Rheumatoid ArthritisPhase 1NCT04179513
A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients
A Phase 1 study testing GB224 10mg and GB224 20mg in people with Rheumatoid Arthritis, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups; the secondary objectives… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GB224 10mg and GB224 20mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Understand the study procedures and contents, voluntarily participate in the clinical trial and sign the informed consent form;
- Aged 18 to 75 years, males or females;
- Subjects who have confirmed rheumatoid arthritis for at least 3 months according to 2010 American College of Rheumatology Classification Criteria (amendment);
- The active stage is met at screening: the following 3 items should be met (based on 28 joints): swelling of 4 or more joints; tenderness of 6 or more joints; at least one of the following criteria is met: erythrocyte sedimentation rate >28mm/h or C-reactive protein >10mg/L (1.0mg/dL);
- Subjects who have been treated with MTX treatment for at least 12 weeks before the before the use of investigational products and the dose remains stable (10~15mg/week) for at least 4 weeks;
- The following DMARDs except MTX (including but not limited to chloroquine, hydroxychloroquine, gold preparation, penicillamine, sulfasalazine, azathioprine, cyclophosphamide, cyclosporin A, glucosinolate, auranofin etc.) are discontinued at least 4 weeks before the use of investigational products. Should any leflunomide is previously used, the subjects can be enrolled after washout with cholestyramine (8g, three times per day) for 11 days. If leflunomide is discontinued 12 weeks ago, the patients can be enrolled without washout with cholestyramine.
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- Use of TNF-α antagonists (approved orexploratory new agents) is allowed before the use of investigational products, however, it should be discontinued at least 4 weeks before administration of investigational products due to inadequate response, intolerability or economic reasons. If similar biological preparations (IL-6/IL-6R antagonists) were given before the use of investigational products, inadequate response and intolerability should be not observed and the drug should be discontinued at least 3 months ago.
- If glucocorticoids are being administered before the use of investigational products, the dose must be stable and remains ≤10mg/d (equivalent to the dose of prednisone) for at least 4 weeks; if no glucocorticoids are used, no oral administration is given at least 4 weeks ago.
- If the non-steroidal anti-inflammatory drugs (NSAIDs) are being administered before the use of investigational products, the dose should be stable for at least 2 weeks.
- Female subjects of child-bearing potential have negative pregnancy test at screening; both males and females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
- Be able to understand and complete assessment forms;
- Subjects can well communicate with the investigators and complete the study as required by the study.
Who cannot join
- Be allergic to any exicipent of the investigational products or any other animal-derived protein, or hypersensitivity to immunoglobulin products; Subjects who are known to have medical history of allergic diseases or allergic constitution;
- Subjects with rheumatoid arthritis with joint function classification of grade IV or subjects who combined to chair or bed;
- Use of intramuscular injection, intravenous injection or intra-articular injection of glucocorticoids (including intramuscular injection of ACTH) within 4 weeks before the use of investigational products.
- Inoculation with live (attenuated) vaccine within 4 weeks before the use of investigational products;
- Treatment with interferon within 4 weeks before the use of investigational products;
- Participation in clinical trials of other drugs within 3 months before the use of investigational products;
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- Any of the following is positive at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
- Patients with known tuberculosis infection and patients with high risks for tuberculosis infection should be excluded. If patients with obsolete tuberculosis and latent tuberculosis infection (LTBI) agree to receive preventive anti-tuberculosis therapies (appendix 5) during the study period, they can be enrolled. Or, they will be excluded. (1) Known tuberculosis infection (any of the following criteria is met): active tuberculosis infection or presence of clinical signs and symptoms of suspected tuberculosis (pulmonary or extrapulmonary), presence of active tuberculosis infection involved any organ system, or symptoms of other organ systems corresponding to tuberculosis infection; (2) High risks for tuberculosis infection (any of the following criteria is met): known to be in close contact with active tuberculosis patients within 3 months before screening; subjects with low immunoligic function and with evidence showing any latent tuberculosis infection (LTBI); long stay with individuals infected with tuberculosis or long stay in medical service environment or institutions with high risks for tuberculosis transmission and infection; If patients with obsolete tuberculosis and latent tuberculosis infection (LTBI) agree to receive preventive anti-tuberculosis therapies (refer to appendix 5) during the study period and have received anti-tuberculosis monotherapy for at least 4 weeks, they can be enrolled. Or, they will be excluded. Obsolete tuberculosis: the radiology test or other imaging tests showing evidence of previous infection at screening or within the previous 3 months (obsolete tuberculosis evidence: scars of lung and/or pleural fiber; calcification of apex of lung or other sites; pulmonary hilus and /or mediastinal lymph node lesions; decreased volume of upper lobe of lung; pulmonary cavity). LTBI is defined as no evidence showing signs or symptoms of tuberculosis infection or abnormal physical examination, and chest X-ray test (other imaging tests) results showing no evidence of current tuberculosis infection, however, interferon gamma release assay (IGRA) is positive or the results of two IGRA tests are not clear.
