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

Locations

4
Peking University Third Hospital100191, BeijingBeijing Municipality, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology430022, WuhanHubei, China
Qilu Hospital of Shandong University250063, JinanShandong, China
West China Hospital of Sichuan University610047, ChengduSichuan, China

Sponsors and collaborators

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

West China Hospital

Collaborator

Source ClinicalTrials.gov