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Rheumatoid ArthritisPhase 1NCT05232396

Clinical Study of Single Dose IL-6R mAb Injection in RA Patients

A Phase 1 study testing IL-6R Monoclonal Antibody Injection 4mg/kg, IL-6R Monoclonal Antibody Injection 6mg/kg and IL-6R Monoclonal Antibody Injection 8mg/kg in people with Rheumatoid Arthritis, run by Beijing VDJBio Co., LTD. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-dose,multi-center, randomized, double-blind, positive-controlled and parallel group clinical study that aims to evaluate the safety,tolerability,PK/PD characteristics and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody Injection in Patients With Active Moderate-to-Severe… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
IL-6R Monoclonal Antibody Injection 4mg/kg, IL-6R Monoclonal Antibody Injection 6mg/kg and IL-6R Monoclonal Antibody Injection 8mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesChina
Study dates
2 Mar 2021to 25 Feb 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at the time of screening is 18~70 years old (including boundary value), gender is not limited;
  • 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;
  • 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);
  • Erythrocyte sedimentation rate (ESR) ≥28mm/hour, or C-reactive protein ≥ 10mg/L;
  • Before screening, due to lack of efficacy or intolerance, poor response to MTX treatment;
  • 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;
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  • 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;
  • 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;
  • 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;
  • Sign the informed consent form voluntarily.

Who cannot join

  • 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;
  • 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;
  • Those who have used intra-articular, intramuscular or intravenous corticosteroids within 6 weeks before screening;
  • 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;
  • 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];
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  • Those who have intravenous injection of gamma globulin, plasma exchange or use prosorba column within 24 weeks before screening;
  • 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;
  • Those who have used tocilizumab in the past;
  • 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;
  • 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;
  • New York Heart Association functional class IV;
  • 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;
  • 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);
  • 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;
  • Those with a history of infection of the prosthesis and the prosthesis is still in place;
  • 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;
  • 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;
  • Those who plan to vaccinate or take oral vaccines during the study treatment period or within 8 weeks after study completion/early withdrawal;
  • Those with a history of any lymphoproliferative disease, such as EBV-related lymphoproliferative disease, lymphoma, leukemia, History of myeloproliferative disease, multiple myeloma, or current signs and symptoms of lymphatic disease;
  • People with uncontrolled asthma, psoriasis or inflammatory bowel disease who need oral corticosteroids for treatment;
  • Used before screening or planned to use lymphocyte depleting agents/therapies, alkylating agents, total lymphatic irradiation during the study period Other treatment methods;
  • Immediate family members or those who have hereditary immunodeficiency diseases;
  • Those who have been allergic to human or murine monoclonal antibodies in the past;
  • Those who suffer from active fibromyalgia and will make it difficult for researchers to accurately evaluate the RA activity in this study;
  • Serum virology examination: hepatitis B virus surface antigen, hepatitis C virus antibody, syphilis specific antibody, human Immunodeficiency virus-like virus antibody test, any one of which is positive;
  • With a history of alcohol or drug abuse, except for those who have been completely abstinent for more than 6 months before enrollment;
  • Those who have participated in any other clinical trials within 3 months before screening (only participated in the screening of clinical trials without using Except for subjects of test drugs);
  • Pregnant women, lactating women, or women of childbearing age who have a positive pregnancy test result during screening; or Those who have a childbirth plan during the trial period and within 3 months after the end of the study are unwilling to take it during the trial period and within 3 months after the end of the study One or more physical contraceptive measures;
  • The investigator believes that it is not suitable to participate in this clinical trial.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Peking University People's Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Pingxiang City People's Hospital

    Pingxiang

  • Peking University Shenzhen Hospital

    Shenzhen

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind Phase Ib Clinical Study to Evaluate the Safety, Tolerability, PK/PD Characteristics and Preliminary Efficacy of IL-6R mAb Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis.

This is a single-dose,multi-center, randomized, double-blind, positive-controlled and parallel group clinical study that aims to evaluate the safety,tolerability,PK/PD characteristics and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis.

