NCT07137598招募中2 期
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 70
- 主要终点
- Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
研究概览
简要总结
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has moderate to severe active RA defined by the presence of >=6 swollen joints and >=6 tender joints at screening and baseline (based on 66/68-joint count)
- •Diagnosis of RA for >=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
- •Demonstrated an inadequate response or loss of response to or intolerance to >=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
排除标准
- •Have failed more than two TNF inhibitors or JAK inhibitors
- •Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- •Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
- •Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
- •History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
- •Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
- •History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
- •Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- •Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
- •History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
- •Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
- •History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
- •History of organ transplant
- •Any identified confirmed congenital or acquired immunodeficiency
- •Abnormal laboratory values and liver function test
研究组 & 干预措施
Afimkibart Group I
Experimental
Participants will receive afimkibart via subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Afimkibart Group II
Experimental
Participants will receive afimkibart via SC injection.
干预措施: Afimkibart (Drug)
Placebo
Placebo Comparator
Participants will receive afimkibart matched placebo via SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
时间窗: Baseline, At Week 14
次要结局
- Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)(At Week 14)
- Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Tender Joint Count (TJC)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Patient's Global Assessment of Arthritis Pain-Visual Analog Scale (PGA Arthritis Pain-VAS)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Patient's Global Assessment of Disease Activity-Visual Analog Scale (PaGADA-VAS)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI)(Baseline, At Week 14 and Week 24)
- Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP)(Baseline, At Week 14 and Week 24)
- Change from Baseline in ACR20, ACR50 and ACR70 Response Rate(Baseline, At Week 24)
- Change from Baseline in Simplified Disease Activity Index (SDAI) Score(Baseline, At Week 14 and Week 24)
- Change from Baseline in Clinical Disease Activity Index (CDAI) Score(Baseline, At Week 14 and Week 24)
- Change from Baseline in Short Form-36 Health Survey (SF-36) Score(Baseline, At Week 14 and Week 24)
- Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score(Baseline, At Week 24)
- Percentage of Participants With Adverse Events (AEs)(Up to Week 38)
- Serum Concentration of RO7790121 at Specified Timepoints(Up to Week 38)
- Percentage of Participants With Anti-Drug Antibodies(Baseline, Up to Week 38)
研究者
研究点 (70)
Loading locations...
相似试验
进行中（未招募）
2 期
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerNCT05287113Incyte Biosciences International Sàrl176
进行中（未招募）
2 期
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT04895696Beeline Medicines Corporation248
Unknown
2 期
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP PatientsChronic Myelogenous LeukemiaNCT02511340Jiangsu Hansoh Pharmaceutical Co., Ltd.167
已完成
2 期
Fedratinib in Combination With NivolumabSecondary MyelofibrosisPrimary MyelofibrosisNCT05393674Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest30
已完成
3 期
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT00095147Bristol-Myers Squibb431