Rifampicin-Resistant Pulmonary TuberculosisPhase 3QUANTUM-TBNCT07209761
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
A Phase 3 study testing Bedaquiline, Quabodepistat and Pretomanid in people with Rifampicin-Resistant Pulmonary Tuberculosis and Multidrug-Resistant Pulmonary Tuberculosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 42 sites in 10 countries.
Trial summary
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or multidrug-resistant pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
- What is being tested?
- Bedaquiline, Quabodepistat and Pretomanid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 16 Oct 2025to 29 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the investigator, to comply with all trial requirements (if under 18 years of age: participant assent AND parent/legal guardian consent are required).
- Male or female participants aged ≥14 years at screening.
- Body weight ≥30.0 kg at screening.
- Documented pulmonary TB: Mycobacterium tuberculosis (Mtb) confirmed by Xpert MTB/RIF Ultra with a semi-quantitative result of "low," "medium," or "high" on the screening sputum sample.
- Rifampicin resistance detected by Xpert MTB/RIF Ultra test conducted on the screening sputum.
- Chest radiograph consistent with evidence of active TB disease, in the opinion of the investigator.
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- Able to provide a sputum sample.
- Participants of reproductive potential (PORP) must agree to use 2 different approved methods of birth control and continue for 12 weeks after the last dose of quabodepistat (QBS) or the other drugs administered in the trial interventions.
- Willing to have an HIV test unless a prior HIV-positive result can be confirmed.
- Participants living with HIV must be receiving a stable antiretroviral regimen containing dolutegravir, lamivudine or emtricitabine, and tenofovir for at least 3 months before signing informed consent or assent; must have HIV-1 RNA below 200 copies/mL at screening; and must have a CD4 count greater than 100 cells/µL at screening.
Who cannot join
- Known or suspected resistance to any drugs administered in the treatment interventions (bedaquiline [BDQ], pretomanid [PMD], linezolid [LZD], or quabodepistat [QBS]) or the respective drug classes, confirmed by laboratory testing or based on epidemiologic history (e.g., known source case with resistance).
- Prior treatment for drug-resistant TB, except where the study Medical Monitor confirms an adequate washout period for prior medications.
- Clinical evidence of extrapulmonary TB considered severe by the investigator (e.g., pleural, pericardial, miliary, abdominal, urogenital, osteoarticular TB, or TB meningitis).
- Laboratory test results of: ALT or AST >2.5 × ULN; Total bilirubin >1.5 × ULN; eGFR <60 mL/min/1.73 m²; Hemoglobin <8 g/dL; Platelets <100,000 cells/µL; White blood cell count <2.0 × 10⁹/L; Absolute neutrophil count <1,000 cells/µL; and HbA1c >9.0%.
- Pre-existing peripheral neuropathy (Grade ≥1), optic neuritis, or any visual impairment that could prevent reliable monitoring or safety assessments (including but not limited to loss of red-green color discrimination, dense cataracts, optic disc changes, or newly developed central scotomas).
- Co-enrollment in other therapeutic clinical trials. Use of an investigational drug within 90 days preceding trial entry will be assessed case-by-case.
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- QTcF >450 msec (males) or >470 msec (females); atrioventricular block II or III; bifascicular block at screening; current or history of clinically significant ventricular arrhythmias; family history of long QT syndrome or sudden death; or other ECG abnormalities considered clinically significant by the investigator.
- History of, or current, clinically relevant cardiovascular disorder, including heart failure, coronary heart disease, uncontrolled hypertension, arrhythmia, history of aortic aneurysm, or symptoms strongly suggestive of such a problem (e.g., syncope or palpitations), tachyarrhythmia, or status post myocardial infarction.
- Known bleeding disorders or family history of bleeding disorders.
- Any underlying condition that could interfere with assessment of X-ray images, sputum collection, or interpretation of sputum findings, or otherwise compromise participation (e.g., pulmonary silicosis, lung fibrosis, or other lung condition considered severe by the investigator, other than TB).
- Known contraindication, allergy/sensitivity, intolerance, or hypersensitivity to components of trial drugs or their formulations.
- Participants of childbearing potential who are breastfeeding or plan to breastfeed during the trial, have a positive pregnancy test before receiving the first dose of trial intervention, or plan to become pregnant during the trial.
