TrichuriasisPhase 3MoxipedNCT06188715
Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
A Phase 3 study testing Moxidectin 2 mg Oral Tablet and Albendazole 400 mg Oral Tablet in people with Trichuriasis and Ascariasis, run by Jennifer Keiser at 1 site in Tanzania.
Trial summary
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Trichuriasis, Ascariasis, Hookworm Infections
- What is being tested?
- Moxidectin 2 mg Oral Tablet and Albendazole 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteTanzania
- Study dates
- 14 May 2024to 5 Aug 2024
- Phase
- Phase 3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- individuals aged 6-12 years (confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Who cannot join
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <80 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., moxidectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- pregnancy (female participants aged 10-12 years)
- concurrent participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children: a Double-blind Randomised Controlled Superiority Trial
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Read the detailed description
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among SAC receiving moxidectin/albendazole combination therapy and albendazole monotherapy.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of moxidectin in T. trichiura infected SAC.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs. Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Being tested
- Moxidectin 2 mg Oral Tablet, Albendazole 400 mg Oral Tablet, Placebo Moxidectin, Placebo Albendazole
- Keywords
- Moxidectin, Albendazole, Anthelminthics, Trichuris trichiura, Ascaris lumbricoides, Hookworm, Whipworm, Soil-transmitted helminths
- Medical subject headings
- Trichuriasis, Ascariasis, Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidectin 2 mg Oral TabletDrug
Tablets of 2 mg moxidectin
Albendazole 400 mg Oral TabletDrug
Also called Zentel®
Tablets of 400 mg albendazole
Placebo MoxidectinDrug
Placebo tablets for moxidectin
Placebo AlbendazoleDrug
Placebo tablets for albendazole
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Moxidectin 4/8 mg & Albendazole | Experimental | Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Moxidectin 2 mg Oral Tablet; Drug: Albendazole 400 mg Oral Tablet |
| Arm B: Albendazole | Active comparator | Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Albendazole 400 mg Oral Tablet; Drug: Placebo Moxidectin |
| Arm C: Placebo | Placebo comparator | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Placebo Moxidectin; Drug: Placebo Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate (CR) Against T. Trichiura
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Secondary outcomes (9)
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rate (CR) Against A. Lumbricoides
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rate (CR) Against Hookworm
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Number of Participants Reporting Adverse Events (AEs)
Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
Measured: 3 hours, 24 hours and 14-21 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start14 May 2024
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrichuriasisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188715
- Sponsor's protocol ID
- Moxiped_1
- Acronym
- Moxiped
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2023
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schnoz A, Sprecher VP, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of moxidectin-albendazole combination therapy for Trichuris trichiura infections in school-aged children: a double-blind, randomised, controlled, superiority trial. Lancet Infect Dis. 2025 Dec;25(12):1325-1335. doi: 10.1016/S1473-3099(25)00344-5. Epub 2025 Jul 14.
PubMed 40675166
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children: a Double-blind Randomised Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT06188715
- Acronym / sponsor ID
- Moxiped / Moxiped_1
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Keywords
- Moxidectin, Albendazole, Anthelminthics, Trichuris trichiura, Ascaris lumbricoides, Hookworm, Whipworm, Soil-transmitted helminths
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 14 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Detailed description
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among SAC receiving moxidectin/albendazole combination therapy and albendazole monotherapy.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of moxidectin in T. trichiura infected SAC.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs. Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Moxidectin 4/8 mg & Albendazole | Experimental | Drug: Moxidectin 2 mg Oral Tablet, Drug: Albendazole 400 mg Oral TabletCombination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm B: Albendazole | Active comparator | Drug: Albendazole 400 mg Oral Tablet, Drug: Placebo MoxidectinPlacebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm C: Placebo | Placebo comparator | Drug: Placebo Moxidectin, Drug: Placebo AlbendazolePlacebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- individuals aged 6-12 years (confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Key exclusion criteria (7 listed)
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <80 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., moxidectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
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 |
|---|---|---|
| Moxidectin 2 mg Oral TabletTablets of 2 mg moxidectin | Drug | Arm A: Moxidectin 4/8 mg & Albendazole |
| Albendazole 400 mg Oral TabletAlso: Zentel®Tablets of 400 mg albendazole | Drug | Arm A: Moxidectin 4/8 mg & Albendazole, Arm B: Albendazole |
| Placebo MoxidectinPlacebo tablets for moxidectin | Drug | Arm B: Albendazole, Arm C: Placebo |
| Placebo AlbendazolePlacebo tablets for albendazole | Drug | Arm C: Placebo |
Primary outcome
Cure Rate (CR) Against T. Trichiura
Time frame: 14-21 days post-treatment
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
9 secondary outcomes
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Cure Rate (CR) Against A. Lumbricoides
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Cure Rate (CR) Against Hookworm
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Number of Participants Reporting Adverse Events (AEs)
Time frame: 3 hours, 24 hours and 14-21 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40675166Schnoz A, Sprecher VP, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of moxidectin-albendazole combination therapy for Trichuris trichiura infections in school-aged children: a double-blind, randomised, controlled, superiority trial. Lancet Infect Dis. 2025 Dec;25(12):1325-1335. doi: 10.1016/S1473-3099(25)00344-5. Epub 2025 Jul 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxidectin 2 mg Oral Tablet and Albendazole 400 mg Oral Tablet in people with Trichuriasis and Ascariasis, run by Jennifer Keiser at 1 site in Tanzania.
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 7 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: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2025). 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?
Cure Rate (CR) Against T. Trichiura (time frame: 14-21 days post-treatment). 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 NCT06188715, which also lists 1 linked publication.
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 2025.