EUCTR2018-001925-24-IT进行中（未招募）1 期
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis - Efficacy, Safety, and Durability of Response of BMS-986165 versus Placebo and Active Comparator in S
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
- 1,000
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 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1)Target Disease Exceptions
- •a)Has non-plaque psoriasis at screening or Day1
- •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)Any untreated bacterial infection within 60 days prior to Day1
- •d)Any ongoing evidence of chronic, bacterial infection
- •e)Any history of proven infection of a joint prosthesis
- •f)Received live vaccines within 60 days prior to Day1, 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 or HCV at screening
- •k)Positive for human HIV-1 and -2 Ab at Screening
- •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 following TB criteria:
- •a)History of active TB prior to screening visit
- •b)Signs or symptoms of active TB during screening
- •c)Any imaging of the chest obtained during the screening period, or anytime within 6 months prior to screening showing TB
- •d)Latent TB infection defined as positive IFNg 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
- •b)Has donated blood >500 mL within 4 weeks prior to Day1, or plans to donate blood during the course of the study
- •c)Drug or alcohol abuse within 6 months prior to Day1
- •d)Medical marijuana
- •e)Any major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk to the subject's participation
- •f)Unstable cardiovascular disease, defined as a recent clinical cardiovascular event in the last 3 months prior to screening, or a cardiac hospitalization within 3 months prior to screening
- •g)Has 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)Has cancer or history of cancer or lymphoproliferative disease within the previous 5 years
- •j)Any uncontrolled neuropsychiatric illness judged as clinically significant during screening or at Day1 OR Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts
- •k)Prior exposure to IMP
- •l)If the subject has received biologics previously, certain exclusion criteria for washout will apply
- •m) Has received systemic non-biologic psoriasis medications and/or any systemic immunosuppressants therapy within 4 weeks prior to Day1
- •n)Has used leflunomide within 6 months prior to Day1
- •o)Has used opioid analgesics within 4 weeks prior to Day1
- •5)Physical and Laboratory Evaluations
- •6)Allergies and Adverse Drug Reactions
- •a)History of any significant drug allergy
- •7)Other Exclusion Criteria
- •a)Prisoners or subjects who are involuntarily incarcerated
- •b)Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
- •Please, refer to the Protocol for the full list of exclusion criteria
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