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RECRUITING
NCT07170800
PHASE2

A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets

Sponsor: WestVac Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-09-19

Completion Date

2026-09-04

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

JDB0131 100mg

Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.

DRUG

JDB0131 200mg

Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 200 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.

DRUG

Delamanid (D)

Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. Delamanid (D): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.

Locations (7)

Wuhan Pulmonary Hospital

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Public Health Clinical Center of Chengdu

Chengdu, Sichuan, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

Huashan Hospital Fudan University

Shanghai, China