EUCTR2013-001885-41-DE进行中（未招募）不适用
A multi-center, double-blinded, randomized, placebo-controlled, phase II study to evaluate the safety, tolerability and efficacy of a topical application of DLX105 onto lesional skin in patients with mild-to-moderate psoriasis vulgaris
Delenex Therapeutics AG0 个研究点目标入组 54 人开始时间: 2013年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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
- •Patients eligible for inclusion in this trial have to fulfil all of the following criteria:
- •1.Signed and dated informed consent prior to initiation of any study procedures.
- •2.Male or female Caucasian aged 18-75 years.
- •3.Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI =15).
- •4.Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI =15) aged 18-75 years who must have at least two psoriasis lesions of >9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score =8.
- •5.Affected body surface area (BSA) =10%.
- •6.Negative pregnancy test for females of child-bearing potential (pre-menopausal,
- •<2 years post-menopausal, not surgically sterile).
- •7.Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients who fulfil one or more of the following criteria will not be eligible for inclusion in this trial:
- •1.Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
- •2.Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
- •3.Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
- •a.Biological agents, e.g. adalimumab, etanercept, infliximab, ustekinumab, alefacept (12 weeks)
- •b.Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
- •c.Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
- •d.Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
- •e.Topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogues or retinoids within 14 days prior to baseline
- •f.Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
- •4.Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
- •5.History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
- •6.Active systemic infections (other than common cold) during the two weeks before randomization
- •7.Positive test for hepatitis B or C at screening
- •8.Positive test for HIV at screening
- •9.History or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratosis, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •10.History of severe hypersensitivity to any human or humanized biological agents
- •11.Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study.
- •12.Any clinically significant abnormal laboratory tests at screening
- •13.Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal at screening
- •14.History of moderate or severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- •15.Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
- •16.History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
- •17.Patients who had live vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
- •18.History of hypersensitivity to any of the excipients of the study drugs or to excipients of similar chemical classes
- •19.Pregnant or nursing (lactating) women, where pregnancy is d
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