Systemic Sclerosis Associated Interstitial Lung DiseasePhase 2NCT06189495
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
A Phase 2 study testing GenSci048 in people with Systemic Sclerosis Associated Interstitial Lung Disease and Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
- What is being tested?
- GenSci048
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 30 Dec 2023to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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;
- Subjects 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.
Who cannot join
- 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; Tofaciib, tacrolimus, cyclosporin A, and potassium para-aminobenzoate were used 30 days or 5 half-lives prior to screening, whichever was older.
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610047
qibing xie, Doctor of Medicine(M.D.), 13808175616, xieqibing1971@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
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)
- Conditions
- Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
- Being tested
- GenSci048, GenSci048 placebo
- Keywords
- connective tissue disease-associated interstitial lung disease, Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci048Drug
- 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 placeboDrug
- 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).
- Administration method: subcutaneous injection; The injection site is the abdomen (3 cm away from the navel)
| Study group | Role | What they receive |
|---|---|---|
| GenSci048 | Experimental | 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 Receives: Drug: GenSci048 |
| GenSci048 placebo | Placebo comparator | .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) Receives: Drug: GenSci048 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function assessment:Subjects' lung function was assessed by FVC .
Measured: 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
Lung function assessment:Subjects' lung function was assessed by DLCO.
Measured: 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
tLung function assessment:Visual simulation score was used to evaluate Physician's Global Asseessment（PGA）
Measured: "Lung function assessment:The PGA is evaluated during the screening period and once every 12 weeks .From baseline up to 2 years.
Safety evaluation indicator：Adverse Events
Measured: From baseline up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 Dec 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis Associated Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- qibing xie, Doctor of Medicine(M.D.), Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189495
- Sponsor's protocol ID
- GenSci048-204
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- GenSci048-204
- Conditions
- Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
- Keywords
- connective tissue disease-associated interstitial lung disease, Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci048 | Experimental | Drug: GenSci0481. 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 | Placebo comparator | Drug: GenSci048 placebo.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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- FVC≥ 40% of the expected value during the screening period;
Key exclusion criteria (36 listed)
- 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 :
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci0481. 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 | Drug | GenSci048 |
| GenSci048 placebo1. 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) | Drug | GenSci048 placebo |
Primary outcome
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
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
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.
Safety evaluation indicator：Adverse Events
Time frame: From baseline up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
qibing xie, Doctor of Medicine(M.D.) study chair
West China Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GenSci048 in people with Systemic Sclerosis Associated Interstitial Lung Disease and Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shengnan wen (15130499319, wenshengnan@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.