- Positive cocaine or other drugs-of-abuse screen (excluding prescribed stimulants/other prescribed medications and marijuana) at screening may be exclusionary. Detectable alcohol, marijuana, barbiturates, or opiates are not exclusionary if, in the investigator's documented opinion, the participant does not meet DSM-5 TR criteria for moderate-to-severe substance use disorder, does not pose safety/interpretability concerns, and participation is agreed to by the Medical Monitor prior to treatment.
- History of serious mental disorders that, in the opinion of the investigator, would exclude participation.
- Karnofsky score <60 at screening.
- Body mass index (BMI) <16.0 kg/m².
- Evidence of clinically significant metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine (e.g., uncontrolled diabetes), or liver disease (e.g., clinically significant hepatitis B or C disease); malignancy; or other abnormalities that would preclude ability to participate and complete the trial, including a history of tendon disorders or prior tendinopathy/tendon rupture.
- Evidence of pulmonary silicosis, lung fibrosis, or other lung/respiratory condition considered severe by the investigator (other than TB).
- Receiving prohibited medications (see protocol Section 6.6.1) within specified periods or likely to require prohibited concomitant therapy during the trial.
- Significant medical comorbidities that, in the opinion of the investigator, should preclude trial participation.
- Donation of blood or plasma within 30 days prior to dosing.
- Current use of herbal remedies or traditional medicines.
Trial locations and contacts
42 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 10 countries
South Africa13 sites, 12 recruiting
- Recruiting
Brooklyn Chest Hospital
Belville, Western Cape, 7405
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
UCT - Lung Infection and Immunity Unit
Cape Town, Western Cape, 7700
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
UCT Lung Institute
Cape Town, Western Cape, 7700
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Durban, KwaZulu-Natal, 4013
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Synergy Biomed Research Institute
East London, Eastern Cape, 5241
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
The Aurum Institute - Tembisa Hospital Clinical Research Centre
Johannesburg, Gauteng, 1632
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital
Johannesburg, Gauteng, 2092
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,
Johannesburg, Gauteng, 2131
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit
Klerksdorp, North West, 2574
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital
Port Elizabeth, Eastern Cape, 6003
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Withdrawn
Setshaba Research Center
Pretoria, Gauteng, 0152
- Recruiting
The Aurum Institute - Rustenburg
Rustenburg, North West, 0299
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital
Soweto, Gauteng, 1835
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
China9 sites, 9 recruiting
- Recruiting
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, 101100
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, 610041
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
Fuzhou, Fujian, 350008
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, 200433
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518112
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, 430032
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
India4 sites, 4 recruiting
- Not yet recruiting
Indian Council of Medical Research (ICMR) - National Institute for Research in Tuberculosis (NIRT) (Tuberculosis Research Centre)
Chennai, Tamil Nadu, 600031
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
P.D. Hinduja Hospital & Medical Research Centre - MAHIM
Mumbai, Maharashtra, 400016
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
Rajan Babu Institute of Pulmonary Medicine and Tuberculosis (RBIPMT) - RBTB Hospital
New Delhi, National Capital Territory of Delhi, 110009
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
National Institute of Tuberculosis and Respiratory Diseases Hospital (NITRD)
New Delhi, National Capital Territory of Delhi, 110030
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Philippines4 sites, 4 recruiting
- Recruiting
Rafael Lazatin Memorial Medical Center
Angeles City, Pampanga, 2009
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Tropical Disease Foundation
Makati City, National Capital Region, 1772
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Lung Center Of The Philippines
Quezon City, National Capital Region, 1100
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Silang Specialist Medical Center
Silang, Cavite, 4118
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Indonesia3 sites, 3 recruiting
- Not yet recruiting
Rumah Sakit Umum Pusat (RSUP) Dr. Hasan Sadikin
Bandung, West Java, 40161
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
Rumah Sakit Paru Dr. M. Goenawan Partowidigdo (RSPG)
Bogor, West Java, 16750
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
Jakarta Islamic Hospital - Rumah Sakit Islam Jakarta (RSIJ)
Jakarta, Special Capital Region of Jakarta, 10510
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Peru3 sites, 3 recruiting
- Recruiting
Socios en Salud Sucursal Peru
La Molina, Lima region, 15012
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Hospital Sergio E. Bernales
Lima, 15313
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Not yet recruiting
Centro de Investigación del Hospital de Emergencias de Villa el Salvador
Villa El Salvador, Lima region, 15837
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
South Korea3 sites, 3 recruiting
- Recruiting
Pusan National University Hospital
Busan, Pusan-Kwangyokshi, 49241
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, Incheon Metropolitan City, 21431
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
- Recruiting
Asan Medical Center - Pulmonology
Seoul, Seoul Teugbyeolsi, 05505
Otsuka Cell Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Georgia1 site, 1 recruiting
- Recruiting
National Center for Tuberculosis and Lung Disease
Tbilisi, 0101
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Japan1 site, 1 recruiting
- Recruiting
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose, Tokyo, 204-8522
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Moldova1 site, 1 recruiting
- Recruiting
IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology
Chisinau, Chisinau City, MD-2025
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
About this study
Official title: A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or multidrug-resistant pulmonary tuberculosis.
