A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease

A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Tetrandrine Tablets in Treating Interstitial Lung Disease Related to Connective Tissue Disease

This study evaluates the efficacy and safety of tetrandrine tablets (60 mg, three times daily) compared to placebo in adult patients with connective tissue disease-related interstitial lung disease. Patients receive standard treatment (glucocorticoids and immunosuppressants) alongside the study drug or placebo for 24 weeks. The study measures changes in lung function, inflammatory markers, lung imaging, quality of life, and safety outcomes.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease (ILD); Connective Tissue Disease-associated Interstitial Lung Disease
• Intervention / Treatment: Drug: Tetrandrine Tablets; Drug: Placebo

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled study enrolls 100 adults with connective tissue disease-related interstitial lung disease. Patients are randomized 1:1 to receive tetrandrine tablets (60 mg TID) or placebo for 24 weeks, alongside standard treatment. The primary outcome is the change in forced vital capacity (FVC) at 24 weeks. Secondary outcomes include changes in serum inflammatory markers (TGF-β1, KL6, TNF-α, IL-6), lung HRCT scores, other Lung function parameters (TLC, VC, DLCO, PaO2), St. George's Respiratory Questionnaire (SGRQ) score, safety parameters, and all-cause mortality. Visits occur at weeks 4, 8, 12, and 24 for efficacy and safety assessments.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Zhang Jing; Phone Number: +86-156119633822; Email: jiaqi@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who voluntarily participate and sign the informed consent form
• Male or female patients aged 18-80 years (inclusive)
• Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening
• FVC ≥40% of predicted value at screening
• Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women >50 years with amenorrhea for >1 year, or surgically sterilized women)
• Patients on stable doses of prednisone (≤20 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period

Exclusion Criteria:

• Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening
• Diabetes with fasting blood glucose greater than 11.1 mmol per L
• Resting arterial oxygen partial pressure less than 50 mmHg
• Active peptic ulcers or bleeding disorders
• Tumors with expected survival less than 1 year
• Active pulmonary tuberculosis
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times the upper limit of normal (ULN) or higher, or ALT or AST 3 times ULN or higher with total bilirubin 2 times ULN or higher
• Creatinine clearance less than 30 mL per min (per Cockcroft-Gault formula) or patients receiving dialysis
• Known allergy to tetrandrine or its excipients
• Severe psychological, mental, cognitive, or intellectual impairments that may affect compliance
• Pregnant or breastfeeding women, or those planning pregnancy within 3 months after the last study drug dose
• Participation in another clinical trial within 3 months before screening
• Patients deemed unsuitable for the study by the investigator
• Clinically significant environmental exposure history that may cause pulmonary fibrosis (e.g., amiodarone, asbestos, beryllium, radiation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tetrandrine Group; Participants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).	Drug: Tetrandrine Tablets; 60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants
Placebo Comparator: Placebo Group; Participants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).	Drug: Placebo; Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Vital Capacity (FVC)	Change in forced vital capacity (FVC) expressed in liters (L) of predicted normal value, measured using a pulmonary function testing device in accordance with ATS/ERS standards at a central facility. Units: Absolute value（L）	Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level	Serum TGF-β1 levels measured via fully automated analyzer. Units: ng/mL	Baseline to 24 weeks
Change in Serum Krebs von den Lungen-6 (KL6) Level	Serum KL6 levels measured via fully automated analyzer. Units: U/mL	Baseline to 24 weeks
Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level	Serum TNF-α levels measured via fully automated analyzer. Units: pg/mL	Baseline to 24 weeks
Change in Serum Interleukin-6 (IL-6) Level	Serum IL-6 levels measured via fully automated analyzer. Units: pg/mL	Baseline to 24 weeks
Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score	Semi-quantitative scoring of HRCT patterns (reticulation, ground-glass opacity, patchy/consolidation, honeycombing) across 6 predefined lung layers. Each pattern scored 0 (absent) to 4 (>75% involvement); total score summed (maximum 96). Higher scores indicate worse outcome (greater lung involvement). Units: Score (0-96)	Baseline to 24 weeks
Change in Total Lung Capacity (TLC)	TLC measured via body plethysmography (ATS/ERS standards) at central facility. Units: Absolute value（L）	Baseline to 24 weeks
Change in Vital Capacity (VC)	VC measured via spirometry (ATS/ERS standards) at central facility. Units: Absolute value（L）	Baseline to 24 weeks
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	Single-breath DLCO (hemoglobin-corrected) measured via ATS/ERS standards at central facility.	Units: Absolute value（L）
Change in Arterial Partial Pressure of Oxygen (PaO2)	PaO2 from arterial blood gas (at rest, room air). Units: mmHg	Baseline to 24 weeks
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score	Change in total score from Chinese-validated SGRQ (self-administered, 3-month recall), assessing respiratory health-related quality of life across Symptoms, Activity, and Impacts domains (weighted). Scores range from 0 (no impairment/best quality of life) to 100 (maximum impairment/worst quality of life). Higher scores indicate worse outcome. Units: Score (0-100)	Baseline to 24 weeks
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0	Incidence of treatment-related adverse events (any untoward event post-randomization), graded by CTCAE v5.0 (coded via MedDRA). Includes abnormalities in hematology, chemistry, urinalysis, liver/kidney function. Units: Number of cases	Baseline to 24 weeks
Number of Participants with Treatment-Emergent Serious Adverse Events	Incidence of serious adverse events as assessed by CTCAE v5.0. Units: Number of cases	Baseline to 24 weeks
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG)	Incidence of clinically significant ECG abnormalities (e.g., QTc prolongation) from 12-lead ECGs. Units: Number of cases	Baseline to 24 weeks
Number of Participants with All-Cause Mortality	Number and percentage of participants who died from any cause during the study period (all-cause mortality), ascertained via follow-up and vital status checks. Units: Number of cases	Baseline to 24 weeks

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Function; Inflammatory Markers; Interstitial Lung Disease; Tetrandrine; Connective Tissue Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Skin and Connective Tissue Diseases; Lung Diseases, Interstitial; Connective Tissue Diseases; tetrandrine
• Other Study ID Numbers: V1.5/2024.11.08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No