Research advances in targeting OX40/OX40L monoclonal antibodies for the treatment of atopic dermatitis

doi:10.12092/j.issn.1009-2501.2026.05.009

Abstract

Abstract:

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a T helper cells (th) 2-dominant immune response coupled with multifactorial immune dysregulation involving Th1, Th17, and Th22 pathways. Current therapeutic approaches confront significant clinical challenges, including suboptimal treatment responses in subsets of patients, safety risks associated with prolonged pharmacotherapy, and compromised patient adherence. Emerging evidence demonstrates that the OX40-OX40L signaling pathway orchestrates sustained immunoinflammatory responses through its regulatory role in antigen-presenting cell-T cell interactions. Monoclonal antibodies targeting this pathway effectively inhibit pathological immune activation, demonstrating dual clinical benefits of ameliorating cutaneous lesions and maintaining durable remission after treatment cessation. This review systematically elucidates the mechanistic involvement of the OX40-OX40L axis in AD pathogenesis and provides a comprehensive analysis of clinical trial advancements in anti-OX40/OX40L monoclonal antibody therapeutics.

Key words: anti-OX40 monoclonal antibody, anti-OX40L monoclonal antibody, atopic dermatitis, targeted therapy

CLC Number:

R96
R758.2

Fan HUANG, Ziyan DING, Qian ZHOU, Dingyuan HU, Xiaoyan NIE, Rui DING, Yi FANG. Research advances in targeting OX40/OX40L monoclonal antibodies for the treatment of atopic dermatitis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(5): 649-657.