Participants are assigned to 1 of 2 cohorts based on fluoroquinolone susceptibility. In the fluoroquinolone-susceptible cohort, participants are randomized 1:1 to receive either a 4-month experimental regimen of bedaquiline, pretomanid, quabodepistat, and moxifloxacin or a 6-month control regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. In the fluoroquinolone-resistant cohort, participants are randomized 3:1 to receive either a 6-month experimental regimen of bedaquiline, pretomanid, and quabodepistat or a 6-month control regimen of bedaquiline, pretomanid, and linezolid.
A total of approximately 532 participants are planned, including 432 participants in the fluoroquinolone-susceptible cohort and approximately 100 participants in the fluoroquinolone-resistant cohort. The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months post-randomization. Prespecified agency-specific definitions are used for the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events will be confirmed by a blinded Endpoint Adjudication Committee.
Read the detailed description
This Phase 3, randomized, open-label, active-controlled, multicenter trial that evaluates quabodepistat as part of efficacious, shorter duration, less toxic and well tolerated regimens for participants with drug-resistant (DR) tuberculosis (TB).
Participants are assigned to one of two cohorts based on fluoroquinolone susceptibility determined using a rapid molecular test at screening. Approximately 432 participants with fluoroquinolone-susceptible tuberculosis are randomized in a 1:1 ratio to receive either the 4-month experimental BPaQM regimen or the 6-month active-control BPaLM regimen. Approximately 100 participants with fluoroquinolone-resistant tuberculosis are randomized in a 3:1 ratio to receive either the 6-month experimental BPaQ regimen or the 6-month active-control BPaL regimen. A total of approximately 532 participants are planned. Randomization is stratified by country and disease severity, which is based on chest radiograph findings and baseline bacterial burden.
Enrollment may be managed to maintain an appropriate distribution across disease-severity categories. Enrollment of participants living with HIV may be restricted in certain countries because of applicable regulatory or country-specific requirements.
If fluoroquinolone susceptibility results from the screening molecular test and phenotypic susceptibility testing of trial-entry specimens are discordant, all available microbiological and clinical information is considered. Discordant results are resolved using protocol-defined methods and World Health Organization guidance, and sequencing may be used to support the interpretation. A change in cohort or treatment regimen occurs only when supported by the available evidence and protocol-defined medical review.
Participants may be classified as late exclusions if cultures from trial-entry sputum fail to grow Mycobacterium tuberculosis, rifampicin resistance is not confirmed by Xpert MTB/RIF Ultra testing of the trial-entry isolate, or the trial-entry isolate is confirmed to be resistant to an allocated trial drug other than moxifloxacin. Participants classified as late exclusions discontinue trial treatment and are referred for appropriate treatment in accordance with the protocol.
The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months after randomization. Prespecified definitions will be applied to the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events are reviewed by a blinded Endpoint Adjudication Committee.
Participants are followed through Week 68, approximately 16 months after randomization. A Week 72 contact or visit may be conducted for participants with ongoing adverse events or when additional follow-up is required for relapse, microbiological recurrence, or another protocol-defined assessment.
