EUCTR2017-004611-38-BG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
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 a repeat test are both indeterminate,
- •(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 rescreened
- •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
- •h. Subject has antibodies to human immunodeficiency virus (HIV) at
- •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
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研究者
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