Figures/Tables 1

References 47

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药物名称	靶点	NCT ID	试验阶段	受试者人数	给药方案	疗效结果	安全性结果
Rocatinlimab	OX40	NCT03996223	Ⅰ期	22例（中重度AD患者）	10 mg/kg静脉输注，第1、15、29天给药	第22周：EASI评分下降74.1%，55%达EASI-75，35%实现IGA 0/1	发热（50.0%）、寒战（36.4%）、口腔溃疡（18.2%）等轻度AEs；无SAEs或治疗中止
		NCT03703102	Ⅱb期	274例（中重度AD患者）： 150 mg每4周（52例）； 600 mg每4周（52例）； 300 mg每2周（52例）； 600 mg每2周（54例）；安慰剂（57例）	皮下注射： 150 mg/ 600 mg每4周、300 mg/ 600 mg每2周	第16周： 300 mg每2周组EASI下降61.1%（vs.安慰剂15.0%），EASI-75达54%（vs.11%），31%达vIGA-AD 0/1；第36周EASI下降88.1%，EASI-75达64%	发热（17% vs. 4%）、寒战（11% vs. 0）、头痛（9% vs. 2%）；安全性良好
		NCT05651711	Ⅲ期	726例（中重度AD患者）：rocatinlimab（543例）；安慰剂（183例）	剂量未公布	第24周： EASI-75达32.8% （vs.13.7%），vIGA-AD 0/1达19.3%（vs.6.6%）	无新安全性信号
Telazorlimab	OX40	NCT02683928	Ⅱa期	64例（中重度AD患者）：telazorlimab（46例）；安慰剂（16例）	10 mg/kg静脉输注，第1、29天给药	第71天：EASI下降56%（vs. 38%），EASI-50/75/IGA 0/1分别为76.9%/ 42.3%/23.1%（vs.37.5%/25.0%/ 12.5%）	AEs发生率63% vs. 63%，1例无关SAE （冠状动脉闭塞）
		NCT03568162	Ⅱb期	313例（Part 1，中重度AD患者）：300 mg每2周（76例）； 300 mg每4周（80例）； 75 mg每4周（77例）；安慰剂（80例） 149例（Part 2）：600 mg每2周（75例）；安慰剂（74例）	皮下注射： 300 mg每2周/ 每4周、75 mg 每4周（Part 1）；600 mg每2周（Part 2）	第16周：300 mg/ 600 mg每2周组EASI下降54.4%/59.0%（vs. 34.2%/41.8%），次要终点未达差异；无显著EASI-75或IGA 0/1改善	AEs发生率66.2% vs. 72.5%（Part 1）、65.3% vs. 50.0%（Part 2）；常见AEs为AD恶化（21.9%）、鼻咽炎（8.4%）、上呼吸道感染（13.8%）；SAEs<3%
IMG-007	OX40	NCT05353972	Ⅰ期	44例（健康人）	单次静脉输注	半衰期31天	耐受性良好，无SAEs
		NCT06304740	Ⅰ期	16例（健康人）	单次皮下注射	消除半衰期34.7天，血药浓度可持续18周高于有效浓度	注射部位反应（25% vs. 75%安慰剂）
		NCT05984784	Ⅱa期	13例（AD患者）	300 mg静脉输注（第1、14、28天）	第20周：EASI-50/75/90达成率69%/54%/31%	无SAEs或停药；无发热/寒战等输注反应
Amlitelimab	OX40L	NCT03161288	Ⅰ期	64例健康男性（分8队列，每队列8例，按6:2随机接受KY1005 或安慰剂）	单次剂量组（前3队列）：0.006、0.018、0.05 mg/kg；多次剂量组（后5队列）：负荷剂量：0.15、0.45、1.35、4、 12 mg/kg；维持剂量：第4、8周给予50%负荷剂量	KY1005在0.45 mg/kg及以上的剂量具有中等的药理活性	单次剂量组：AEs发生率83.3% vs. 80%；多次剂量组：80% vs. 80%
		NCT03754309	Ⅱa期	89例（中重度AD患者）： 200 mg（29例）；500 mg（30例）；安慰剂（29例）	静脉注射 200 mg/ 500 mg（第4、8、12周维持剂量50%）	第16周：EASI下降80.12%/ 69.97%（vs. 49.37%），EASI-75达59%/ 52%（vs. 25%），vIGA 0/1达44%/37%（vs. 8%）；停药20周后67%～70%维持应答	AEs发生率47%～62% vs. 69%安慰剂；无剂量依赖性风险
		NCT05131477	Ⅱb期	390例（中重度AD患者）： 62.5 mg （79例）； 125 mg（77例）；250 mg（78例）；250 mg负荷剂量（77例）；安慰剂（79例）	皮下注射 62.5 mg/ 125 mg/250 mg（每4周）	第16周：EASI下降51.6%～ 61.5%（vs. 29.4%）；第52周持续治疗组IGA 0/1达71.9%，停药组57.0%	AEs发生率67.1% vs. 60.3%；常见AEs为鼻咽炎（11.0% vs. 9.0%）、新冠肺炎（7.7% vs. 6.4%）、头痛（6.1% vs. 2.6%）；无发热/ 寒战/口腔溃疡
IBI356	OX40L	NCT06193434	Ⅰ期	计划98例（健康志愿者及AD患者）	剂量未公布（单次/多次递增）	进行中，数据未公布	进行中，数据未公布

