This is a multicenter, randomized, double-blind, placebo and tocilizumab controlled phase II trial in RA patients to evaluate the initial efficacy, safety, pharmacokinetic, pharmacodynamic characteristics, and immunogenicity of VDJ001 in RA patients.

Start Date26 May 2022

Sponsor / Collaborator

Beijing Weidejie Biotechnology Co., Ltd.

CTR20220613 / CompletedPhase 2

VDJ001 治疗中重度活动性类风湿关节炎患者的随机、双盲、安慰剂及阳性药对照 II 期临床试验

[Translation] A randomized, double-blind, placebo- and active drug-controlled Phase II clinical trial of VDJ001 in patients with moderately to severely active rheumatoid arthritis

以阳性药托珠单抗和安慰剂为对照，评价重组人源化抗白介素-6 受体单克隆抗体注射液在中重度活动性类风湿关节炎（RA）患者中的初步疗效及剂量与疗效之间的关系。

[Translation]

To evaluate the preliminary efficacy of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection in patients with moderately to severely active rheumatoid arthritis (RA) and the relationship between dose and efficacy, using active drug tocilizumab and placebo as controls.

Start Date26 May 2022

Sponsor / Collaborator

Beijing Weidejie Biotechnology Co., Ltd.

CTR20220163 / RecruitingPhase 2

评价重组人源化抗白介素-6受体单克隆抗体注射液用于治疗特发性多中心型Castleman病（iMCD）患者中有效性和安全性的单臂、开放性、多中心IIa期临床研究

[Translation] A single-arm, open-label, multicenter phase IIa clinical study to evaluate the efficacy and safety of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection in the treatment of patients with idiopathic multicentric Castleman disease (iMCD)

主要目的：评估VDJ001在 iMCD患者中的安全性和耐受性，确定后续研究推荐剂量。次要目的：评估VDJ001在 iMCD患者中的初步疗效、免疫原性和 PK、 PD特征。

[Translation]

Primary purpose: Evaluate the safety and tolerability of VDJ001 in iMCD patients and determine the recommended dose for subsequent studies. Secondary purpose: Evaluate the preliminary efficacy, immunogenicity, and PK and PD characteristics of VDJ001 in iMCD patients.

Start Date18 Apr 2022

Sponsor / Collaborator

Beijing Weidejie Biotechnology Co., Ltd.

100 Clinical Results associated with VDJ-001

100 Translational Medicine associated with VDJ-001

100 Patents (Medical) associated with VDJ-001

Literatures (Medical) associated with VDJ-001

01 Jan 2024·Aging and disease

Responsiveness to Tocilizumab in Anti-Acetylcholine Receptor-Positive Generalized Myasthenia Gravis

Article

Author: Shi, Fu-Dong ; Zhang, Chao ; Zhang, Fenghe ; Jin, Zhao ; Shen, Yi ; Li, Huining ; Jia, Dongmei

Tocilizumab, a humanized IL-6R monoclonal antibody, has been used in autoimmune diseases closely related to humoral immunity. This report aims to evaluate the efficacy and safety in patients with anti-acetylcholine receptor-positive (AChR+) generalized myasthenia gravis (gMG). We performed a prospective, open-label, single-arm study in patients with gMG in a 48-week follow-up. All patients were AChR+ and were given tocilizumab by intravenous infusion at a dose of 8 mg/kg at intervals of 4 weeks. The primary endpoint was mean change from baseline in quantitative MG (QMG) score at week 12. The secondary endpoints were mean changes from baseline in MG activities of daily living (MG-ADL) score, AChR-ab titers, and the dosage of oral prednisone at week 12. At week 48, QMG, MG-ADL, and the use of prednisone were also evaluated. Fourteen gMG patients were enrolled and all of them completed the study. Tocilizumab treatment started 8 (4-192) months after the onset of gMG. During tocilizumab treatment, the QMG score was significantly decreased from 15.5 (interqualile range, 9-26) at baseline to 4 (0-9) at week 12 (p < 0.001). The change of ADL was decreased from 14.5(11-19) at baseline to 4 (0-19) at week 12 (p < 0.001) and the change of AChR-ab titers from 15 (7.5-19) at baseline to 6.8 (11.6-4.3) at week 12 (p < 0.001). The dosage of prednisone decreased from baseline 60 (20-65) mg/d to 30 (30-50) mg/d at week 12 (p < 0.001). By the end of the study, the QMG score was 2 (0-7) and MG-ADL score was 1.5 (0-6). 12 (85.7%) patients achieved minimal manifestations. 4 (28.6%) patients were able to discontinue prednisone. No patients experienced exacerbation at the end of the study. No serious adverse events were observed during follow-up. Tocilizumab treatment was associated with a good clinical response and safety over a 48-week observation period, as evidenced by significant improvements in QMG and MG-ADL.