- Being tested
- Bedaquiline, Quabodepistat, Pretomanid, Moxifloxacin, Linezolid
- Keywords
- Quabodepistat, Bedaquiline, Pretomanid, Linezolid, Moxifloxacin, Shortened TB treatment, OPC-167832, RR-TB, MDR-TB, fluoroquinolone-susceptible, fluoroquinolone-resistant
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BedaquilineDrug
Also called BDQ; B
In the BPaQM and BPaQ experimental arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 100 mg once daily for 15 weeks in the BPaQM arm or 24 weeks in the BPaQ arm. In the BPaLM and BPaL control arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 24 weeks.
QuabodepistatDrug
Also called OPC-167832; QBS; Q
Quabodepistat 30 mg administered orally once daily under fed conditions, during or immediately after a meal. Quabodepistat is administered for 4 months, with a target of 120 treatment days, in the BPaQM arm and for 6 months, with a target of 180 treatment days, in the BPaQ arm.
PretomanidDrug
Also called PMD; Pa
Pretomanid 200 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM, BPaQ, and BPaL arms.
MoxifloxacinDrug
Also called MFX; M
Moxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm.
LinezolidDrug
Also called LZD; L
Linezolid 600 mg administered orally once daily for 6 months in the BPaLM and BPaL arms. Protocol-defined dose reduction to 300 mg once daily, temporary interruption, or discontinuation may be permitted to manage significant toxicity after consultation with the medical monitor.
| Study group | Role | What they receive |
|---|---|---|
| BPaQM for fluoroquinolone-susceptible RR/MDR-TB | Experimental | Bedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 15 weeks; pretomanid 200 mg orally once daily; quabodepistat 30 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 4 months, with a target of 120 treatment days. Receives: Drug: Bedaquiline; Drug: Quabodepistat; Drug: Pretomanid; Drug: Moxifloxacin |
| BPaLM for fluoroquinolone-susceptible RR/MDR-TB | Active comparator | Bedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; linezolid 600 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity. Receives: Drug: Bedaquiline; Drug: Pretomanid; Drug: Moxifloxacin; Drug: Linezolid |
| BPaQ for fluoroquinolone-resistant RR/MDR-TB | Experimental | Bedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 24 weeks; pretomanid 200 mg orally once daily; and quabodepistat 30 mg orally once daily. The planned regimen duration is 6 months, with a target of 180 treatment days. Receives: Drug: Bedaquiline; Drug: Quabodepistat; Drug: Pretomanid |
| BPaL for fluoroquinolone-resistant RR/MDR-TB | Active comparator | Bedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; and linezolid 600 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity. Receives: Drug: Bedaquiline; Drug: Pretomanid; Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with an unfavorable outcome by 12 months post-randomization.
Percentage of participants with at least one unfavorable outcome by 12 months post-randomization. All definitions include all-cause death, treatment failure, and failure to achieve sputum culture conversion by end of treatment leading to antimycobacterial therapy change. FDA-aligned: also includes tolerability-driven regimen changes and microbiological recurrence (relapse or reinfection); conversion requires two negative cultures ≥28 days apart with subsequent culture negativity. EMA-aligned: excludes tolerability-driven regimen changes and reinfection; conversion requires two negative cultures ≥1 week apart without an intervening positive culture. Other-Regulator: includes tolerability-driven regimen changes, excludes reinfection, and applies the EMA conversion criterion. All events are confirmed by a blinded Endpoint Adjudication Committee. These are prespecified operational definitions of one primary efficacy endpoint, not co-primary endpoints.
Measured: From randomization through 12 months post-randomization.
Proportion of participants with significant treatment-emergent adverse events (TEAEs) during treatment and through 2 weeks after treatment.
Percentage of participants experiencing at least one of the following during the treatment period and through two weeks after the end of treatment:
- A Grade 3 or higher treatment-emergent adverse event.
- A serious treatment-emergent adverse event.
- A treatment-emergent adverse event leading to dose reduction.
- A treatment-emergent adverse event leading to discontinuation of study intervention.
Each participant will be counted once for the composite endpoint, regardless of the number or type of qualifying events experienced.
Measured: From the first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Secondary outcomes (14)
Time to first unfavorable outcome.
