EUCTR2007-003922-70-DE进行中（未招募）不适用
ncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
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.Adult patient with (at least 6 months or longer) moderate to severe palmoplantar pustular psoriasis with or without psoriasis at other sites
- •2.PGA rating of moderate (4), severe (5) or very severe (6) for palmoplantar pustular psoriasis with at least ten fresh pustules at screening visit and baseline
- •3.Age 18 to 75 years
- •4.Body weight £125 kg
- •5.Naïve to efalizumab treatment
- •6.Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (Study Day 0 = SD 0) is required, if not indicated otherwise. Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0)
- •7.Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0)
- •8.Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of six months is required for these agents prior to receiving the first dose of study drug (SD 0)
- •9.Treatment regimens of b blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0)
- •10.No required vaccination (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).
- •11.Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
- •12.Willingness to participate in photo documentation
- •13.For women of childbearing potential: Use of an acceptable method of contraception (implants, oral contraceptives, intrauterine device, sterilization or sterilized partner) to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and up to 3 months after the last dose of efalizumab
- •14.Agreement to participate in the study
- •15.Signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Guttate, erythrodermic or chronic plaque psoriasis as sole or predominant form of psoriasis
- •2.History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- •3.History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded
- •4.History of opportunistic infections (e.g., systemic fungal infections, parasites)
- •5.History of or ongoing active tuberculosis (TB) or other serious infections
- •6.History of clinically significant thrombocytopenia, bleeding disorders or hemolytic anemia
- •7.Previous exposure to efalizumab
- •8.Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)
- •9.Application of systemic treatments within 3 months prior to receiving the first dose of study drug (SD 0)
- •10.Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within one month prior to receiving the first dose of study drug (SD0)
- •11.UV/PUVA treatment within 1 month prior to receiving first dose of study drug (SD 0)
- •12.Application of any investigational drug or treatment less than six months ago prior to receiving the first dose of study drug (SD 0)
- •13.Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)
- •14.Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
- •15.Diagnosis of hepatic cirrhosis, regardless of cause or severity
- •16.Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- •17.History of drug abuse within the last 5 years
- •18.History of seropositivity for human immunodeficiency virus (HIV)
- •19.History of seropositivity for hepatitis B or C virus
- •20.WBC count <4,000µ/L or >14,000/µL
- •21.Hematocrit (HCT) <30% or hemoglobin (Hgb) level <11 g/dL
- •22.Platelet count <150,000 cells/µL
- •23.Hepatic enzymes >3 times the upper limit of normal
- •24.Serum creatinine >2 times the upper limit of normal
- •25.Pregnancy or lactation
- •26.Any medical condition that, in the judgment of the investigator, would jeopardize the patient’s safety following exposure to study drug
- •27.Patient unwilling or unable to follow the protocol requirements
研究者
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