EUCTR2017-001615-36-DE进行中（未招募）1 期
A phase II, randomized, parallel group, placebo-controlled, double-blinded, dose-finding study to evaluate efficacy, safety, tolerability, and pharmacokinetics of ABY-035 in subjects with moderate-to-severe plaque psoriasis - AFFIRM-35 Study
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
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Willingness and capability of providing written Informed Consent
- •2. Male or female, aged 18-75 years (inclusive), and of any origin
- •3.Diagnosed with plaque psoriasis of at least 6 months prior to Screening, suitable for systemic treatment or phototherapy, and has stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before randomization). Subjects with low active Psoriatic Arthritis may be included if they had not received systemic treatment within the last 12 months
- •4. Having precedent failure, intolerance and/or contraindication to at least two standard therapies for moderate-to-severe plaque psoriasis
- •(systemic therapy and/or phototherapy) and previous insufficient disease control of topical therapy (e.g. corticosteroids, vitamin D derivatives, cignolin/dithranol)
- •5. Moderate-to-severe plaque psoriasis at Screening and at Baseline as defined by:
- •i. Psoriasis involving =10% BSA
- •ii. PASI score of = 12
- •iii. sPGA score of = 3
- •6. Willingness and capability of using adequate contraceptive measures from Screening visit until the Pregnancy follow-up Visit:
- •i. Female subject of childbearing potential using a highly efficient method of contraception OR female subjects 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])
- •ii. Male subject, and their female partner of childbearing potential, using a highly efficient method of contraception
- •iii. Adequate contraceptive method defined as:
- •a. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner)
- •b. 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])
- •7. Willingness and capability of complying with all study procedure requirements, as per the Investigator’s judgment
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Current forms of psoriasis other than chronic plaque-type
- •2. Current drug induced psoriasis
- •3. History of hypersensitivity or allergy to the IMP or its excipients
- •4. History of recurrent or medically important infections in the last 12 months that required medical/pharmaceutical intervention
- •5. Clinically significant candida infection requiring systemic treatment within last 12 months
- •6. Clinically significant skin infection with Staphylococcus aureus requiring systemic treatment within the last 12 months
- •7. History of 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. History of or current relevant autoimmune diseases other than psoriasis
- •9. Diagnosis of Inflammatory Bowel Disease requiring treatment within the past 12 months
- •10. Clinically significant heart condition which is not well controlled by current therapy, as assessed by the Investigator
- •11. Underlying conditions which in the opinion of the Investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
- •12. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the subject from adhering to the protocol or completing the study per protocol
- •13. Current uncontrolled arterial hyper- or hypotension as evidenced by measured blood pressure values at Screening (after 15 min in supine position) outside the following ranges:
- •-Systolic blood pressure: =90 mmHg or > 140 mmHg
- •-Diastolic blood pressure: =50 mmHg or =95 mmHg
- •14. Alanine aminotransferase or aspartate aminotransferase level =2.5 times the upper limit of normal at Screening
- •15. Estimated Glomerular Filtration Rate <60 mL/min/1.73 m2 according to the CKD-EPI equation
- •16. Positive test for subclinical / latent tuberculosis infection at Screening
- •17. Positive test for human immunodeficiency virus, hepatitis B or hepatitis C at Screening:
- •-HIV antibody (any test)
- •-HBV surface antigen
- •-Anti-HCV antibody
- •18. Women who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding
- •19. Evidence or indication of drug and/or alcohol abuse or dependence, according to the judgment of the Investigator
- •20. Recent previous exposure to systemic psoriasis treatments within the following weeks prior to randomization: biological therapies (e.g. ustekinumab [16 weeks], adalimumab, alefacept, infliximab [12 weeks], etanercept [6 weeks], experimental biological products [6 months or 5 half-lives, whichever is longer]); immunosuppressive agents [4 weeks]; other medications affecting the immune function [4 weeks]; rituximab [52 weeks]; or other systemic psoriasis treatments [4 weeks]
- •21. Treatment with topical agents that could affect psoriasis activity within 2 weeks of randomization. Topical therapy in selected areas such as the groin or axillar region with mild corticosteroids (European classification 1) is not excluded
- •22. Prior exposure to systemic psoriasis treatments with anti-IL-17 biological therapies
- •23. Photochemotherapy, phototherapy, or blue light therapy within 4 weeks of randomization
- •24. Use of any prescribed or non-prescribed systemic or topical medication within 7 days of randomization that, in the opinion of the Investigator, may affect the study assessments or
研究者
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