Time from randomization to the first occurrence of an unfavorable outcome. The FDA-aligned, EMA-aligned, and Other-Regulator definitions will be evaluated separately using the applicable prespecified definition. All unfavorable outcome events will be confirmed by the blinded Endpoint Adjudication Committee.
Measured: From randomization through 12 months post-randomization.
Time to sputum culture conversion.
Time from randomization to sputum culture conversion. The FDA-aligned definition requires the first of 2 consecutive negative sputum cultures collected at least 28 days apart, with subsequent culture negativity during treatment. The EMA-aligned and Other-Regulator definitions require the first of 2 consecutive negative sputum cultures collected at least 1 week apart, without an intervening positive culture. Each definition will be evaluated separately.
Measured: From randomization through the end of treatment, up to approximately 28 weeks.
Proportion of participants with significant TEAEs related to quabodepistat or linezolid.
Percentage of participants experiencing at least one Grade 3 or higher treatment-emergent adverse event, serious treatment-emergent adverse event, treatment-emergent adverse event leading to dose reduction, or treatment-emergent adverse event leading to discontinuation that is assessed as related to quabodepistat or linezolid. Each participant will be counted once for the composite measure, regardless of the number or type of qualifying events.
Measured: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with adverse events of special interest.
Percentage of participants experiencing at least one protocol-defined adverse event of special interest during treatment or within 2 weeks after treatment. Adverse events of special interest include QT interval prolongation, hepatotoxicity, peripheral neuropathy, optic neuritis, and myelotoxicity. Myelotoxicity includes Grade 3 or higher anemia, neutropenia, or thrombocytopenia.
Measured: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with treatment-emergent adverse events through Week 68.
Percentage of participants experiencing at least one treatment-emergent adverse event from the first dose of trial intervention through Week 68 post-randomization.
Measured: From first dose through Week 68 post-randomization.
Proportion of participants with Grade 3 or higher or serious TEAEs through Week 68.
Percentage of participants experiencing at least one Grade 3 or higher treatment-emergent adverse event or serious treatment-emergent adverse event from the first dose of trial intervention through Week 68 post-randomization. Each participant will be counted once for the composite measure, regardless of the number or type of qualifying events.
Measured: From first dose through Week 68 post-randomization.
Proportion of treatment time without adverse events.
Proportion of each participant's assigned treatment period during which the participant is free from adverse events. Results will be summarized by treatment arm.
Measured: During the assigned treatment period, approximately 4 or 6 months.
Proportion of participants lost to follow-up.
Percentage of participants who meet the protocol-defined criteria for lost to follow-up through Week 68 post-randomization.
Measured: From randomization through Week 68.
Proportion of participants with tuberculosis-related death.
Percentage of participants who die from a cause adjudicated as related to tuberculosis through Week 68 post-randomization. Tuberculosis-related deaths will be confirmed by the blinded Endpoint Adjudication Committee.
Measured: From randomization through Week 68.
Proportion of participants with sputum culture conversion at Week 8.
Percentage of participants who achieve sputum culture conversion by Week 8. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator sputum culture conversion definitions.
Measured: At Week 8 post-randomization.
Proportion of participants with sputum culture conversion at end of treatment.
Percentage of participants who achieve sputum culture conversion by the end of the assigned treatment period. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator sputum culture conversion definitions.
Measured: At the end of treatment, approximately 4 months for BPaQM and 6 months for BPaLM, BPaQ, and BPaL.
Proportion of participants with microbiological relapse by 12 months post-randomization.
Percentage of participants with microbiological recurrence during follow-up caused by the same Mycobacterium tuberculosis complex strain identified at baseline, as determined by whole-genome sequencing. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Measured: From the end of treatment through 12 months post-randomization.
Proportion of participants with reinfection by 12 months post-randomization.
Percentage of participants with microbiological recurrence during follow-up caused by a Mycobacterium tuberculosis complex strain different from the strain identified at baseline, as determined by whole-genome sequencing. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Measured: From the end of treatment through 12 months post-randomization.
Plasma concentrations of study drugs in quabodepistat-containing regimens.
Plasma concentrations of quabodepistat, pretomanid, bedaquiline, the bedaquiline M2 metabolite, and moxifloxacin at protocol-specified sampling visits in participants assigned to the BPaQM or BPaQ experimental arms. Moxifloxacin concentrations will apply only to participants assigned to BPaQM.
