Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
Taizhou Mabtech Pharmaceutical Co., Ltd, Taizhou, People's Republic of China.
Drug Des Devel Ther. 2024 Aug 29;18:3891-3901. doi: 10.2147/DDDT.S470619. eCollection 2024.
Secukinumab, a monoclonal antibody targeting interleukin (IL)-17A, is approved for the treatment of psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa. This study compared the pharmacokinetics (PK), safety, and immunogenicity of CMAB015, a candidate secukinumab biosimilar, with the reference product secukinumab (Cosentyx) in healthy Chinese male subjects.
This double-blind, parallel-group study randomized healthy Chinese male subjects (N=130) to receive either a single dose of 150 mg CMAB015 or secukinumab subcutaneously. Primary study endpoints were PK parameters such as the maximum concentration (C) and area under the curve from zero to infinity (AUC), while safety and immunogenicity were secondary endpoints.
The 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of C and AUC for CMAB015 to secukinumab were all within the bioequivalence limits (80.00-125.00%). Other PK parameters were comparable between the groups. The safety profile of CMAB015 was similar to that of secukinumab, with no serious adverse events related to treatment. The incidence of TEAEs was slightly higher in the CMAB015 group, but these events were mild to moderate in severity and did not lead to any withdrawals from the study. Immunogenicity analysis revealed low rates of anti-drug antibody (ADA) positivity, with similar rates between CMAB015 and secukinumab.
This study demonstrated equivalent PK, comparable safety, and immunogenicity of CMAB015 to secukinumab in healthy Chinese male subjects. These findings support further clinical evaluation of CMAB015 as a secukinumab biosimilar.
The trial was registered on Clinicaltrials.gov (Identifier No. NCT05734482) and Chinadrugtrials.org.cn (Identifier No. CTR20230105).
靶向白细胞介素（IL）-17A 的单克隆抗体司库奇尤单抗已获批准用于治疗银屑病、银屑病关节炎、强直性脊柱炎、非放射学中轴型脊柱关节炎、附着点炎相关关节炎和化脓性汗腺炎。本研究比较了健康中国男性受试者中候选司库奇尤单抗生物类似药 CMAB015 与参照产品司库奇尤单抗（Cosentyx）的药代动力学（PK）、安全性和免疫原性。
这项双盲、平行组研究将 130 名健康中国男性受试者随机分组，接受单次皮下注射 150mg CMAB015 或司库奇尤单抗。主要研究终点为 PK 参数，如最大浓度（C）和从 0 到无穷大的曲线下面积（AUC），安全性和免疫原性为次要终点。
CMAB015 与司库奇尤单抗的 C 和 AUC 的几何均数比值（GMR）的 90%置信区间（CI）均在生物等效性范围内（80.00-125.00%）。两组间其他 PK 参数相似。CMAB015 的安全性特征与司库奇尤单抗相似，无与治疗相关的严重不良事件。CMAB015 组的治疗相关不良事件（TEAE）发生率略高，但这些事件的严重程度为轻度至中度，且未导致任何受试者退出研究。免疫原性分析显示，抗药物抗体（ADA）阳性率较低，CMAB015 与司库奇尤单抗的阳性率相似。
本研究表明，CMAB015 在中国健康男性受试者中的 PK 等效，安全性和免疫原性与司库奇尤单抗相当。这些发现支持进一步评估 CMAB015 作为司库奇尤单抗生物类似药的临床研究。
该试验在 Clinicaltrials.gov（注册号：NCT05734482）和 Chinadrugtrials.org.cn（注册号：CTR20230105）上注册。
