EUCTR2018-001926-25-DE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
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
- •b)Psoriatic arthritis and is currently requiring systemic immunosuppressive medical treatment for treatment of such conditions
- •2)Infectious/Immune-related Exclusions
- •a)History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day1
- •b)History of serious bacterial, fungal, or viral infection requiring hospitalization and IV antimicrobial treatment within 60 days prior to Day1
- •c)Untreated bacterial infection within 60 days prior to Day1
- •d)Ongoing evidence of chronic, bacterial infection
- •e)History of proven infection of a joint prosthesis
- •f)Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study treatment
- •g)Presence of herpes zoster lesions at Screening or Day1
- •h)History of serious herpes zoster or serious herpes simplex infection
- •i+j)Evidence of, or test positive for HBV and HCV at Screening
- •k)Positive for HIV-1 and -2 Ab at Screening
- •l)History of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status
- •3)Any of the following TB criteria
- •a)History of active TB prior to Screening
- •b)Signs or symptoms of active TB during screening
- •c)Any imaging of the chest showing evidence of current active or history of active pulmonary TB
- •d)Latent TB infection defined as positive IFN gamma release assay at Screening, in the absence of clinical manifestations
- •4)Medical History and Concurrent Diseases
- •a)Any major surgery within 8 weeks prior to Day1, or any planned surgery for the first 52 weeks of the study
- •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) >160mm Hg or diastolic BP >100mm Hg
- •h)Class III or IV congestive heart failure
- •i)Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
- •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 Day 1, or is clinically deemed to have a 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 4 weeks prior to Day1
- •n)Used leflunomide within 6 months prior to Day1
- •o)Used opioid analgesics within 4 weeks prior to Day1
- •p)Received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of any study medication
- •q)Used any strong CYP450 inducers within 4 weeks prior to Day1
- •r)Received phototherapy within 4 weeks prior to Day1
- •s)Used topical medications/treatments that could affect psoriasis evaluation within 2 weeks prior to Day1
- •t)Use of shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitamin D3 analogues within 2 weeks prior to Day1
- •u)Received an experimental antibody or experimental biologic therapy within the previous 6 months, OR received any other experimental therapy or new investigational agent
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