Measured: During treatment at protocol-specified pharmacokinetic sampling visits, through approximately Week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start16 Oct 2025
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rifampicin-Resistant Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has two parallel cohorts based on fluoroquinolone sensitivity status, each with an experimental arm and a control arm.
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simbarashe G Takuva, MD, MSc., Study director, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209761
- Sponsor's protocol ID
- 323-201-00013
- Other IDs
- jRCT2031260045
- Acronym
- QUANTUM-TB
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT07209761
- Acronym / sponsor ID
- QUANTUM-TB / 323-201-00013
- Keywords
- Quabodepistat, Bedaquiline, Pretomanid, Linezolid, Moxifloxacin, Shortened TB treatment, OPC-167832, RR-TB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or multidrug-resistant pulmonary tuberculosis.
Participants are assigned to 1 of 2 cohorts based on fluoroquinolone susceptibility. In the fluoroquinolone-susceptible cohort, participants are randomized 1:1 to receive either a 4-month experimental regimen of bedaquiline, pretomanid, quabodepistat, and moxifloxacin or a 6-month control regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. In the fluoroquinolone-resistant cohort, participants are randomized 3:1 to receive either a 6-month experimental regimen of bedaquiline, pretomanid, and quabodepistat or a 6-month control regimen of bedaquiline, pretomanid, and linezolid.
A total of approximately 532 participants are planned, including 432 participants in the fluoroquinolone-susceptible cohort and approximately 100 participants in the fluoroquinolone-resistant cohort. The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months post-randomization. Prespecified agency-specific definitions are used for the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events will be confirmed by a blinded Endpoint Adjudication Committee.
Detailed description
This Phase 3, randomized, open-label, active-controlled, multicenter trial that evaluates quabodepistat as part of efficacious, shorter duration, less toxic and well tolerated regimens for participants with drug-resistant (DR) tuberculosis (TB).
Participants are assigned to one of two cohorts based on fluoroquinolone susceptibility determined using a rapid molecular test at screening. Approximately 432 participants with fluoroquinolone-susceptible tuberculosis are randomized in a 1:1 ratio to receive either the 4-month experimental BPaQM regimen or the 6-month active-control BPaLM regimen. Approximately 100 participants with fluoroquinolone-resistant tuberculosis are randomized in a 3:1 ratio to receive either the 6-month experimental BPaQ regimen or the 6-month active-control BPaL regimen. A total of approximately 532 participants are planned. Randomization is stratified by country and disease severity, which is based on chest radiograph findings and baseline bacterial burden.
Enrollment may be managed to maintain an appropriate distribution across disease-severity categories. Enrollment of participants living with HIV may be restricted in certain countries because of applicable regulatory or country-specific requirements.
If fluoroquinolone susceptibility results from the screening molecular test and phenotypic susceptibility testing of trial-entry specimens are discordant, all available microbiological and clinical information is considered. Discordant results are resolved using protocol-defined methods and World Health Organization guidance, and sequencing may be used to support the interpretation. A change in cohort or treatment regimen occurs only when supported by the available evidence and protocol-defined medical review.
Participants may be classified as late exclusions if cultures from trial-entry sputum fail to grow Mycobacterium tuberculosis, rifampicin resistance is not confirmed by Xpert MTB/RIF Ultra testing of the trial-entry isolate, or the trial-entry isolate is confirmed to be resistant to an allocated trial drug other than moxifloxacin. Participants classified as late exclusions discontinue trial treatment and are referred for appropriate treatment in accordance with the protocol.
The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months after randomization. Prespecified definitions will be applied to the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events are reviewed by a blinded Endpoint Adjudication Committee.