Read the detailed description

This study is aim to evaluate the safety, tolerability, PK/PD characteristics, immunogenicity parameters and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis. There are 4 dose groups and each group enrolls 10 patients: 4mg/kg(IL-6R mAb); 6mg/kg(IL-6R mAb); 8mg/kg(IL-6R mAb) and 8mg/kg(tocilizumab ).each patient receives a single intravenous(i.v.) dose. The infusion time is from 60 to 90 minutes (the speed can be adjusted appropriately if there are injection reactions).

Being tested
IL-6R Monoclonal Antibody Injection 4mg/kg, IL-6R Monoclonal Antibody Injection 6mg/kg, IL-6R Monoclonal Antibody Injection 8mg/kg, Tocilizumab Injection 8mg/kg
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-6R Monoclonal Antibody Injection 4mg/kgBiological

    IL-6R Monoclonal Antibody Injection 4mg/kg i.v.,single use

  • IL-6R Monoclonal Antibody Injection 6mg/kgBiological

    IL-6R Monoclonal Antibody Injection 6mg/kg i.v. , single use

  • IL-6R Monoclonal Antibody Injection 8mg/kgBiological

    IL-6R Monoclonal Antibody Injection 8mg/kg i.v. , single use

  • Tocilizumab Injection 8mg/kgBiological

    Tocilizumab Injection 8mg/kg i.v., single use

Study groups in NCT05232396
Study groupRoleWhat they receive
IL-6R Monoclonal Antibody Injection 4mg/kgExperimentalIL-6R Monoclonal Antibody Injection 4mg/kg, single dose usage
Receives: Biological: IL-6R Monoclonal Antibody Injection 4mg/kg
IL-6R Monoclonal Antibody Injection 6mg/kgExperimentalIL-6R Monoclonal Antibody Injection 6mg/kg, single dose usage
Receives: Biological: IL-6R Monoclonal Antibody Injection 6mg/kg
IL-6R Monoclonal Antibody Injection 8mg/kgExperimentalIL-6R Monoclonal Antibody Injection 8mg/kg, single dose usage
Receives: Biological: IL-6R Monoclonal Antibody Injection 8mg/kg
Tocilizumab Injection 8mg/kgActive comparatorTocilizumab Injection 8mg/kg，as active comparator, single dose usage.
Receives: Biological: Tocilizumab Injection 8mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as measured by patients with adverse events

    The number of occurrences and incidence are calculated

    Measured: First dose up to last follow-up visit(Day1-Day57)

  2. AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of IL-6R

    AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of IL-6R

    Measured: First dose up to last follow-up visit（Day1-Day57）

  3. Maximum observed plasma concentration (Cmax)

    Maximum observed plasma concentration (Cmax) of IL-6R

    Measured: First dose up to last follow-up visit（Day1-Day57）

Secondary outcomes (5)

  1. ACR20 ACR 50 ACR 70 response rate

    The ACR20, ACR50 or ACR70 was achieved if there was at least a 20%, 50% or 70% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP

    Measured: At the 4th and 8th week of medication

  2. Clinical Disease Activity Index (CDAI) response rate

    CDAI improvement ≥50% or CDAI≤2.8

    Measured: At the 4th and 8th week of medication

  3. HAQ- DI

    Changes in health Assessment Questionnaire disability Index (HAQ-DI) from baseline

    Measured: At the 4th and 8th week of medication

  4. FACIT-F

    Chronic Disease Functional Assessment - Fatigue Scale (FACIT-F) score was relatively basic Line changes

    Measured: At the 4th and 8th week of medication

  5. Analysis of immunogenicity

    The concentrations of anti-drug antibody (ADA) and neutralizing antibody (NAb) in serum were detected

    Measured: From Day15-Day71 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start2 Mar 2021
  3. Primary completion27 Oct 2021
  4. Study completion25 Feb 2022

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05232396
Sponsor's protocol ID
HJG-KBJS6-WDJ-Ⅰb
Status last verified
Feb 2022
First submitted
25 Nov 2021
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IL-6R Monoclonal Antibody Injection 4mg/kg, IL-6R Monoclonal Antibody Injection 6mg/kg and IL-6R Monoclonal Antibody Injection 8mg/kg in people with Rheumatoid Arthritis, run by Beijing VDJBio Co., LTD. at 5 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 11 inclusion and 31 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: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as measured by patients with adverse events (time frame: First dose up to last follow-up visit(Day1-Day57)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05232396.

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 11 Mar 2022.

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