01 Jan 2024·Neurology Neuroimmunology & Neuroinflammation

Long-term Effects of IL-6 Receptor Blockade Therapy on Regulatory Lymphocytes and Neutrophils in Neuromyelitis Optica Spectrum Disorder

Article

Author: Chihara, Norio ; Lin, Youwei ; Araki, Manabu ; Sato, Wakiro ; Miyamoto, Katsuichi ; Tachimori, Hisateru ; Matsuoka, Takako ; Okamoto, Tomoko ; Gold, Ralf ; Yamamura, Takashi ; Kimura, Atsuko ; Kusunoki, Susumu

BACKGROUND AND OBJECTIVESNeuromyelitis optica spectrum disorder (NMOSD) is a disabling autoimmune neurologic disease. Anti-IL-6 receptor (IL-6R) therapy prevents relapses in patients with anti-aquaporin 4 (AQP4)-IgG-positive NMOSD; however, it remains unclear how cellular immune components are altered by anti-IL-6R therapy. In this study, we examined the long-term effects of the anti-IL-6R monoclonal antibody tocilizumab (TCZ) on immune cell profiles in patients with NMOSD.METHODSMonthly IV injections of TCZ (8 mg/kg) were administered as an add-on therapy to 19 anti-AQP4-IgG-positive patients, who had been refractory to corticosteroids and immunosuppressive drugs. Peripheral blood was collected before infusion of TCZ for flow cytometry analysis of lymphocyte subsets. Seven patients provided whole blood samples for gene expression profiles.RESULTSPatients with NMOSD had reduced numbers of lymphocyte subsets with regulatory functions, including transitional B cells, CD56^high NK cells, and CD45RA^-FoxP3^high regulatory T cells. However, after initiating TCZ therapy, the numbers increased to normal levels within 1 year. Gene expression analysis revealed that neutrophil granule-related genes, predominated by those related to azurophil granules, were significantly upregulated in patients with NMOSD. Such alterations suggestive of accelerated myeloid turnover were not observed 1 year after TCZ therapy, and the effects of TCZ on some neutrophil genes were observed as early as 5 days after starting TCZ. In vitro analysis demonstrated that naïve T-cell division was impaired in the enrolled patients, which was fully recovered after 18 months of therapy.DISCUSSIONIn patients with active NMOSD not treated with molecular targeting drugs, we observed reduction or deficiency in lymphocytes with regulatory potentials and activation of neutrophils. However, introduction of anti-IL-6R therapy accompanied by tapering concomitant drugs corrected such abnormalities, which might contribute to persistent relapse prevention. The recovery in the naïve T-cell division after starting TCZ may underlie the relatively low risk of infection in patients under anti-IL-6R therapy.TRIAL REGISTRATION INFORMATIONUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000005889 (July 8, 2011) and UMIN000007866 (May 1, 2012) (umin.ac.jp/ctr/index.htm). The first participant was enrolled on November 2, 2011.

