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

NCT05232396 | Completed Phase 1 DMC

• 1 other identifier: HJG-KBJS6-WDJ-Ⅰb
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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 Rheumatoid Arthritis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Safety as measured by patients with adverse events

  The number of occurrences and incidence are calculated

  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

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

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

• Maximum observed plasma concentration (Cmax)

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

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

Secondary Outcomes (5)

• ACR20 ACR 50 ACR 70 response rate

  At the 4th and 8th week of medication

• Clinical Disease Activity Index (CDAI) response rate

  At the 4th and 8th week of medication

• HAQ- DI

  At the 4th and 8th week of medication

• FACIT-F

  At the 4th and 8th week of medication

• Analysis of immunogenicity

  From Day15-Day71 after administration

Study Arms (4)

IL-6R Monoclonal Antibody Injection 4mg/kg

EXPERIMENTAL

IL-6R Monoclonal Antibody Injection 4mg/kg, single dose usage

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

IL-6R Monoclonal Antibody Injection 6mg/kg

EXPERIMENTAL

IL-6R Monoclonal Antibody Injection 6mg/kg, single dose usage

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

IL-6R Monoclonal Antibody Injection 8mg/kg

EXPERIMENTAL

IL-6R Monoclonal Antibody Injection 8mg/kg, single dose usage

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

Tocilizumab Injection 8mg/kg

ACTIVE COMPARATOR

Tocilizumab Injection 8mg/kg，as active comparator, single dose usage.

Biological: Tocilizumab Injection 8mg/kg

Interventions

IL-6R Monoclonal Antibody Injection 4mg/kg BIOLOGICAL

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

IL-6R Monoclonal Antibody Injection 4mg/kg

IL-6R Monoclonal Antibody Injection 6mg/kg BIOLOGICAL

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

IL-6R Monoclonal Antibody Injection 6mg/kg

IL-6R Monoclonal Antibody Injection 8mg/kg BIOLOGICAL

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

IL-6R Monoclonal Antibody Injection 8mg/kg

Tocilizumab Injection 8mg/kg BIOLOGICAL

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

Tocilizumab Injection 8mg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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\];
• 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:

Sponsors & Collaborators

• Beijing VDJBio Co., LTD.: lead

Study Sites (5)

Affiliated Hospital of Hebei University

Baoding, China

Location

Peking University People's Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Pingxiang City People's Hospital

Pingxiang, China

Location

Peking University Shenzhen Hospital

Shenzhen, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zhanguo Li, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Yi Fang, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: February 9, 2022
• Study Start: March 2, 2021
• Primary Completion: October 27, 2021
• Study Completion: February 25, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)