- Previous opportunistic infection (herpes zoster, cytomegalovirus, mycoplasma, pneumocystis carinii, histoplasma capsulatum, candida, aspergillus, mycobacterium other than mycobacterium tuberculosis etc.) within 6 months before screening;
- Medical history of chronic infection (e.g., chronic hepatitis, chronic renal infection etc.), serious or life-threatening infection (e.g., hepatitis, pneumonitis and pyelonephritis etc.) or any current symptoms or signs indicating possible presence of infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
- Subjects who are in high risk for infection (e.g., leg ulcer, retention catheterization, persistent or recurrent chest infection and bedridden or wheelchair-bound for a long term)
- Medical history of lymphoproliferative disorder (including lymphoma, or signs or symptoms reflecting lymphoproliferative disorders at any time); or splenomegaly
- Patients who previously or currently have malignant tumors within 5 years before screening (excluding adequately treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical in situ carcinoma);
- Current or previous presence of congestive heart failure or medical history of congestive heart failure;
- Current presence of interstitial lung disease or medical history of previous interstitial lung disease;
- Current or previous presence of multiple sclerosis or other demyelinating diseases of the central nervous system or corresponding medical history of these diseases;
- There is evidence showing that the subjects have serious, progressive and uncontrolled cardiovascular, renal, hepatic, hemopoietic, gastrointestinal, endocrine, pulmonary, nervous system disorders; and other conditions who are considered unsuitable for participating in this study at the discretion of the investigator;
- The following abnormal laboratory variables should be excluded: white blood cells (WBC) <3.5×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT) <100×109/L, hemoglobin (HGB) <85g/L, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alkaline phosphatase (ALP)> 2 times the upper limit of normal (ULN), serum creatinine (Cr) > 1.5 times ULN, triglycerides (TG)> 2 times ULN;
- Subjects who currently or previously have other immune diseases (e.g., systemic lupus erythematosus, psoriasis or ankylosing spondylitis) which are considered unsuitable for participating in this study at the discretion of the investigator or subjects who have symptoms and signs of other diseases which are expected to affect the evaluation of investigational product;
- Subjects with medical history of prosthetic joint infection and the artificial joints are still in the body;
- Subjects who received arthroplasty for more than 3 times;
- Subjects who received organ transplantation within 6 months before screening;
- Lactating women;
- Subjects who have medical history of long-term alcohol abuse or drug abuse;
- Subjects who have insufficient communication, understanding and cooperation, or subjects who have low education level, cannot understand and correctly complete corresponding forms, subjects who have history of noncompliance with doctor's instructions to receive administration, or subjects who have other conditions which may interfere with protocol compliance of subjects (e.g., subjects who have psychiatric disorders or usually travel, and lack of motivation to participate in the study);
- Subjects who have other diseases (e.g., clinically significant symptoms or abnormal laboratory variables) which are considered unsuitable for participating in this clinical study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100191
Zhaoguo Li, Ph.D, 010-88326666
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups; the secondary objectives are to preliminarily evaluate the clinical efficacy such as ACR20 at week 32, ACR20, ACR50 and ACR70 at weeks 12 and 24, ACR50 and ACR70 at week 32, and DAS28 at weeks 12, 24 and 32 of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups as well as to preliminarily understand the immunogenicity and changes in pharmacodynamic variable (IL-6) of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GB224 10mg, GB224 20mg
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB224 10mgBiological
Also called Methotrexate (MTX)
10 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given.
Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses.
GB224 20mgBiological
Also called Methotrexate (MTX)
20 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given.
Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses.
| Study group | Role | What they receive |
|---|---|---|
| GB224 10mg | Experimental | GB224 10mg Receives: Biological: GB224 10mg |
| GB224 20mg | Experimental | GB224 20mg Receives: Biological: GB224 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Effect, AE
Adverse Effect, AE
Measured: Up to 224 days.
Serious Adverse Effect, SAE
Serious Adverse Effect, SAE
Measured: Up to 224 days.
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Measured: Up to 224 days.
Dose Limited Toxicity, DLT
Dose Limited Toxicity, DLT
Measured: Up to 224 days.
Cmax
Cmax
Measured: Up to 224 days.
AUC 0-∞
AUC0-∞
Measured: Up to 224 days.
Accumulation Factor
Accumulation Factor
Measured: Up to 224 days.
CL/Fsc
CL/Fsc
Measured: Up to 224 days.
Vd/Fsc
Vd/Fsc
Measured: Up to 224 days.
Tmax
Cmax, AUC0-∞, AR, CL/Fsc, Vd/Fsc, Tmax
Measured: Up to 224 days.
