EUCTR2017-003818-11-IT进行中（未招募）1 期
An open-label clinical study to evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate (DMF) in adults with chronic plaque psoriasis (Study DIMESKIN 2). - DIMESKIN 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ALMIRALL SPA
- 入组人数
- 300
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) Informed consent signed and dated personally
- •2) Male or female
- •3) Age = 18 years
- •4) Diagnosis of chronic plaque psoriasis at least 6 months prior to inclusion in the study
- •5) Moderate-to-severe plaque psoriasis defined by at least one of the following criterion:
- •a. PASI = 10
- •b. BSA = 10 and PASI = 5
- •c. DLQI = 10 and PASI = 5
- •6) Good general health or stable medical condition that does not interfere with the conduct of the study, as decided by the Investigator based on medical history, physical examination and laboratory exams
- •7) documented vaccination against hepatitis B or negativity to the HBsAg, HBsAb and HBcAb tests
- •8) negativity to the HCV test
- •9) negativity to the HIV test
- •10) documented vaccination against TBC or negativity to the Elispot TBC test
- •11) indication for a systemic treatment of psoriasis
- •12) wash-out period of at least 4 half-lives in case of previous treatment with biological drugs with anti-psoriatic activity
- •13) known anamnesis for at least 6 months of other previous topical and/or systemic treatments
- •14) Compliance with the following washout periods of the following drugs:
- •- Corticosteroids, Vitamin A analogues, Vitamin D analogues, Coal tar, Salicylic acid preparations (2 weeks)
- •- Systemic treatment (Washout period)
- •- Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy (4 weeks)
- •15) For women of child-bearing potential: negative serum pregnancy test at screening and willingness to use highly effective contraception during the study and for the following 30 days after the end of the treatment.
- •16) For sexually active men with female partners of childbearing age: availability to protected relationships through condom use and availability of the partner(s) to use highly effective contraceptive methods during the study period and for the next 30 days after the end of the treatment
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1) Pregnant or lactating women or women planning to become pregnant
- •2) Diagnosis of guttate, erythrodermic or pustular psoriasis
- •3) Abnormal hematological values such as leukocyte count ¿ 3.000 cells/mm3 or lymphocyte count ¿ 1.000 cells/l
- •4) History of cancer except for non-melanoma skin cancer, in the 5 years prior to enrollment in the study
- •5) Significant gastrointestinal problems (e.g. peptic ulcer, diarrhea, etc.)
- •6) Severe renal failure, with estimated glomerular filtration rate (eGFR) less than 30 ml/min using the CKD-EPI Creatinine Equation*, or using the MDRD (Modification of Diet in Renal Diseases)**, or significant proteinuria (3+ or higher) measured with reactive strips at screening.
- •*Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2009):
- •eGFR = 141 x min(SCr/¿, 1)a x max(SCr /¿, 1)-1.209 x 0.993 Age x 1.018 [if female] x 1.159 [if afro-american]
- •Abbreviations/units:
- •eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2
- •SCr (standardized serum creatinine) = mg/dL
- •¿ = 0.7 (women) or 0.9 (men)
- •a = -0.329 (women) or -0.411 (men)
- •Min = minimum of SCr/¿ or 1
- •Max = maximum of SCr/¿ or 1
- •Age = years
- •** MDRD (Modification of Diet in Renal Diseases)
- •eGFR = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 women) × (1.212 if afro-american)
- •Abbreviations/units:
- •eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2
- •SCr (standardized serum creatinine) = mg/dL
- •Age = years
- •7) Abnormal hepatic enzymes:
- •At least three times the Upper Limit of Normal (ULN/LSN):
- •aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ Serum glutamic pyruvic transaminase (ALT/SGPT), gamma-glutamyl transferase (gamma-GT), alkaline phosphatase (AP)
- •At least two times Upper Limit of Normal (ULN/LSN): bilirubin
- •8) Current infectious diseases
- •9) History of drug or alcohol abuse
- •10) Known HIV-positivity, any other immunosuppressive pathology or treatment with immunosuppressive drugsnota positività ad HBV e/o HCV
- •11) Known positivity to HBV and / or HCV
- •12) active tuberculosis
- •13) known hypersensitivity to the components of the DMF
- •14) Known lactose intolerance
- •15) previous enrollment in this study or participation in other clinical-pharmacological studies within the previous 30 days (or 5 half-lives, depending on which interval is the longest).
- •16) previous treatment with anti-psoriatic biological drugs without a wash-out period of at least 4 half-lives
- •17) inability to meet the study requirements or the Investor's negative judgment about participation in the study..
研究者
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