EUCTR2019-003405-94-CZ进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled, dose-finding clinical trial inpatients with active psoriatic arthritis to investigate efficacy, tolerability, safety,pharmacokinetics and immunogenicity of ABY-035
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Affibody AB
- 入组人数
- 135
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
- 性别
- All
入选标准
- •1. Patient who has given his / her signed declaration of consent and data protection declaration
- •2. At least 18 years and less than 75 years of age at Screening visit
- •3. Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of =3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
- •4. Active psoriatic arthritis defined by:
- •a. =3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
- •b. =3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
- •5. Precedent failure or insufficient treatment response to at least one of the following psoriatic arthritis treatments:
- •b. csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A)
- •c. TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
- •6. Rheumatoid factor (RF) and anti-CCP antibody negative
- •7. Presence or history of plaque psoriasis
- •8. For females of childbearing potential only: Negative serum human chorionic gonadotropin (hCG) test at Screening visit
- •9. Willingness and capability of using adequate contraceptive methods from the Screening visit until 14 weeks after the last ABY-035 dose:
- •a. Female of childbearing should use a highly efficient method of contraception (see 9c) but this is not necessary for females of non-childbearing potential permanently sterilized or post-menopausal [i.e. at least 12 consecutive months with amenorrhea without other known or suspected medical cause])
- •b. Male who has a female partner of childbearing potential, should use a highly efficient method of contraception (see 9c)
- •c. Adequate contraceptive method defined as:
- •i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone
- •implants, hormone injections, some intrauterine devices, or vasectomized partner)
- •ii. The use of two methods of contraception (e.g. one barrier method [condom,
- •diaphragm or cervical / vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants])
- •10. Willingness and capability of complying with all trial procedure requirements, as per the investigator’s judgement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Underlying conditions which, in the investigator’s opinion, significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
- •2. History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
- •3. History of or current fibromyalgia or pain syndrome
- •4. Uncontrolled inflammatory bowel disease
- •5. Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit, e.g. due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections, that required medical / pharmaceutical intervention (i.e. prescription of antibiotics and / or hospitalization)
- •6. Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
- •7. History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence)
- •8. Insufficiently controlled heart failure, as assessed by the investigator
- •9. Current uncontrolled arterial hyper- or hypotension
- •Laboratory examinations and body measurements:
- •10. Positive test for subclinical / latent tuberculosis infection (i.e. positive QuantiFERON-TB® Gold test or equivalent product) or chest X-ray suggestive of tuberculosis at Screening visit
- •11. Positive test for human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at Screening visit:
- •a. HIV antibody (any test)
- •b. HBV surface antigen (HBVsAg)
- •c. Anti-HCV antibody (HCV Ab)
- •12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) at Screening visit
- •13. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening visit
- •14. Body mass index (BMI) =40 kg/m2 or <16 kg/m2
- •Medication, drug use and special behavioral patterns
- •15. Previous exposure to ABY-035 or any other interleukin-(IL-)17i or IL-17 receptor inhibitor (e.g. secukinumab, ixekizumab, brodalumab)
- •16. History of hypersensitivity or allergy to ABY-035 or its excipients
- •Refer to Protocol for full list of Exclusion criteria
研究者
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