Health Trials

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

ConditionsSystemic Sclerosis Associated Interstitial Lung DiseaseRheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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)

Eligibility criteria

Qualifiers

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 classification;

Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening.

Disqualifiers

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;

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;

Trial design

Treatments tested in this trial

  • GenSci048
  • GenSci048 placebo

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

West China Hospital

Collaborator

Source ClinicalTrials.gov