Actively Recruiting
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)
Led by WestVac Biopharma Co., Ltd. · Updated on 2026-01-30
60
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different doses of JDB0131 benzenesulfonate tablets compared with delamanid combined with bedaquiline, linezolid, levofloxacin or moxifloxacin, and clofazimine in patients with drug-resistant tuberculosis, including rifampicin-resistant strains. This phase 2b, multicenter, randomized, open-label clinical study aims to assess the efficacy, safety, and how the body processes these treatments over an 8-week period. Participants will be randomly assigned to one of three groups based on their fluoroquinolone resistance status. All groups receive bedaquiline, linezolid, and either levofloxacin or moxifloxacin or clofazimine for 8 consecutive weeks. Two groups receive different doses of JDB0131 (100 mg or 200 mg twice daily), while the third group receives delamanid. Dosages of accompanying drugs are adjusted by body weight and other factors as specified. During the study, participants will undergo regular assessments including sputum culture tests to measure treatment effectiveness, monitoring of vital signs, electrocardiograms, laboratory tests for safety, and pharmacokinetic evaluations to understand drug levels in the body. Adverse events and medication usage will be tracked throughout the 8-week treatment. The primary outcome is the percentage of patients achieving sputum culture conversion during and after treatment.
CONDITIONS
Brief Title
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 65 years, male or female
- Weight between 40 kg and 90 kg
- Clinically confirmed pulmonary tuberculosis with rifampicin-resistant Drug Susceptibility Testing results within 3 months before enrollment
- Positive sputum acid-fast bacilli smear (≥2+ once or ≥1+ twice)
- Agree to stop all anti-tuberculosis drugs and complete a 7-day washout period if currently taking such treatments
- Women of reproductive age must agree to use highly effective contraception during the study and for at least 6 months after stopping the drug; male participants with partners of reproductive age must use appropriate contraception
- Fully understand the trial purpose and voluntarily sign informed consent
You will not qualify if you...
- Unable to take delamanid, bedaquiline, or linezolid for any reason
- Use of delamanid, bedaquiline, or linezolid for over 1 month unless no resistance evidence is provided
- Hematogenously disseminated or severe extrapulmonary tuberculosis, or likely to require surgery within 8 weeks
- History or risk factors for torsades de pointes or long QT syndrome
- Cardiovascular diseases within 6 months, including myocardial infarction, heart surgery, unstable angina, severe heart failure, transient ischemic attack, or severe cerebrovascular disease
- Severe peripheral neuropathy or optic neuritis
- History of gastrointestinal surgery affecting drug absorption or excretion
- Unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine metabolic, psychiatric, or rheumatic diseases
- Alcohol dependence or drug abuse within 6 months affecting safety or compliance
- Use of other investigational drugs within 3 months before administration
- Concurrent use of drugs causing bone marrow suppression or prolonging QT interval
- Chronic systemic corticosteroid therapy exceeding 4 weeks within past 3 months
- Allergy to study drugs or related substances
- Positive pregnancy test or breastfeeding
- Positive tests for hepatitis B, hepatitis C with elevated liver enzymes, HIV, or active syphilis
- Laboratory abnormalities including low hemoglobin or platelets, elevated liver enzymes, bilirubin, creatinine, or amylase
- ECG abnormalities including prolonged QTcF, pathological Q waves, conduction delays, or bradycardia
- Any condition that may affect study compliance or safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 consecutive weeks
Participants receive one of several drug combination regimens including JDB0131 Benzenesulfonate Tablets or Delamanid along with other medications to treat rifampin-resistant tuberculosis.
Visits during the 8-week treatment period as needed for medication administration and monitoring
Trial Site Locations
Total: 7 locations
1
Wuhan Pulmonary Hospital
Wuhan, Hubei, China
Actively Recruiting
2
Changsha Central Hospital
Changsha, Hunan, China
Actively Recruiting
3
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Actively Recruiting
4
Shandong Public Health Clinical Center
Jinan, Shandong, China
Actively Recruiting
5
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
Actively Recruiting
6
Beijing Chest Hospital, Capital Medical University
Beijing, China
Actively Recruiting
7
Huashan Hospital Fudan University
Shanghai, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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