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Tests treatment safety and results for Systemic Sclerosis Associated Interstitial Lung Disease
Official title A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
ClinicalTrials.gov ID: NCT06189495
What this study is testing
What is GenSci048?
GenSci048 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic sclerosis associated interstitial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Those who voluntarily sign informed consent and can complete the experiment according to the plan;
- Age 18-75 years old (including upper and lower limits), both male and female;
- Rheumatoid arthritis (RA) diagnosed according to the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR)...
- Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening.
- FVC≥ 40% of the expected value during the screening period;
You likely can't join if
- Allergic to experimental drugs or biological agents; People who have previously known other severe allergic reactions;
- Airway obstruction (FEV1/FVC\<0.7 before bronchodilator use) or other lung abnormalities deemed clinically significant by the investigator or a...
- Those who have received any of the following drugs or treatments :
- Receiving prednisone \>15mg/ day or equivalent dose of glucocorticoid within 2 weeks prior to randomization;
- Receive azathioprine, colchicine, D-penicillamine, sulfasalazine within 8 weeks before randomization;
- received rituximab, tolizumab, nidanib, pirfenidone and other treatments within 6 months before randomization; Abacil, TNF inhibitors and other...
See the full eligibility criteria
- Those who voluntarily sign informed consent and can complete the experiment according to the plan;
- Age 18-75 years old (including upper and lower limits), both male and female;
- Rheumatoid arthritis (RA) diagnosed according to the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) classification, or Systemic sclerosis (SSc) according to the 2013 ACR/EULAR...
- Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening.
- FVC≥ 40% of the expected value during the screening period;
- DLCO (using hemoglobin correction) ≥ 40% of the expected value during the screening period;
- Patients may receive 1 immunosuppressant and must maintain a stable dose for 3 months prior to the first dose and agree to maintain a stable dose for at least 6 months after the first dose;
- people of childbearing age who do not plan to become pregnant or donate sperm/eggs and agree to use reliable contraception during the period of participation in this trial and within 6 months after the last dosing.
- Allergic to experimental drugs or biological agents; People who have previously known other severe allergic reactions;
- Airway obstruction (FEV1/FVC\<0.7 before bronchodilator use) or other lung abnormalities deemed clinically significant by the investigator or a history of asthma;
- Those who have received any of the following drugs or treatments :
- Receiving prednisone \>15mg/ day or equivalent dose of glucocorticoid within 2 weeks prior to randomization;
- Receive azathioprine, colchicine, D-penicillamine, sulfasalazine within 8 weeks before randomization;
- received rituximab, tolizumab, nidanib, pirfenidone and other treatments within 6 months before randomization; Abacil, TNF inhibitors and other biologic agents were received within 3 months before randomization...
- Combined with other rheumatic diseases, such as idiopathic inflammatory myopathy, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitis;
- Significant pulmonary hypertension, meeting one of the following conditions:
- Previous clinical or echocardiographic evidence of significant right heart failure;
- Right cardiac catheterization showed cardiac index ≤ 2 l/min/m2;
- Pulmonary hypertension requiring extraenteral treatment with eprostol/traprostacycline;
- There are active bleeding diseases of internal organs, or have a serious bleeding tendency (such as hemophilia, etc.), or are undergoing anticoagulant treatment;
- There are infections requiring systemic drug control within 7 days prior to screening; Diagnosed with active tuberculosis infection;
- Have received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period; Vaccination against COVID-19 within 2 weeks prior to screening;
- Previous stem cell therapy or any type of bone marrow transplant; Previous solid organ transplants; Long-term systemic use of glucocorticoids for other diseases;
- There is a history of serious immunodeficiency, or other acquired or congenital immunodeficiency diseases;
- History of malignant tumor within 5 years before screening;
- Recipients of kidney dialysis;
- Presence of the following clinically significant heart diseases:
- A history of chronic congestive heart failure, NYHA level IV; History of cardiac ejection fraction (EF) \< 30% by echocardiography;
- Myocardial infarction, acute coronary syndrome, viral myocarditis, and pulmonary embolism occurred within 3 months; Coronary revascularization was performed within 6 months.
- There are severe arrhythmias that require Class Ia or III antiarrhythmic drugs; Arrhythmias with diseased sinus syndrome, grade II type II or grade III atrioventricular block, and no pacemaker implanted;
- During the screening period, electrocardiogram indicated QTcF interval ≥ 480 ms (according to Fridericia correction formula, where QTcF=QT/RR\^0.33), or a history of prolonged QTc interval;
- There are the following abnormalities in the laboratory test values during the screening period:
- White blood cell count \<3×109/L, neutrophil count \<1.5×109/L;
- PLT\<75×109/L;
- Total bilirubin \>1.5×ULN, alanine aminotransferase (ALT) \>3×ULN, aspartate aminotransferase (AST) \>3×ULN;
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2;
- History or current positive results of serum virology tests:
- hepatitis B surface antigen positive, or hepatitis B core antibody positive and HBV-DNA higher than the detection limit;
- Hepatitis C virus (HCV) antibody positive;
- Positive for human immunodeficiency virus (HIV) antibodies;
- Those who are positive for treponema pallidum antibodies and need treatment for syphilis infection.
- Received treatment with any investigational drug or medical device in a clinical trial within 3 months prior to screening;
- Pregnancy test positive during screening period; Lactating women;
- The investigator assessed those who had other factors that made them unsuitable for participation in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Jinan, Shandong, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Jinan, Shandong, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.