药物名称	靶点	NCT ID	试验阶段	受试者人数	给药方案	疗效结果	安全性结果
Rocatinlimab	OX40	NCT03996223	Ⅰ期	22例（中重度AD患者）	10 mg/kg静脉输注，第1、15、29天给药	第22周：EASI评分下降74.1%，55%达EASI-75，35%实现IGA 0/1	发热（50.0%）、寒战（36.4%）、口腔溃疡（18.2%）等轻度AEs；无SAEs或治疗中止
		NCT03703102	Ⅱb期	274例（中重度AD患者）： 150 mg每4周（52例）； 600 mg每4周（52例）； 300 mg每2周（52例）； 600 mg每2周（54例）；安慰剂（57例）	皮下注射： 150 mg/ 600 mg每4周、300 mg/ 600 mg每2周	第16周： 300 mg每2周组EASI下降61.1%（vs.安慰剂15.0%），EASI-75达54%（vs.11%），31%达vIGA-AD 0/1；第36周EASI下降88.1%，EASI-75达64%	发热（17% vs. 4%）、寒战（11% vs. 0）、头痛（9% vs. 2%）；安全性良好
		NCT05651711	Ⅲ期	726例（中重度AD患者）：rocatinlimab（543例）；安慰剂（183例）	剂量未公布	第24周： EASI-75达32.8% （vs.13.7%），vIGA-AD 0/1达19.3%（vs.6.6%）	无新安全性信号
Telazorlimab	OX40	NCT02683928	Ⅱa期	64例（中重度AD患者）：telazorlimab（46例）；安慰剂（16例）	10 mg/kg静脉输注，第1、29天给药	第71天：EASI下降56%（vs. 38%），EASI-50/75/IGA 0/1分别为76.9%/ 42.3%/23.1%（vs.37.5%/25.0%/ 12.5%）	AEs发生率63% vs. 63%，1例无关SAE （冠状动脉闭塞）
		NCT03568162	Ⅱb期	313例（Part 1，中重度AD患者）：300 mg每2周（76例）； 300 mg每4周（80例）； 75 mg每4周（77例）；安慰剂（80例） 149例（Part 2）：600 mg每2周（75例）；安慰剂（74例）	皮下注射： 300 mg每2周/ 每4周、75 mg 每4周（Part 1）；600 mg每2周（Part 2）	第16周：300 mg/ 600 mg每2周组EASI下降54.4%/59.0%（vs. 34.2%/41.8%），次要终点未达差异；无显著EASI-75或IGA 0/1改善	AEs发生率66.2% vs. 72.5%（Part 1）、65.3% vs. 50.0%（Part 2）；常见AEs为AD恶化（21.9%）、鼻咽炎（8.4%）、上呼吸道感染（13.8%）；SAEs<3%
IMG-007	OX40	NCT05353972	Ⅰ期	44例（健康人）	单次静脉输注	半衰期31天	耐受性良好，无SAEs
		NCT06304740	Ⅰ期	16例（健康人）	单次皮下注射	消除半衰期34.7天，血药浓度可持续18周高于有效浓度	注射部位反应（25% vs. 75%安慰剂）
		NCT05984784	Ⅱa期	13例（AD患者）	300 mg静脉输注（第1、14、28天）	第20周：EASI-50/75/90达成率69%/54%/31%	无SAEs或停药；无发热/寒战等输注反应
Amlitelimab	OX40L	NCT03161288	Ⅰ期	64例健康男性（分8队列，每队列8例，按6:2随机接受KY1005 或安慰剂）	单次剂量组（前3队列）：0.006、0.018、0.05 mg/kg；多次剂量组（后5队列）：负荷剂量：0.15、0.45、1.35、4、 12 mg/kg；维持剂量：第4、8周给予50%负荷剂量	KY1005在0.45 mg/kg及以上的剂量具有中等的药理活性	单次剂量组：AEs发生率83.3% vs. 80%；多次剂量组：80% vs. 80%
		NCT03754309	Ⅱa期	89例（中重度AD患者）： 200 mg（29例）；500 mg（30例）；安慰剂（29例）	静脉注射 200 mg/ 500 mg（第4、8、12周维持剂量50%）	第16周：EASI下降80.12%/ 69.97%（vs. 49.37%），EASI-75达59%/ 52%（vs. 25%），vIGA 0/1达44%/37%（vs. 8%）；停药20周后67%～70%维持应答	AEs发生率47%～62% vs. 69%安慰剂；无剂量依赖性风险
		NCT05131477	Ⅱb期	390例（中重度AD患者）： 62.5 mg （79例）； 125 mg（77例）；250 mg（78例）；250 mg负荷剂量（77例）；安慰剂（79例）	皮下注射 62.5 mg/ 125 mg/250 mg（每4周）	第16周：EASI下降51.6%～ 61.5%（vs. 29.4%）；第52周持续治疗组IGA 0/1达71.9%，停药组57.0%	AEs发生率67.1% vs. 60.3%；常见AEs为鼻咽炎（11.0% vs. 9.0%）、新冠肺炎（7.7% vs. 6.4%）、头痛（6.1% vs. 2.6%）；无发热/ 寒战/口腔溃疡
IBI356	OX40L	NCT06193434	Ⅰ期	计划98例（健康志愿者及AD患者）	剂量未公布（单次/多次递增）	进行中，数据未公布	进行中，数据未公布

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