JDB0131 tablets for drug-resistant pulmonary TB

A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)

This tests two doses of the experimental tablet JDB0131 versus a delamanid-containing regimen in people aged 14–65 with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis over an 8-week treatment period.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: WestVac Biopharma Co., Ltd. (Industry-sponsored)
• Locations: 7 sites (Wuhan, Hubei and 6 other locations)
• Trial ID: NCT07170800 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open-label, active-controlled Phase 2b trial comparing JDB0131 100 mg and 200 mg tablets with a delamanid-containing regimen given alongside other background TB drugs for 8 weeks. The study enrolls sputum smear–positive patients with at least rifampicin-resistant pulmonary tuberculosis who meet weight and age criteria and who agree to a 7-day washout of prior anti-TB drugs. Key outcomes include bacterial clearance, safety and tolerability, and pharmacokinetic measurements of JDB0131. The trial is led by WestVac Biopharma and is conducted at three hospital sites in China.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–65 years, weighing 40–90 kg, with sputum smear–positive pulmonary TB confirmed at least rifampicin-resistant who can stop other TB drugs for a 7-day washout and agree to required contraception.

Not a fit: Patients with drug-susceptible TB, exclusively extrapulmonary disease, age under 14 or over 65, weight outside 40–90 kg, pregnant people, or those unwilling/unable to stop other TB drugs or use contraception are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, JDB0131 could offer a new oral treatment option that clears infection more quickly or is better tolerated for people with rifampicin-resistant or multidrug-resistant pulmonary TB.

How similar studies have performed: Regimens that include delamanid and bedaquiline have shown promising results in MDR/RR-TB, while JDB0131 is a novel agent with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* Age: 14 years through 65 years of age, male or female
* Weight: 40kg ≤ weight ≤ 90kg
* Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within 3 months before enrollment can be received
* Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
* Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug treatment and complete a 7-day washout period
* Women of reproductive age must agree to use highly effective contraceptive measures throughout the study and for at least 6 months after discontinuation of the drug. Male participants whose partners are women of reproductive age must agree to use appropriate contraceptive methods throughout the study and for at least 6 months after discontinuation of the drug (see protocol Appendix 1)
* Fully understand the purpose and requirements of this trial, voluntarily sign the written informed consent and agree to abide by the relevant provisions of the informed consent

Exclusion Criteria:

* Those who cannot take delamanid, bedaquiline, or linezolid for various reasons
* Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)
* Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks
* History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia
* Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:

  1. Myocardial infarction;
  2. Heart surgery or coronary revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty);
  3. Unstable angina;
  4. Congestive heart failure (New York Heart Association functional class III or IV);
  5. Transient ischemic attack or severe cerebrovascular disease.
* Peripheral neuropathy CTCAE grade 3 or 4; Grade 1 or 2 peripheral neuropathy that the investigator judges may progress/worsen during the study; Patients with optic neuritis
* History of gastrointestinal surgery or resection that may affect the absorption and/or excretion of oral medications
* Patients who are considered by the investigator to be unsuitable for this trial due to unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine metabolic, psychiatric or rheumatic diseases
* History of alcohol dependence or drug abuse within 6 months before screening, the investigator believes that it may affect the safety of the participants and affect the trial compliance
* Patients who have used other clinical trial investigational drugs within 3 months before administration
* Concomitant take drugs that cause bone marrow suppression
* Concomitant take serotonin reuptake inhibitors, tricyclic antidepressants, serotonin, serotonin receptor agonists, and other drugs
* Concomitant take drugs that prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, etc.
* Chronic systemic corticosteroid therapy, cumulative take for more than 4 weeks within 3 months before enrollment
* Allergic to any investigational drug or related substance as confirmed by the researcher's clinical judgment
* Women who have a positive pregnancy test during screening or are breastfeeding
* Patients with hepatitis B virus (HBV) positive results (HBsAg, HBeAg, and HBcAb); positive hepatitis C virus (HCV) antibodies and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>3 times the upper limit of normal; positive Human Immunodeficiency Virus (HIV) antibody test; positive syphilis antibody test and active syphilis
* Laboratory tests show any of the following:

  1. Hemoglobin \< 80 g/L;
  2. platelets \< 75 ✕ 109 /L;
  3. Aspartate aminotransferase (AST) \> 3 times the upper limit of normal;
  4. Alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
  5. Serum total bilirubin (TBIL) \> 2 times the upper limit of normal;
  6. Serum creatinine (Cr) \> 1.5 times the upper limit of normal;
  7. Serum amylase \> 2 times the upper limit of normal.
* The following abnormalities were found in the electrocardiogram (ECG):

  1. At least twice QTcF intervals \> 450 ms (male) or \> 470 ms (female);
  2. Pathological Q waves (defined as \>40 ms or deep \>0.4-0.5mV);
  3. ECG suggests preexcitation syndrome;
  4. ECG suggests left bundle branch block or right bundle branch block; or second or third degree heart block;
  5. Intraventricular conduction delay with QRS duration \>120ms;
  6. Bradycardia with a sinus rate \< 50 bpm.
* In the investigator's judgment, any condition that affects the subject's compliance with the study protocol, or any serious medical or psychological condition that may affect the interpretation of efficacy and safety data, or any condition that may affect the subject's safety when participating in the trial

Where this trial is running

Wuhan, Hubei and 6 other locations

• Wuhan Pulmonary Hospital — Wuhan, Hubei, China (Recruiting)
• Changsha Central Hospital — Changsha, Hunan, China (Recruiting)
• The Second Hospital of Nanjing — Nanjing, Jiangsu, China (Recruiting)
• Shandong Public Health Clinical Center — Jinan, Shandong, China (Recruiting)
• Public Health Clinical Center of Chengdu — Chengdu, Sichuan, China (Recruiting)
• Beijing Chest Hospital, Capital Medical University — Beijing, China (Recruiting)
• Huashan Hospital Fudan University — Shanghai, China (Not_yet_recruiting)

Conditions Tuberculosis; Multidrug Resistant Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis