Clinical Study of a IL-6R Injection in Patients With RA

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT05232396
• Date of registration: 25/11/2021
• Prospective Registration: No
• Primary sponsor: Beijing VDJBio Co., LTD.
• Public title: Clinical Study of a IL-6R Injection in Patients With RA
• Scientific title: Phase Ib Clinical Study of Safety and Tolerability , PK/PD Parameters and Preliminary Efficiency of a IL-6R Injection Monoclonal Antibody Injection in Patients With Moderate to Severe Active Rheumatoid Arthritis
• Date of first enrolment: March 2, 2021
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05232396
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Zhanguo Li, M.D.
• Affiliation: Peking University People's Hospital

• Name: Yi Fang, PhD
• Affiliation: Peking University People's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age at the time of screening is 18~70 years old (including boundary value), gender is
not limited;

2. According to the standards revised by the American College of Rheumatology (ACR) in
1987, or the American College of Rheumatology/Europe Anti-Rheumatism Alliance
(ACR/EULAR) 2010 classification criteria, patients diagnosed with adult RA and The
history of RA is at least 6 months;

3. Patients with moderate to severe active RA at screening and baseline visit, defined as
having at least 6/68 joints Tenderness or pain and swelling of at least 6/66 joints
during exercise After major surgical treatment, for the screening of this study, joint
tenderness count (TJC) and closed The joint swelling count (SJC) evaluation, this
joint cannot be counted);

4. Erythrocyte sedimentation rate (ESR) =28mm/hour, or C-reactive protein = 10mg/L;

5. Before screening, due to lack of efficacy or intolerance, poor response to MTX
treatment;

6. Have received and tolerated at least 7.5mg/week MTX treatment for at least 12 weeks
before screening, and within 4 weeks before screening The dose of MTX is stable within
the range of =7.5mg/week and =20mg/week. This MTX dose is expected to remain stable
during the study period It will only be adjusted for safety reasons;

7. If subjects are using non-steroidal anti-inflammatory drugs (NSAIDs) or other
analgesics to treat RA, they must be stable before enrollment.

Fixed-dose treatment for at least 2 weeks;

8. If the subject takes glucocorticoids orally, the dose must be stabilized at least 4
weeks before enrollment to be equivalent to =10mg Prednisone/day dose;

9. Subjects who receive non-disabled concomitant drug treatment for any reason must
always be on a stable treatment plan, definition It is that no new drug has been taken
or the dosage has been changed within 7 days or 5 half-lives (whichever is longer)
before screening;

10. Sign the informed consent form voluntarily.

Exclusion Criteria:

1. Have used DMARDs other than MTX (including sulfasalazine, antimalarial drugs,
penicillamine, Azathioprine, cyclosporine A, cyclophosphamide, etc.), botanical drugs
(including tripterygium wilfordii, total glucosides of paeony, sinomenine, etc.), and
Those who have received any viral vaccine (such as influenza vaccine) immunotherapy;

2. Those who have had major trauma or undergone major surgery within 4 weeks before
screening, or plan to receive medical treatment within 2 months after randomization.

Those who have undergone major surgery;

3. Those who have used intra-articular, intramuscular or intravenous corticosteroids
within 6 weeks before screening;

4. Anuranofin, gold glucosinolate (gold for injection), gold thiomalate (gold for
injection) have been used within 8 weeks before screening Or those immunized with oral
polio vaccine;

5. Those who received flunomide treatment within 12 weeks before screening (if receiving
standard cholestyramine elution treatment 4 weeks before screening) (Cholestyramine 8g
orally, 3 times a day for 11 consecutive days), then the subject can be included];

6. Those who have intravenous injection of gamma globulin, plasma exchange or use
prosorba column within 24 weeks before screening;

7. Anakinra and Etanercept were used within 4 weeks before screening; Adalimumab and
Etanercept were used within 8 weeks before screening Fliximab; Golimumab and
Certuzumab used within 10 weeks before screening; Abba within 12 weeks before
screening Cipro; used denosumab within 21 weeks before screening; used rituximab
within 26 weeks before screening;

8. Those who have used tocilizumab in the past;

9. Uncontrolled cardiovascular system, respiratory system, digestive system, endocrine
system, blood as judged by the investigator System, nervous system or psychiatric
disorder or any other serious and/or unstable disease or medical history, and the
investigator agrees For these diseases or medical history, taking study drugs may
bring risks or interfere with the interpretation of data;

10. People with autoimmune diseases other than RA, including but not limited to psoriatic
arthritis (PsA), ankylosing spine Inflammation (AS), systemic lupus erythematosus
(SLE) or Lyme disease;

11. New York Heart Association functional class IV;

12. Non-metastatic basal cell carcinoma that has been adequately treated or resected in
patients with malignant tumors or a history of malignant tumors Or squamous cell
carcinoma or cervical cancer in situ;

13. The 12-lead electrocardiogram (ECG) is abnormal at the time of screening, and the
investigator or sponsor believes that the abnormality has clinical significance And it
may bring unacceptable risks to patients participating in this study (for example,
Fridericia corrected QT interval>500 msec);

14. Laboratory screening test values have any of the following specific abnormalities:

AST or ALT>2 times ULN; Total bilirubin >=1.5 times ULN; Hemoglobin <80.0g/L; Total
white blood cell count<3.5×109/L; Neutropenia (absolute neutrophil count <1.5×109/L);
Lymphopenia (lymphocyte count<0.75×109/L); Thrombocytopenia (platelet count<80×109/L);
Creatinine> upper limit of normal; Triglycerides>10mmol/L;

15. Those with a history of infection of the prosthesis and the prosthesis is still in
place;

16. There is evidence of active tuberculosis (TB), or there has been evidence of active TB
before and has not received appropriate documented treatment; those with hidden
tuberculosis infection are defined as tuberculin skin test (PPD) induration greater
than 5mm Or those who have a positive interferon-gamma release test (such as TSPOT)
and have not been treated for preventive tuberculosis for 4 weeks;

17. Patients with clinically significant infections within 6 months before screening (for
example, those who need hospitalization or parenteral antibacterial treatment or
opportunistic infections) Person), or have more than 1 oral or genital herpes, or
history of herpes zoster, history of disseminated herpes, researchers Any history of
infection that is judged to be likely to worsen due to participation in the study by
other means, or need antibacterial within 2 weeks after screening Any person with a
history of infections treated;

18. Those who plan to vaccinate or take oral vaccines during the study treatment period or
within 8 weeks after study completion/early withdrawal;

19. Those with a history of any lymphoproliferative dis


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: IL-6R Monoclonal Antibody Injection 4mg/kg

Biological: Tocilizumab Injection 8mg/kg

Biological: IL-6R Monoclonal Antibody Injection 6mg/kg

Biological: IL-6R Monoclonal Antibody Injection 8mg/kg

Primary Outcome(s)

Maximum observed plasma concentration (Cmax) [Time Frame: First dose up to last follow-up visit(Day1-Day57)]

AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of IL-6R [Time Frame: First dose up to last follow-up visit(Day1-Day57)]

Number of subject with adverse events(AEs) [Time Frame: First dose up to last follow-up visit(Day1-Day57)]

Secondary Outcome(s)

Analysis of immunogenicity [Time Frame: From Day15-Day71 after administration]

FACIT-F [Time Frame: At the 4th and 8th week of medication]

Clinical Disease Activity Index (CDAI) good response rate [Time Frame: At the 4th and 8th week of medication]

HAQ- DI [Time Frame: At the 4th and 8th week of medication]

ACR20 ACR 50 ACR 70 responder rates [Time Frame: At the 4th and 8th week of medication]

Secondary ID(s)

HJG-KBJS6-WDJ-?b

Source(s) of Monetary Support

Please refer to primary and secondary sponsors