assessing the safety and tolerability of a single 960-mg dose of acoziborole compared with placebo during a follow-up period of 4 months.
This study included an exploratory Sub-Study named "TrypSkin" which had the main objective of assessing the presence of extravascular dermal T.b. gambiense in the enrolled population. Participation in this Sub-Study was optional.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 1,208 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.
Counted across the registry records on this site, refreshed daily.
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 women of :
Exclusion Criteria:
For women of :
Additional exclusion criteria for the TrypSkin exploratory sub-study:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Single dose administration of acoziborole, 3 tablets of 320 mg
Drug: Acoziborole
Single dose administration of acoziborole matching placebo, 3 tablets of 320 mg
Drug: Placebo
Single dose administration of acoziborole (3 tablets of 320 mg) on Day 1
Single dose administration of placebo (3 tablets of 320 mg) on Day 1
Occurrence of Any TEAEs
Occurrence and excess rate (95% CI) of any TEAEs.
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Malaria
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Acarodermatitis
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Abdominal Pain
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Enteritis
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Nausea
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Gastritis
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Headache
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Fatigue
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs - Blood Potassium Increased
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of TEAEs by Period of Occurrence
Occurrence and excess rate (95% CI) of any TEAEs, by period of occurrence.
Time frame: During hospitalization: from investigational product administration (Day 1) to Day 5 (End of Hospitalization); After hospitalization: from Day 5 (discharge) to the Month 4 follow-up visit (End of Study).
Occurrence of Serious TEAEs
Occurrence and excess rate (95% CI) of any serious TEAEs.
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of Severe Treatment-related TEAEs
Occurrence and excess rate (95% CI) of any serious TEAEs.
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of Any Treatment-related TEAEs
Occurrence of any treatment-related TEAEs by arm
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of Treatment-related TEAEs by PT
Occurrence of any treatment-related TEAEs by PT and by arm
Time frame: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
Occurrence of Adverse Events (AEs)
Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit. Of note, all AEs reported during this study were TEAEs.
Time frame: From Inform Consent signature (up to 2 days before treatment) to the Month 4 follow up visit (End of Study)
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Albumin
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Calcium
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Chloride
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Creatinine
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Glucose
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Potassium
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Sodium
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Total Bilirubin
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Bicarbonate
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Total Protein
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Hematology Parameter: Hemoglobin
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Hematology Parameter: Platelet Count
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in Hematology Parameter: Leukocytes
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
Time frame: From baseline to the Month 4 follow-up visit (End of Study).
Change From Baseline in ECG (Electrocardiogram) Parameter: Heart Rate (HR)
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an analysis of covariance (ANCOVA) model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: RR Interval
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: PR Interval
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: QRS Interval
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusting for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: QT Interval
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: QTcF
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Change From Baseline in ECG Parameter: QTcB
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Placebo-corrected Baseline-adjusted QTcF (ΔΔQTcF), Computed From a Concentration-response (C-R) Model Between Dry Blood Spot Concentration and Changes From Baseline in QTcF Parameter
Mixed linear model developed based on the model defined by Garnett et al (2017). The fixed effect parameters of the pre-specified model were intercept, slope for acoziborole concentrations, influence of baseline (centered on mean), and a treatment specific intercept (0=acoziborole, 1=Placebo). Sex and age were included in the model as fixed covariates.
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds
Incidence of abnormal values for PR, QRS, QTcB and QTcF at Day 1 and/or Day 5, according to pre-defined thresholds
Time frame: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)
| Milestone | Acoziborole | Placebo |
|---|---|---|
| Started | 907 | 301 |
| Completed | 906 | 300 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Acoziborole | Placebo |
|---|---|---|
| Started | 906 | 300 |
| Completed | 898 | 298 |
| Not completed | 8 | 2 |
| Withdrew: Lost to follow-up | 7 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Death | 0 | 1 |
Occurrence and excess rate (95% CI) of any TEAEs.
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of Any TEAEs | 195 | 69 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Malaria | 34 | 14 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Acarodermatitis | 13 | 3 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Abdominal Pain | 23 | 9 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Enteritis | 7 | 4 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Nausea | 7 | 3 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Gastritis | 6 | 3 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Headache | 53 | 8 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Fatigue | 14 | 5 |
Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of TEAEs - Blood Potassium Increased | 8 | 6 |
Occurrence and excess rate (95% CI) of any TEAEs, by period of occurrence.
| participants | Acoziborole | Placebo |
|---|---|---|
| During hospitalization | 124 | 38 |
| After hospitalization | 106 | 45 |
Occurrence and excess rate (95% CI) of any serious TEAEs.
