EUCTR2018-001926-25-PL进行中（未招募）1 期
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque 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
- 600
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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •1) Signed Written Informed Consent
- •a) Subjects must be willing to participate in the study and sign the informed consent form (ICF)
- •2) Type of Subject and Target Disease Characteristics
- •a) Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator
- •b) Deemed by the investigator to be a candidate for phototherapy or systemic therapy
- •c) =10% of BSA involvement at Screening Visit and Day 1
- •d) Psoriasis Area and Severity Index (PASI) score =12 and static Physician’s Global Assessment (sPGA) =3 at Screening Visit and Day 1
- •3) Age and Reproductive Status
- •a) Men and women aged =18 years at the time of Screening Visit
- •b) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening Visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug
- •c) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period
- •d) Women of childbearing potential must agree to use correctly a highly effective method(s) of contraception for the duration of treatment (52 weeks) with study drug(s) BMS-986165
- •plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug).
- •WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in this protocol
- •e) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment(s) plus 5 half-lives of the study treatment (3 days) for a total of 3 days post-treatment completion. In addition, male subjects must be willing to refrain from sperm donation during this time
- •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 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1)Target Disease Exceptions
- •a)Has nonplaque psoriasis at Screening or Day1
- •2)Infectious/Immune-related Exclusions
- •a)History or evidence of outpatient active infection and/or febrile illness within 7days prior to Day1
- •b)History of serious bacterial, fungal, or viral infection requiring hospitalization and IVantimicrobial treatment within60days prior toDay1
- •c)Any untreated bacterial infection within60days prior toDay1
- •d)Any ongoing evidence of chronic, bacterial infection
- •e)Any history of proven infection of a joint prosthesis
- •f)Received live vaccines within60days prior toDay1, or plans to receive a live vaccine during the study, or within 60days after completing study treatment
- •g)Presence of herpes zoster lesions atScreening orDay1
- •h)History of serious herpes zoster or serious herpes simplex infection
- •i+j)Evidence of, or test positive for HBV and HCV atScreening
- •k)Positive forHIV-1 and -2Ab atScreening
- •l)Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status
- •3)Any of the followingTBcriteria
- •a)History of active TBprior to Screening
- •b)Signs or symptoms of active TBduring screening
- •c)Any imaging of the chest showing evidence of current active or history of active pulmonary TB
- •d)Latent TBinfection defined as positive IFNgamma release assay at Screening, in the absence of clinical manifestations
- •4)Medical History and Concurrent Diseases
- •a)Any major surgery within 8weeks prior to Day1, or any planned surgery for the first 52weeks of the study
- •b)Has donated blood >500mL within 4weeks prior to Day1, or plans to donate blood during the course of the study donate blood during the course of the study
- •c)Drug or alcohol abuse, as determined by the investigator, within 6months prior to Day1
- •d)Medical marijuana
- •e)Major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk of participation
- •f)Unstable cardiovascular disease
- •g)Uncontrolled arterial hypertension characterized by a systolic blood pressure (BP)>160mmHg or diastolic BP>100mmHg
- •h)ClassIII or IVcongestive heart failure
- •i)Has cancer or hist. of cancer or lymphoproliferative disease within the previous 5years
- •j)Significant/uncontrolled neuropsychiatric illness judged as clinically significant by the investigator during Screening or at Day1 OR Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts at Screening or at Day1, or is clinically deemed to have suicide risk
- •k)Prior exposure to investigational product (ie BMS-986165 or apremilast)
- •l)If the subject has received biologics previously, exclusion criteria for washout will apply
- •m)Received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressants within 4weeks prior to Day1
- •n)Used leflunomide within 6months prior to Day1
- •o)Used opioid analgesics within 4weeks prior to Day1
- •p)Received lithium, antimalarials, or intramuscular gold within 4weeks of the first administration of any study medication
- •q)Used any strong CYP450 inducers within 4weeks prior to Day1
- •r)Received phototherapy within 4weeks prior to Day1
- •s)Used topical medications/treatments that could affect psoriasis evaluation within 2weeks prior to Day1
- •t)Use of shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitamin D3analogues within 2weeks prior to Day1
- •u)Received an experimental antibody or experimental biologic therapy within the p
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