EUCTR2017-004611-38-CZ进行中（未招募）1 期
A phase 2b randomized, double-blind, placebo controlled, multi-center 12-week study with an additional 40-week follow-up assessment of efficacy, safety and tolerability of M1095 in subjects with moderate to severe chronic plaque-type psoriasis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. Ambulatory male and female subjects between 18 and 75 years of age at time of consent.
- •2. Subject has had stable moderate to severe plaque-type psoriasis for at least 6 months prior to randomization (e.g. no morphology changes or significant flares of disease activity in the opinion of the investigator).
- •3. Subject must be considered, in the opinion of the investigator, not adequately controlled by photo, topical or previous systemic treatments and a candidate for systemic biologic therapy.
- •4. Subject has IGA =3, involved body surface area (BSA) =10% and PASI =12 at screening and at baseline.
- •5. Subject is in the opinion of the investigator able to comply with the study procedures.
- •6. Following verbal and written information about the study, subject must provide signed and dated informed consent before any study related activity is carried out.
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of psoriasis (Note: psoriatic arthritis is NOT exclusionary.)
- •2. Subject has drug-induced psoriasis.
- •3. Other medical conditions:
- •a. At the time of consent, subject has a planned in-patient surgical intervention between baseline and the Week 52 evaluation.
- •b. Subject has an active infection or history of infections as follows:
- •i. Any active infection for which systemic anti-infectives were used within 28 days prior to randomization.
- •ii. A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to randomization.
- •iii. Any history of bone infection requiring surgical intervention and/or intravenous antibiotics.
- •iv. Recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
- •c. Subject has active tuberculosis.
- •d. Subject has a positive QuantiFERON®-TB Gold test for tuberculosis at screening, or the first test and repeat test are both indeterminate, unless
- •i) subject has a known history of latent TB and has completed a course of treatment or
- •(ii) subject has received sufficient treatment for latent TB to allow concomitant treatment with a biological therapy as per local guidelines (note these subjects must continue their concomitant latent TB treatment to completion while participating in the study). If these subjects are outside of the screening window (>28 days since consent) when they become eligible to participate, they should be fully re-screened for the study.
- •e. Subject has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator places the subject at unacceptable risk for receiving an immunomodulatory therapy.
- •f. Subject has known history of inflammatory bowel disease.
- •g. Subject with known chronic liver disease or tests positive for hepatitis B virus (HBV) infection or has antibodies to hepatitis C virus (HCV) at screening.
- •h. Subject has antibodies to human immunodeficiency virus (HIV) at screening.
- •i. Subject has history of heart failure, myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization.
- •j. Subject has uncontrolled hypertension characterized by two blood pressure measurements separated by at least 15 minutes with systolic >160mmHg or diastolic >100mmHg.
- •k. Subject has clinically significant electrocardiogram (ECG) abnormalities on centrally read ECG.
- •l. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- •m. Subject has history of malignancy within 5 years EXCEPT cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma which has been treated and considered cured.
- •n. Subject has any concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
- •4. Subject has laboratory abnormalities at screening, including any of the following:
- •a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x the upper limit of normal (one retest is allowed for aminotransferase abnormalities.)
研究者
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