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of Serious TEAEs | 3 | 4 |
Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit. Of note, all AEs reported during this study were TEAEs.
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of Adverse Events (AEs) | 195 | 69 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| U/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 20.6 ± 7.90 | 20.6 ± 9.44 |
| Day 5 | 21.9 ± 9.10 | 24.9 ± 13.42 |
| Month 1 | 19.2 ± 7.87 | 19.5 ± 11.70 |
| Month 4 | 20.8 ± 8.05 | 20.0 ± 6.71 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| g/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 3.22 ± 0.471 | 3.23 ± 0.433 |
| Day 5 | 3.12 ± 0.434 | 3.13 ± 0.414 |
| Month 1 | 3.27 ± 0.413 | 3.24 ± 0.391 |
| Month 4 | 3.22 ± 0.416 | 3.21 ± 0.398 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| U/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 99.8 ± 46.71 | 101.8 ± 52.59 |
| Day 5 | 91.9 ± 40.18 | 95.7 ± 46.43 |
| Month 1 | 96.6 ± 47.88 | 98.3 ± 53.97 |
| Month 4 | 98.6 ± 44.85 | 98.1 ± 49.90 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| U/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 32.8 ± 10.20 | 32.7 ± 12.41 |
| Day 5 | 33.8 ± 11.21 | 37.2 ± 19.04 |
| Month 1 | 31.0 ± 9.50 | 32.6 ± 30.32 |
| Month 4 | 31.8 ± 10.95 | 31.1 ± 8.51 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mmol/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 2.314 ± 0.1341 | 2.322 ± 0.1216 |
| Day 5 | 2.279 ± 0.1681 | 2.328 ± 0.1550 |
| Month 1 | 2.305 ± 0.1499 | 2.298 ± 0.1904 |
| Month 4 | 2.297 ± 0.1399 | 2.297 ± 0.1514 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mmol/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 105.3 ± 3.05 | 105.3 ± 2.74 |
| Day 5 | 105.2 ± 3.22 | 105.2 ± 3.53 |
| Month 1 | 105.1 ± 3.04 | 105.0 ± 3.23 |
| Month 5 | 104.8 ± 2.89 | 104.8 ± 3.18 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mg/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 0.84 ± 0.238 | 0.84 ± 0.230 |
| Day 5 | 0.83 ± 0.256 | 0.81 ± 0.233 |
| Month 1 | 0.82 ± 0.230 | 0.81 ± 0.220 |
| Month 4 | 0.81 ± 0.227 | 0.80 ± 0.223 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mg/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 88.581 ± 19.9540 | 87.087 ± 11.3391 |
| Day 5 | 89.801 ± 14.4784 | 89.410 ± 9.9699 |
| Month 1 | 91.715 ± 16.4756 | 90.207 ± 10.8139 |
| Month 4 | 91.226 ± 24.4440 | 89.225 ± 10.2205 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mmol/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 4.58 ± 0.537 | 4.60 ± 0.572 |
| Day 5 | 4.67 ± 0.607 | 4.59 ± 0.559 |
| Month 1 | 4.61 ± 0.589 | 4.60 ± 0.636 |
| Month 4 | 4.59 ± 0.540 | 4.61 ± 0.550 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mmol/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 136.7 ± 3.39 | 136.7 ± 3.61 |
| Day 5 | 137.2 ± 3.75 | 137.1 ± 3.97 |
| Month 1 | 137.2 ± 3.41 | 137.1 ± 3.94 |
| Month 4 | 137.1 ± 3.36 | 137.0 ± 3.38 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mg/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 0.879 ± 0.3457 | 0.869 ± 0.3469 |
| Day 5 | 0.739 ± 0.2957 | 0.809 ± 0.2506 |
| Month 1 | 0.818 ± 0.2641 | 0.884 ± 0.2591 |
| Month 4 | 0.887 ± 0.318 | 0.902 ± 0.2937 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mmol/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 27.5 ± 2.46 | 27.5 ± 2.60 |
| Day 5 | 28.5 ± 2.39 | 28.2 ± 2.40 |
| Month 1 | 28.0 ± 2.50 | 27.7 ± 2.44 |
| Month 4 | 28.0 ± 2.48 | 27.9 ± 2.58 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| g/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 7.63 ± 0.589 | 7.65 ± 0.565 |
| Day 5 | 7.46 ± 0.566 | 7.61 ± 0.584 |
| Month 1 | 7.55 ± 0.547 | 7.59 ± 0.583 |
| Month 4 | 7.54 ± 0.573 | 7.57 ± 0.591 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| mg/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 7.434 ± 2.5471 | 7.415 ± 2.6550 |
| Day 5 | 8.402 ± 2.6432 | 8.358 ± 2.4459 |
| Month 1 | 6.951 ± 2.2998 | 6.820 ± 2.5365 |
| Month 4 | 7.501 ± 2.3841 | 7.383 ± 2.2759 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| g/dL | Acoziborole | Placebo |
|---|---|---|
| Baseline | 13.09 ± 1.706 | 13.10 ± 1.554 |
| Day 5 | 12.57 ± 1.627 | 12.95 ± 1.513 |
| Month 1 | 12.78 ± 1.550 | 13.00 ± 1.489 |
| Month 4 | 13.04 ± 1.644 | 12.93 ± 1.646 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| 10^9 platelets/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 229.1 ± 64.75 | 229.0 ± 63.04 |
| Day 5 | 230.5 ± 65.20 | 226.5 ± 65.84 |
| Month 1 | 227.7 ± 62.55 | 227.6 ± 64.01 |
| Month 4 | 228.4 ± 60.29 | 229.1 ± 63.44 |
Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.
