A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets

NCT07170800 | Recruiting Phase 2

• 1 other identifier: JDB-131-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Tuberculosis; Rifampicin-resistant Tuberculosis; Multidrug Resistant Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients with Sputum Culture Conversion (SCC)

  SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative.

  During the 8-week treatment period and after treatment

Secondary Outcomes (24)

• Time to Sputum Culture Conversion (SCC)

  During the 8-week treatment period and after treatment

• Time to positivity (TTP)

  During the 8-week treatment period and after treatment

• Number of Participants With Clinically Significant Abnormality in Vital Signs

  During the 8-week treatment period

• Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values

  During the 8-week treatment period

• Number of Participants With Clinical Significant Abnormality in Laboratory Test

  During the 8-week treatment period

Study Arms (3)

Group A: BJLLfx(M)/C

EXPERIMENTAL

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）.

Drug: JDB0131 100mg

Group B: BJLLfx(M)/C

EXPERIMENTAL

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）.

Drug: JDB0131 200mg

Group C: BDLLfx/C

ACTIVE COMPARATOR

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).

Drug: Delamanid (D)

Interventions

JDB0131 100mg DRUG

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.

Group A: BJLLfx(M)/C

JDB0131 200mg DRUG

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.

Group B: BJLLfx(M)/C

Delamanid (D) DRUG

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.

Group C: BDLLfx/C

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Myocardial infarction;
• Heart surgery or coronary revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty);
• Unstable angina;
• Congestive heart failure (New York Heart Association functional class III or IV);
• 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

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

Study Sites (7)

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

MeSH Terms

Conditions

Tuberculosis

Interventions

OPC-67683; Fumigant 93

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 12, 2025
• Study Start: September 19, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

CN (7)