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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GenSci048

    Drug

    1\. Dosage: 300 mg.2. Duration of administration: All subjects received one dose of Genakumab injection every 4 weeks according to their group.The dose was injected subcutaneously.3. Course of administration: Phase I subjects were treated with Genakumab injection until the end of the study or the occurrence of the drug.Tolerable toxicity or investigator-assessed efficacy (whichever occurs first); The phase 2 randomized double-blind treatment period was 24 weeks, with a total of 6 administration times. After the randomized double-blind treatment period, an open-label treatment period was entered, and all subjects will receive Genakumab injection 300 mg Q4W until the end of the study or the occurrence of intolerable toxicity or poor efficacy assessed by the investigators (whichever occurs first).4. Administration method: subcutaneous injection; The injection site is the abdomen (3 cm away from the navel

  • GenSci048 placebo

    Drug

    1\. Dosage: 300 mg.2. Duration of administration: All subjects received one dose of placebo every 4 weeks according to their group The dose was injected subcutaneously.3. Course of administration: Phase I subjects were treated with placebo until the end of the study or the occurrence of the drug.Tolerable toxicity or investigator-assessed efficacy (whichever occurs first); The phase 2 randomized double-blind treatment period was 24 weeks, with a total of 6 administration times. After the randomized double-blind treatment period, an open-label treatment period was entered, and all subjects will receive placebo 300 mg Q4W until the end of the study or the occurrence of intolerable toxicity or poor efficacy assessed by the investigators (whichever occurs first). 4\. Administration method: subcutaneous injection; The injection site is the abdomen (3 cm away from the navel)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: GenSci048Experimental treatment 1 intervention
Group B: GenSci048 placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lung function assessment:Subjects' lung function was assessed by FVC .

Time frame
FVC will be evaluated simultaneously during the screening period, 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, and once every 24 weeks thereafter, From baseline up to 2 years
2

Lung function assessment:Subjects' lung function was assessed by DLCO.

Time frame
DLCO will be evaluated simultaneously during the screening period, 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, and once every 24 weeks thereafter, From baseline up to 2 years，early withdrawal/termination of treatment, and when the investigator deems
3

tLung function assessment:Visual simulation score was used to evaluate Physician's Global Asseessment（PGA）

Time frame
"Lung function assessment:The PGA is evaluated during the screening period and once every 12 weeks .From baseline up to 2 years.
4

Safety evaluation indicator：Adverse Events

Time frame
From baseline up to approximately 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

West China Hospital

Collaborator

Source ClinicalTrials.gov
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