| 10^9 Leukocytes/L | Acoziborole | Placebo |
|---|---|---|
| Baseline | 5.53 ± 1.576 | 5.46 ± 1.539 |
| Day 5 | 5.64 ± 1.563 | 5.60 ± 1.507 |
| Month 1 | 5.51 ± 1.446 | 5.50 ± 1.427 |
| Month 4 | 5.49 ± 1.385 | 5.52 ± 1.426 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an analysis of covariance (ANCOVA) model adjusted for sex and age.
| beats/min | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 66.8 ± 10.7 | 70.0 ± 12.1 |
| Day 5 | 66.4 ± 9.9 | 69.1 ± 12.6 |
| Change from baseline at Day 5 (Δ) | -0.4 ± 8.4 | -0.9 ± 8.3 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 921.6 ± 143.8 | 882.2 ± 149.3 |
| Day 5 | 923.5 ± 137.4 | 893.7 ± 149.4 |
| Change from baseline at Day 5 (Δ) | 1.9 ± 103.5 | 11.5 ± 94.8 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 162.4 ± 25.2 | 162.2 ± 20.3 |
| Day 5 | 161.4 ± 23.0 | 161.9 ± 20.5 |
| Change from baseline at Day 5 (Δ) | -1.0 ± 1.11 | -0.3 ± 12.8 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusting for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 82.2 ± 8.2 | 82.3 ± 10.2 |
| Day 5 | 81.8 ± 8.4 | 82.5 ± 9.0 |
| Change from baseline at Day 5 (Δ) | -0.5 ± 5.4 | 0.3 ± 4.5 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 389.5 ± 27.8 | 383.0 ± 33.1 |
| Day 5 | 377.3 ± 26.7 | 383.1 ± 30.8 |
| Change from baseline at Day 5 (Δ) | -12.1 ± 21.4 | 0.1 ± 20.4 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 401.3 ± 20.0 | 400.5 ± 24.0 |
| Day 5 | 388.5 ± 20.5 | 399.0 ± 21.8 |
| Change from baseline at Day 5 (Δ) | -12.8 ± 13.3 | -1.5 ± 13.8 |
Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.
| ms | Acoziborole | Placebo |
|---|---|---|
| Day 1 (pre-dose) | 407.9 ± 23.0 | 410.1 ± 25.8 |
| Day 5 | 394.6 ± 23.3 | 407.8 ± 24.6 |
| Change from baseline at Day 5 (Δ) | -13.3 ± 14.2 | -2.3 ± 14.8 |
Mixed linear model developed based on the model defined by Garnett et al (2017). The fixed effect parameters of the pre-specified model were intercept, slope for acoziborole concentrations, influence of baseline (centered on mean), and a treatment specific intercept (0=acoziborole, 1=Placebo). Sex and age were included in the model as fixed covariates.
| ms | Acoziborole |
|---|---|
| Placebo-corrected Baseline-adjusted QTcF (ΔΔQTcF), Computed From a Concentration-response (C-R) Model Between Dry Blood Spot Concentration and Changes From Baseline in QTcF Parameter | -12.9 (-14.3 to -11.3) |
Incidence of abnormal values for PR, QRS, QTcB and QTcF at Day 1 and/or Day 5, according to pre-defined thresholds
| Participants | Acoziborole | Placebo |
|---|---|---|
| HR <40 beats/min | 0 | 0 |
| HR >120 beats/min | 0 | 0 |
| HR relative change from baseline >25% | 6 | 2 |
| PR >220 ms | 2 | 1 |
| PR relative change from baseline >25% | 0 | 0 |
| QRS >120 ms | 1 | 0 |
| QRS relative change from baseline >25% | 0 | 0 |
| QTcF >450 ms and ≤480 ms | 2 | 1 |
| QTcF >480 ms and ≤500 ms | 0 | 0 |
| QTcF >500 ms | 0 | 0 |
| QTcF change from baseline >30 ms and ≤60 ms | 0 | 0 |
| QTcF change from >60 ms | 0 | 0 |
| QTcB >450 ms and ≤480 ms | 3 | 1 |
| QTcB >480 ms and ≤500 ms | 1 | 0 |
| QTcB >500 ms | 0 | 0 |
| QTcB change from baseline >30 ms and ≤60 ms | 1 | 1 |
| QTcB change from >60 ms | 0 | 0 |
Occurrence and excess rate (95% CI) of any serious TEAEs.
