EUCTR2022-002633-34-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alumis Inc.
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able and willing to provide signed informed consent to participate in this study
- •2. Males or females, age 18-75 years, inclusive, at the Screening Visit
- •3. Total body weight >40 kg (88 lb), BMI > 18 kg/m2
- •4. Diagnosis of plaque psoriasis for =6 months
- •5. Plaques covering =10% of body surface area (BSA)
- •6. Psoriasis area severity index score (PASI) score =12 and static Physician’s Global Assessment (sPGA) score =3
- •7. Women of childbearing potential (WOCBP) must agree to adhere to highly effective methods of contraception for the entirety of the study and for 30 days after the last dose of study drug
- •8. Males who are sexually active with WOCBP must agree to use highly effective methods of contraception for the entirety of the study and for 90 days after the last dose of study drug
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic, drug induced)
- •2. Diagnosis of immune-mediated conditions that are commonly associated with psoriasis (e.g., uveitis, inflammatory bowel disease) or other inflammatory skin conditions that may interfere with the study assessment
- •3. Patients with psoriatic arthritis who are receiving systemic (oral, SC, IM or IV) immunosuppressant medications (including corticosteroids, immunosuppressant biologics) or who has or is expected, in the opinion of the investigator, to develop unstable disease.
- •Patients who are receiving a stable therapeutic regimen for their psoriatic arthritis that does not include immunosuppressants (e.g. NSAIDs) may be included in the study
- •4. Pregnant, lactating, or planning to get pregnant during the study period
- •5. Has used topical medications/treatments that could affect psoriasis evaluation within 2 weeks of the first administration of study drug
- •6. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluation within 4 weeks of Study Day 1
- •7. Has received any therapeutic agent targeted to: IL-12or IL-23 within 6 months, IL-17 within 4 months, or any TNFa inhibitor(s) within 2 months of first administration of study drug
- •8. Is currently receiving or has received any systemic immunosuppressants or immunomodulatory drugs (e.g., methotrexate, cyclosporine) within 4 weeks of the first administration of study drug or 5 half-lives whichever is longer
- •9. Has received agents that modulate B cells (e.g., rituximab, ocrelizumab) within 6 months of first administration of study drug
- •10. Has received agents that modulate T cells (e.g., abatacept, alemtuzumab) within 3 months of first administration of study drug
- •11. Has received JAK inhibitors (e.g., baricitinib, tofacitinib) or TYK2 inhibitors within 4 weeks of first administration of study drug
- •12. History of lack of clinical response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 (e.g., ustekinumab, risankizumab, secukinumab, ixekizumab) at approved doses after at least 3 months of treatment
- •13. History of lack of clinical response, in the Investigator’s opinion, to 2 or more biologic therapies at approved doses after at least 3 months of treatment
- •14. Has received any investigational agent, within 30 days or 5 half-lives (whichever is longer) of any study drug or is currently enrolled in an investigational study
- •15. Is currently receiving proton pump inhibitors such as omeperazole or esomeprazole. It is acceptable to substitute a histamine 2 receptor blocking drug or oral antacids prior to Study Day 1
- •16. Patients with QTcF >450 msec (males) or >470 msec (females) at screening
- •17. Unstable cardiovascular disease, defined as a recent clinical deterioration (e.g., unstable angina, rapid atrial fibrillation) or a cardiac hospitalization within the last 3 months
- •Patients requiring medications to treat underlying stable chronic cardiovascular disease, including but not limited to ß-blockers, should be on a stable dose for at least 4 weeks before Study Day 1
- •18. Active herpes viral infection, including herpes simplex 1 and 2 and herpes zoster identified on examination and/or medical history within 2 months of administration of study drug
- •19. Patients with hepatitis C virus (HCV), or hepatitis B virus (HBV) or human immunodeficiency virus (HIV) or active or inadequately treated latent tuberculosis (TB) infection at screening
- •20. Has any of the fol
研究者
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