Secondary outcomes (6)
Number of patients with ACR20
Number of patients with ACR20
Measured: Up to 224 days.
Number of patients with ACR50
Number of patients with ACR50
Measured: Up to 224 days.
Number of patients with ACR70
ACR70
Measured: Up to 224 days.
Number of patients with DAS28
Number of patients with DAS28
Measured: Up to 224 days.
Anti-Drug Antibody, ADA
Anti-Drug Antibody, ADA
Measured: Up to 224 days.
Concentration of Serum IL-6
Concentration of Serum IL-6
Measured: Up to 224 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start15 Aug 2019
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoguo Li, Ph.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179513
- Sponsor's protocol ID
- GENOR GB224-002; V2.1
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups
- ClinicalTrials.gov ID
- NCT04179513
- Acronym / sponsor ID
- GENOR GB224-002; V2.1
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 27 Nov 2019 (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.
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups; the secondary objectives are to preliminarily evaluate the clinical efficacy such as ACR20 at week 32, ACR20, ACR50 and ACR70 at weeks 12 and 24, ACR50 and ACR70 at week 32, and DAS28 at weeks 12, 24 and 32 of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups as well as to preliminarily understand the immunogenicity and changes in pharmacodynamic variable (IL-6) of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB224 10mg | Experimental | Biological: GB224 10mgGB224 10mg |
| GB224 20mg | Experimental | Biological: GB224 20mgGB224 20mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Understand the study procedures and contents, voluntarily participate in the clinical trial and sign the informed consent form;
- Aged 18 to 75 years, males or females;
- Subjects who have confirmed rheumatoid arthritis for at least 3 months according to 2010 American College of Rheumatology Classification Criteria (amendment);
- The active stage is met at screening: the following 3 items should be met (based on 28 joints): swelling of 4 or more joints; tenderness of 6 or more joints; at least one of the following criteria is met: erythrocyte sedimentation rate >28mm/h or C-reactive protein >10mg/L (1.0mg/dL);
- Subjects who have been treated with MTX treatment for at least 12 weeks before the before the use of investigational products and the dose remains stable (10~15mg/week) for at least 4 weeks;
Key exclusion criteria (26 listed)
- Be allergic to any exicipent of the investigational products or any other animal-derived protein, or hypersensitivity to immunoglobulin products; Subjects who are known to have medical history of allergic diseases or allergic constitution;
- Subjects with rheumatoid arthritis with joint function classification of grade IV or subjects who combined to chair or bed;
- Use of intramuscular injection, intravenous injection or intra-articular injection of glucocorticoids (including intramuscular injection of ACTH) within 4 weeks before the use of investigational products.
- Inoculation with live (attenuated) vaccine within 4 weeks before the use of investigational products;
- Treatment with interferon within 4 weeks before the use of investigational products;
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 |
|---|---|---|
| GB224 10mgAlso: Methotrexate (MTX)10 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given. Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses. | Biological | GB224 10mg |
| GB224 20mgAlso: Methotrexate (MTX)20 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given. Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses. | Biological | GB224 20mg |
Primary outcome
Adverse Effect, AE
Time frame: Up to 224 days.
Adverse Effect, AE
Serious Adverse Effect, SAE
Time frame: Up to 224 days.
Serious Adverse Effect, SAE
Maximum Tolerated Dose, MTD
Time frame: Up to 224 days.
Maximum Tolerated Dose, MTD
Dose Limited Toxicity, DLT
Time frame: Up to 224 days.
Dose Limited Toxicity, DLT
Cmax
Time frame: Up to 224 days.
Cmax
AUC 0-∞
Time frame: Up to 224 days.
AUC0-∞
Accumulation Factor
Time frame: Up to 224 days.
Accumulation Factor
CL/Fsc
Time frame: Up to 224 days.
CL/Fsc
Vd/Fsc
Time frame: Up to 224 days.
Vd/Fsc
Tmax
Time frame: Up to 224 days.
Cmax, AUC0-∞, AR, CL/Fsc, Vd/Fsc, Tmax
6 secondary outcomes
Number of patients with ACR20
Time frame: Up to 224 days.
Number of patients with ACR50
Time frame: Up to 224 days.
Number of patients with ACR70
Time frame: Up to 224 days.
Number of patients with DAS28
Time frame: Up to 224 days.
Anti-Drug Antibody, ADA
Time frame: Up to 224 days.
Concentration of Serum IL-6
Time frame: Up to 224 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhaoguo Li, Ph.D principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB224 10mg and GB224 20mg in people with Rheumatoid Arthritis, run by Genor Biopharma Co., Ltd. at 1 site 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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Yu, Master (010-65260820, Shawn.Yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Effect, AE (time frame: Up to 224 days.). The study lists 10 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 27 Nov 2019.