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of Severe Treatment-related TEAEs | 0 | 0 |
Occurrence of any treatment-related TEAEs by arm
| Participants | Acoziborole | Placebo |
|---|---|---|
| Occurrence of Any Treatment-related TEAEs | 59 | 17 |
Occurrence of any treatment-related TEAEs by PT and by arm
| Participants | Acoziborole | Placebo |
|---|---|---|
| SOC: Nervous system disorders | 28 | 5 |
| Abdominal pain | 14 | 6 |
| Fatigue | 8 | 5 |
| Decreased appetite | 6 | 1 |
| Nausea | 5 | 2 |
| Dizziness | 5 | 1 |
| Hot flush | 3 | 0 |
| Pyrexia | 2 | 0 |
| Insomia | 2 | 0 |
| Vomiting | 1 | 1 |
| Dysgeusia | 1 | 0 |
| Diarrhoea | 1 | 0 |
| Enteritis | 1 | 0 |
| Dyspepsia | 1 | 0 |
| Gastrointestinal sounds abnormal | 1 | 0 |
| Asthenia | 1 | 0 |
| Electrocardiogram QT prolonged | 1 | 0 |
| Muscle spasms | 1 | 0 |
| Tachycardia | 0 | 1 |
Collected over From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acoziborole | 0/906 (0%) | 3/906 (0.3%) | 137/906 (15.1%) |
| Placebo | 1/300 (0.3%) | 4/300 (1.3%) | 45/300 (15%) |
| Event | Acoziborole | Placebo |
|---|---|---|
| AppendicitisInfections and infestations | 0/906 | 1/300 |
| MalariaInfections and infestations | 0/906 | 1/300 |
| Wound infectionInfections and infestations | 0/906 | 1/300 |
| Abortion inducedSurgical and medical procedures | 0/906 | 1/300 |
| Uterine prolapseReproductive system and breast disorders | 1/906 | 0/300 |
| Vaginal haemorrhageReproductive system and breast disorders | 1/906 | 0/300 |
| AbortionPregnancy, puerperium and perinatal conditions | 1/906 | 0/300 |
| Event | Acoziborole | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 53/906 | 8/300 |
| MalariaInfections and infestations | 34/906 | 13/300 |
| Abdominal painGastrointestinal disorders | 23/906 | 9/300 |
| Blood potassium increasedInvestigations | 8/906 | 6/300 |
| FatigueGeneral disorders | 14/906 | 5/300 |
| AcarodermatitisInfections and infestations | 13/906 | 3/300 |
| EnteritisGastrointestinal disorders | 7/906 | 4/300 |
| NauseaGastrointestinal disorders | 7/906 | 3/300 |
| GastritisGastrointestinal disorders | 6/906 | 3/300 |
Safety set (based on the actual treatment received, determined by the presence/absence of acoziborole in blood)
| Age, Continuous(years) | Acoziborole | Placebo | Total |
|---|---|---|---|
| Mean | 37.3 ± 17.35 | 36.4 ± 16.38 | 37.1 ± 17.11 |
| Age, Customized(Participants) | Acoziborole | Placebo | Total |
|---|---|---|---|
| Adolescent (15-17 years) | 101 | 28 | 129 |
| Adult (≥18 years) | 805 | 272 | 1077 |
| Sex: Female, Male(Participants) | Acoziborole | Placebo | Total |
|---|---|---|---|
| Female | 476 | 158 | 634 |
| Male | 430 | 142 | 572 |
| Race (NIH/OMB)(Participants) | Acoziborole | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 906 | 300 | 1206 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Acoziborole | Placebo | Total |
|---|---|---|---|
| Guinea | 132 | 44 | 176 |
| Republic of the Congo | 774 | 256 | 1030 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2021 to primary completion in Aug 2023, 19 months.
Results were first posted in Mar 2025, 1 year 7 months after primary completion.
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Studies of the drug tested here: SCYX 7158
Drugs for Neglected Diseases