CTIS2023-504564-42-00招募中1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis - ANB030-203
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject is an adult male or female = 18 years when the subject signs the ICF., A female subject who is a women of childbearing potential (WOCBP; defined below) must have a negative serum pregnancy test result at the Screening visit (Visit 1) and a negative urine pregnancy test result on Day 1 (Visit 2) prior to administration of study treatment, and must agree to use a highly effective method of birth control from the first dose of study treatment on Day 1 until at least 24 weeks after the last dose of study treatment. A WOCBP is defined as a woman who is between menarche and at least 12 months postmenopausal and who is not surgically or chemically sterilized (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; tubal ligation or occlusion are not considered acceptable methods of surgical sterilization so do not qualify women as of non-childbearing potential). Postmenopausal is defined as amenorrheic for at least 12 months, and, if aged < 60 years, have a serum follicle-stimulating hormone (FSH) level > 20 mIU/L. Women who are taking hormone replacement therapy do not have to have FSH assessments, but the amenorrhea before starting hormone replacement therapy must have been naturally occurring (i.e., spontaneous) and accompanied by an appropriate clinical profile (e.g., age appropriate with a history of vasomotor symptoms). Note: If a female subject’s childbearing potential changes after start of the study (e.g., a woman who is not heterosexually active becomes active or a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control as soon as possible and until at least 24 weeks after the last dose of study treatment., Female subjects must agree to refrain from donating ova during the study and for at least 24 weeks after the last dose of study treatment., Male subjects must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and use condoms plus spermicide from the first dose of study treatment on Day 1 until at least 150 days (duration of relevant exposure plus the duration of sperm cycle) after the last dose of study treatment if sexually active with a female partner who is a WOCBP. Male subjects should also be advised of the benefit for a female sexual partner who is a WOCBP to use an additional highly effective method of contraception as condoms may occasionally fail to prevent pregnancy, Male subjects must agree to refrain from donating sperm during the study and for at least 150 days (duration of relevant exposure plus the duration of sperm cycle) after the last dose of study treatment., Subject is willing to participate, is not prohibited from participating by any local laws or regulations (e.g. persons under court protection, persons not affiliated to a social security system, protected adults), and is capable of giving voluntary written informed consent, which must be personally signed and dated by the subject and obtained prior to the initiation of any Screening or study-specific procedures., Subject is willing to comply with all study procedures and lifestyle considerations and must be available for the duration of the study., Subject has a clinical diagnosis of active RA based on the ACR/EULAR 2010 classification criteria (Aletaha 2010) for =3 months before Day 1., Subject is judged by the Investigator to be in good health (except for RA) based on the subject’s medical history
排除标准
- •Subject has history of inflammatory joint disease other than RA including, but not limited to, gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis (e.g., ankylosing spondylitis, nonradiographic axial spondyloarthritis), reactive arthritis, overlap connective tissue disease syndromes, scleroderma, polymyositis, dermatomyositis, or any arthritis with onset prior to age 17 years. A subject with a history of Sjogren's Syndrome secondary to RA may be enrolled in the study., Subject has signs, symptoms, or current diagnosis of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (other than RA), or psychiatric conditions or metabolic disturbances, as determined by the Investigator, at Screening or Day 1., Subject had a cardiac hospitalization, myocardial infarction, or unstable cardiovascular disease (e.g., unstable angina, rapid atrial fibrillation, or clinically significant arrythmia), as determined by the Investigator, within 3 months of Day 1., Subject meets New York Heart Association criteria for Class III or higher congestive heart failure at Screening or Day 1., Subject has as a history of lymphoproliferative disease (including lymphoma) or monoclonal gammopathy of undetermined significance, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g., lymphadenopathy or splenomegaly) as determined by the Investigator., Subject has a history of malignancy or cervical intraepithelial dysplasia within 5 years before Day 1 (except for squamous and basal cell carcinomas of the skin). See Appendix 11 for region-specific requirements., Subject has any factors that, in the Investigator’s opinion, would predispose the subject to develop an infection, including, but not limited to: a. Subject has any evidence of active infection (e.g., bronchopulmonary, urinary, or gastrointestinal) that required systemic antibacterial, antifungal, or antiviral therapy within 4 weeks before Day 1.; b. Subject has any open, draining, or infected skin wounds or ulcers within 3 months before Day 1; c. Subject has a history of chronic or recurrent infectious disease, including but not limited to, chronic renal infections, chronic chest infections (e.g., bronchiectasis), recurrent urinary tract infections (e.g., recurrent pyelonephritis or chronic nonremitting cystitis), and deep fungal infections (e.g., mucocutaneous candidiasis) within 6 months before Day 1; d. Subject has a history of an opportunistic infection (e.g., Pneumocystis carinii, aspergillosis, or mycobacteria other than TB) or parasitic infections (e.g., helminths, protozoa, Trypanosoma cruzi) within 12 weeks before Day 1.; e. Subject has a history of recurrent herpes zoster or 1 or more episodes of disseminated herpes zoster.; f. Subject has a history of 1 or more episodes of disseminated herpes simplex (including eczema herpeticum)., Subject has a known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status (e.g., previous recipient of an organ transplant which requires continued immunosuppression, history of splenectomy)., Subject had surgery within 4 weeks of Day 1 or plans to have surgery that, in the opinion of the Investigator, would interfere with the study., Subject has a history of clinically significant drug or alcohol abuse in the 12 months before Day 1, or o
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