01 Jan 2023·Frontiers in pharmacology

LZM008, a proposed tocilizumab biosimilar: pharmacokinetics, safety, and immunogenicity profiles compared with ACTEMRA in Chinese healthy male subjects

Article

Author: Gu, Xianghong ; Wang, Jingjing ; He, Jinjie ; Zhang, Jing ; Wu, Xiaojie ; Hu, Yingying ; Yang, Haijing ; Fang, Wei ; Wu, Jufang ; Yu, Jicheng ; Cao, Guoying ; Que, Linling ; He, Qing

Background: This study aimed to investigate the pharmacokinetics, safety, and immunogenicity of recombinant humanized anti-human IL-6R monoclonal antibody injection, LZM008, and evaluate the pharmacokinetic similarity between LZM008 and tocilizumab (ACTEMRA^®) in Chinese healthy male subjects. Research design and methods: In this randomized, double-blinded, paralleled, two-center Phase I clinical trial, 96 subjects were randomized with a 1:1 ratio to receive 4 mg/kg intravenous dose of LZM008 or ACTEMRA^® and evaluated for 28 days. The pharmacokinetic bioequivalence was assessed by the maximum serum concentration (C_max), the area under the serum concentration-time curve (AUC) from time 0 to the last detectable drug concentration (AUC_0-t), and AUC_0-∞. The statistical analysis was conducted using SAS Enterprise Guide statistical software. Safety was assessed by physical examinations, vital signs, laboratory tests, and electrocardiograms. Anti-drug antibodies (ADAs) were measured by a bridged electrochemiluminescence immunoassay. Results: LZM008 (N = 49) and ACTEMRA^® (N = 47) groups showed similar pharmacokinetic properties. After a single intravenous infusion of 4 mg/kg LZM008, the C_max and AUC_0-∞ values of LZM008 reached 87.99 μg/mL and 11,526.70 h*μg/mL, respectively, with T_max 1.98 h, and the half-life (t_1/2) was 83.45 h. The 90% confidence intervals of ratios for C_max, AUC_0-t, and AUC_0-∞ were within the range of 80.00%-125.00%. After infusion, one (2.0%) subject in the LZM008 group and three (6.4%) subjects in the ACTEMRA^® group showed positive ADA test results. The incidence of treatment emergent adverse events (TEAEs) was comparable in LZM008 and ACTEMRA^® groups (98.0% versus 100%), with the decrease in blood fibrinogen and neutrophil counts being the most common TEAEs. Conclusion: The pharmacokinetic characteristics and immunogenicity exhibited by LZM008 were similar to those of the reference product, ACTEMRA^®. The safety profiles of LZM008 were similar in the two groups with mild-moderate adverse effects. Trial Registration: The trial is registered at www.chinadrugtrials.org.cn (CTR20190889).

100 Deals associated with VDJ-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	CN	Beijing Weidejie Biotechnology Co., Ltd.	26 May 2022
Multi-Centric Castleman's Disease	Phase 2	CN	Beijing Weidejie Biotechnology Co., Ltd.	18 Apr 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05957107 \| CTR20220613 (EULAR2024) Manual	Phase 2	Rheumatoid Arthritis	180	VDJ-001 4mg/kg	(bunkjvskxz) = gdalqquhcg hyeppfsysf (lfyyfyapqp ) View more	Positive	05 Jun 2024
				VDJ-001 6mg/kg	(bunkjvskxz) = ckxusyjdkm hyeppfsysf (lfyyfyapqp ) View more
NCT05957107 \| CTR20220613 (NEWS) Manual	Phase 2	Rheumatoid Arthritis	181	VDJ-001 4mg/kg	(dvvekfesnb) = 此研究已达到主要终点 adyejhvxtg (eawpzaynch ) Met	Positive	07 Aug 2023
				VDJ-001 6mg/kg
EHA2023	Not Applicable	Multi-Centric Castleman's Disease	9	VDJ001 infusion 4mg/kg	cukdqcbprt(utefnjdnjv) = significant improvements afmiydnfuf (imioxkkrfc ) View more	-	08 Jun 2023
				VDJ001 infusion 6mg/kg

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