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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)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Chest Hospital, Capital Medical University
RECRUITING
Beijing
Changsha Central Hospital
RECRUITING
Changsha
Public Health Clinical Center of Chengdu
RECRUITING
Chengdu
Shandong Public Health Clinical Center
RECRUITING
Jinan
The Second Hospital of Nanjing
RECRUITING
Nanjing
Huashan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
Wuhan Pulmonary Hospital
RECRUITING
Wuhan
Time Frame
Start Date:2025-09-19
Estimated Completion Date:2026-09-04
Participants
Target number of participants:60
Treatments
Experimental: Group A: BJLLfx(M)/C
Bedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C)~Patients will take medications for 8 consecutive weeks.~Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）.
Experimental: Group B: BJLLfx(M)/C
Bedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C).~Patients will take medications for 8 consecutive weeks.~Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）.
Active_comparator: Group C: BDLLfx/C
Bedaquiline (B) and Delamanid (D) and Linezolid (L) and Levofloxacin (Lfx) / Clofazimine (C).~Patients will take medications for 8 consecutive weeks.~Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group C will receive Levofloxacin (Lfx). If fluoroquinolone-resistant, patients in group C will receive Clofazimine (C).