ACTRN12619000395134已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Pharmacokinetics and Preliminary Efficacy of CBP-201 in Adult Patients with Moderate to Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Patient able to read and understand, and willing to sign the informed consent form (ICF)
- •2. Male or female, aged 18 to 65 years (inclusive) at time of Screening
- •3. Willing and able to comply with clinic visits and study-related procedures
- •4. Have AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka, that has been present for at least 1 year before the Screening visit
- •5. Eczema Area and Severity Index (EASI) score greater than or equal to 12 at the Screening and Baseline visits
- •6. Investigator Global Assessment (IGA) score greater than or equal to 3 at the Screening and Baseline visits
- •7. Greater than or equal to 10% body surface area (BSA) of AD involvement at the Screening and Baseline visits
- •8. History of an inadequate response, in the judgement of the Investigator, to AD treatment with a topical regimen of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors within 1 year of the Screening visit
- •9. Patients must have applied a bland emollient twice a day to affected areas for at least 7 days before the Baseline visit and be willing to continue for the duration of the study
- •10. Male patients must abstain from heterosexual activities or agree to use a condom through 90 days after the final dose of study drug. Women of child-bearing potential (WOCBP) must abstain from heterosexual activities or agree to use effective contraception.
- •Effective contraception for males and/or WOCBP includes:
- •a. Blockage methods – spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap (where available)
- •b. Oral contraceptives (the pill”) for at least 1 month
- •c. Depot or injectable birth control or implantable contraception (e.g., Implanon)
- •d. Intrauterine device (IUD)
- •e. Documented evidence of surgical sterilization at least 6 months prior to Screening visit i.e., tubal ligation or hysterectomy for women or vasectomy for men
- •f. Women who are post-menopausal, as documented by measurement of follicle stimulating hormone (FSH)
排除标准
- •1. Presence of any of the following laboratory abnormalities at the Screening visit: a. White blood cell (WBC) below the lower limit of normal (LLN)
- •b. Neutrophil count below the LLN
- •c. Aspartate aminotransferase (AST) > 1.5 x the upper limit of normal (ULN)
- •d. Alanine aminotransferase (ALT) > 1.5 x the ULN
- •e. Creatine phosphokinase CPK >2ULN
- •f. Serum creatinine >1.2 ULN
- •2. Treatment with the following topical agents within 2 weeks before the Baseline visit: corticosteroids, phosphodiesterase inhibitors, tacrolimus or pimecrolimus
- •3. Systemic treatment for AD or for condition, with steroids or other immunosuppressive/ immunomodulating substances, e.g., cyclosporine, mycophenolate-mofetil, azathioprine or methotrexate within 4 weeks before the Baseline visit. Use of steroid inhalers and nasal corticosteroids is allowed.
- •4. Treatment with any cell depleting agents, e.g., rituximab, within 6 months of the Baseline visit or treatment with other biologics within 12 weeks of the Baseline visit
- •5. Prior treatment with dupilumab or any antibody against IL-4Ra or IL-13
- •6. Use of phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), tanning beds or any other light emitting device (LED), within 4 weeks before the Baseline visit
- •7. Two or more bleach baths within the 2 weeks before the Baseline visit
- •8. Treatment of AD with a prescription emollient (e.g., Atopiclair®, MimyX®, Epicerum®, etc.) within 2 weeks before the Baseline visit
- •9. Treatment with an investigational drug within 30 days or within 5 half-lives, whichever is longer, before the Baseline visit
- •10. Infection requiring treatment with oral or parenteral antibiotics, antivirals or systemic antifungals within 8 weeks before the Baseline visit
- •11. Superficial skin infections such as impetigo within 2 weeks before the Baseline visit
- •12. History of parasitic infection (e.g., helminth), within 6 months of the Baseline visit
- •13. History of vernal conjunctivitis
- •14. Known history of human immunodeficiency virus (HIV) infection
- •15. Positive results at the Screening visit for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody
- •16. Patients with positive QuantiFERON Gold test for tubercle bacillus (TB) at Screening
- •17. Treatment with a live (attenuated) vaccine within 8 weeks before the Baseline visit
- •18. History of malignancy within 5 years before the Baseline visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed
- •19. Patients with a known allergy to L-histidine, Trehalose or Tween (polysorbate) 80
- •20. Planned surgical procedure during participation in this study
- •21. Use of a tanning booth/parlour within 4 weeks of Baseline
- •22. Women who are pregnant, planning to become pregnant or breast-feeding women
- •23. Any medical or psychiatric condition, laboratory or ECG parameter which, in the opinion of the Investigator or the Sponsor’s Medical Monitor, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.
研究者
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