Participants are followed through Week 68, approximately 16 months after randomization. A Week 72 contact or visit may be conducted for participants with ongoing adverse events or when additional follow-up is required for relapse, microbiological recurrence, or another protocol-defined assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study has two parallel cohorts based on fluoroquinolone sensitivity status, each with an experimental arm and a control arm.
| Arm | Type | Receives |
|---|---|---|
| BPaQM for fluoroquinolone-susceptible RR/MDR-TB | Experimental | Drug: Bedaquiline, Drug: Quabodepistat, Drug: Pretomanid, Drug: MoxifloxacinBedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 15 weeks; pretomanid 200 mg orally once daily; quabodepistat 30 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 4 months, with a target of 120 treatment days. |
| BPaLM for fluoroquinolone-susceptible RR/MDR-TB | Active comparator | Drug: Bedaquiline, Drug: Pretomanid, Drug: Moxifloxacin, Drug: LinezolidBedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; linezolid 600 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity. |
| BPaQ for fluoroquinolone-resistant RR/MDR-TB | Experimental | Drug: Bedaquiline, Drug: Quabodepistat, Drug: PretomanidBedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 24 weeks; pretomanid 200 mg orally once daily; and quabodepistat 30 mg orally once daily. The planned regimen duration is 6 months, with a target of 180 treatment days. |
| BPaL for fluoroquinolone-resistant RR/MDR-TB | Active comparator | Drug: Bedaquiline, Drug: Pretomanid, Drug: LinezolidBedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; and linezolid 600 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide written informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the investigator, to comply with all trial requirements (if under 18 years of age: participant assent AND parent/legal guardian consent are required).
- Male or female participants aged ≥14 years at screening.
- Body weight ≥30.0 kg at screening.
- Documented pulmonary TB: Mycobacterium tuberculosis (Mtb) confirmed by Xpert MTB/RIF Ultra with a semi-quantitative result of "low," "medium," or "high" on the screening sputum sample.
- Rifampicin resistance detected by Xpert MTB/RIF Ultra test conducted on the screening sputum.
Key exclusion criteria (22 listed)
- Known or suspected resistance to any drugs administered in the treatment interventions (bedaquiline [BDQ], pretomanid [PMD], linezolid [LZD], or quabodepistat [QBS]) or the respective drug classes, confirmed by laboratory testing or based on epidemiologic history (e.g., known source case with resistance).
- Prior treatment for drug-resistant TB, except where the study Medical Monitor confirms an adequate washout period for prior medications.
- Clinical evidence of extrapulmonary TB considered severe by the investigator (e.g., pleural, pericardial, miliary, abdominal, urogenital, osteoarticular TB, or TB meningitis).
- Laboratory test results of: ALT or AST >2.5 × ULN; Total bilirubin >1.5 × ULN; eGFR <60 mL/min/1.73 m²; Hemoglobin <8 g/dL; Platelets <100,000 cells/µL; White blood cell count <2.0 × 10⁹/L; Absolute neutrophil count <1,000 cells/µL; and HbA1c >9.0%.
- Pre-existing peripheral neuropathy (Grade ≥1), optic neuritis, or any visual impairment that could prevent reliable monitoring or safety assessments (including but not limited to loss of red-green color discrimination, dense cataracts, optic disc changes, or newly developed central scotomas).
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 |
|---|---|---|
| BedaquilineAlso: BDQ; BIn the BPaQM and BPaQ experimental arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 100 mg once daily for 15 weeks in the BPaQM arm or 24 weeks in the BPaQ arm. In the BPaLM and BPaL control arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 24 weeks. | Drug | BPaL for fluoroquinolone-resistant RR/MDR-TB, BPaLM for fluoroquinolone-susceptible RR/MDR-TB, BPaQ for fluoroquinolone-resistant RR/MDR-TB, BPaQM for fluoroquinolone-susceptible RR/MDR-TB |
| QuabodepistatAlso: OPC-167832; QBS; QQuabodepistat 30 mg administered orally once daily under fed conditions, during or immediately after a meal. Quabodepistat is administered for 4 months, with a target of 120 treatment days, in the BPaQM arm and for 6 months, with a target of 180 treatment days, in the BPaQ arm. | Drug | BPaQ for fluoroquinolone-resistant RR/MDR-TB, BPaQM for fluoroquinolone-susceptible RR/MDR-TB |
| PretomanidAlso: PMD; PaPretomanid 200 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM, BPaQ, and BPaL arms. | Drug | BPaL for fluoroquinolone-resistant RR/MDR-TB, BPaLM for fluoroquinolone-susceptible RR/MDR-TB, BPaQ for fluoroquinolone-resistant RR/MDR-TB, BPaQM for fluoroquinolone-susceptible RR/MDR-TB |
| MoxifloxacinAlso: MFX; MMoxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm. | Drug | BPaLM for fluoroquinolone-susceptible RR/MDR-TB, BPaQM for fluoroquinolone-susceptible RR/MDR-TB |
| LinezolidAlso: LZD; LLinezolid 600 mg administered orally once daily for 6 months in the BPaLM and BPaL arms. Protocol-defined dose reduction to 300 mg once daily, temporary interruption, or discontinuation may be permitted to manage significant toxicity after consultation with the medical monitor. | Drug | BPaL for fluoroquinolone-resistant RR/MDR-TB, BPaLM for fluoroquinolone-susceptible RR/MDR-TB |
Primary outcome
Proportion of participants with an unfavorable outcome by 12 months post-randomization.
Time frame: From randomization through 12 months post-randomization.
Percentage of participants with at least one unfavorable outcome by 12 months post-randomization. All definitions include all-cause death, treatment failure, and failure to achieve sputum culture conversion by end of treatment leading to antimycobacterial therapy change. FDA-aligned: also includes tolerability-driven regimen changes and microbiological recurrence (relapse or reinfection); conversion requires two negative cultures ≥28 days apart with subsequent culture negativity. EMA-aligned: excludes tolerability-driven regimen changes and reinfection; conversion requires two negative cultures ≥1 week apart without an intervening positive culture. Other-Regulator: includes tolerability-driven regimen changes, excludes reinfection, and applies the EMA conversion criterion. All events are confirmed by a blinded Endpoint Adjudication Committee. These are prespecified operational definitions of one primary efficacy endpoint, not co-primary endpoints.
Proportion of participants with significant treatment-emergent adverse events (TEAEs) during treatment and through 2 weeks after treatment.
Time frame: From the first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Percentage of participants experiencing at least one of the following during the treatment period and through two weeks after the end of treatment: 1. A Grade 3 or higher treatment-emergent adverse event. 2. A serious treatment-emergent adverse event. 3. A treatment-emergent adverse event leading to dose reduction. 4. A treatment-emergent adverse event leading to discontinuation of study intervention. Each participant will be counted once for the composite endpoint, regardless of the number or type of qualifying events experienced.
14 secondary outcomes
Time to first unfavorable outcome.
Time frame: From randomization through 12 months post-randomization.
Time to sputum culture conversion.
Time frame: From randomization through the end of treatment, up to approximately 28 weeks.
Proportion of participants with significant TEAEs related to quabodepistat or linezolid.
Time frame: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with adverse events of special interest.
Time frame: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with treatment-emergent adverse events through Week 68.
Time frame: From first dose through Week 68 post-randomization.
Proportion of participants with Grade 3 or higher or serious TEAEs through Week 68.
Time frame: From first dose through Week 68 post-randomization.
Proportion of treatment time without adverse events.
Time frame: During the assigned treatment period, approximately 4 or 6 months.
Proportion of participants lost to follow-up.
Time frame: From randomization through Week 68.
Proportion of participants with tuberculosis-related death.
Time frame: From randomization through Week 68.
Proportion of participants with sputum culture conversion at Week 8.
Time frame: At Week 8 post-randomization.
Proportion of participants with sputum culture conversion at end of treatment.
Time frame: At the end of treatment, approximately 4 months for BPaQM and 6 months for BPaLM, BPaQ, and BPaL.
Proportion of participants with microbiological relapse by 12 months post-randomization.
Time frame: From the end of treatment through 12 months post-randomization.
Proportion of participants with reinfection by 12 months post-randomization.
Time frame: From the end of treatment through 12 months post-randomization.
Plasma concentrations of study drugs in quabodepistat-containing regimens.
Time frame: During treatment at protocol-specified pharmacokinetic sampling visits, through approximately Week 15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Otsuka Clinical Trials WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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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.
Simbarashe G Takuva, MD, MSc. study director
Study Sponsor
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bedaquiline, Quabodepistat and Pretomanid in people with Rifampicin-Resistant Pulmonary Tuberculosis and Multidrug-Resistant Pulmonary Tuberculosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 42 sites in 10 countries.
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 10 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in South Africa, China, India, Philippines, Indonesia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (+1 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with an unfavorable outcome by 12 months post-randomization. (time frame: From randomization through 12 months post-randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.