EUCTR2021-000149-42-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Parallel group, Active Controlled Study to Compare the Efficacy and Safety of SYN008 to Xolair® in Adult Patients with Chronic Spontaneous Urticaria and Inadequate Response to H1 Antihistamine Treatment
Synermore Biologics Co., Ltd0 个研究点目标入组 480 人开始时间: 2021年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
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
- •Patients must meet all of the following criteria to be included in the study:
- •1. Have read, understood, and signed the informed consent form (ICF) before any protocol-specific procedure including screening procedures.
- •2. Male or female aged = 18 years with a clinical diagnosis of CSU for at least 6 months prior to first administration of study drug.
- •3. Have a diagnosis with CSU refractory to H1 antihistamines defined as:
- •a. Presence of hives associated with itch for > 6 consecutive weeks at any time prior to screening despite concomitant H1 antihistamines treatment.
- •b. UAS7 = 16 and ISS7 = 8 during the 7 days (without any missing day in the completion of the symptom e-diary) prior to first administration of study drug.
- •c. Use of H1 antihistamines at a stable dose up to 4-fold the approved dose for = 3 consecutive days immediately prior to Screening Visit and throughout the study (list of permitted antihistamines in APPENDIX 2).
- •4. Must be willing to continue H1 antihistamines at stable dose throughout the study.
- •5. Must be willing and able to complete a symptom diary twice daily for 7 days prior to first administration of study drug and throughout the study.
- •6. Females of childbearing potential (FOCBP) and male patients with a female partner of childbearing potential must be willing to take reliable contraceptive precautions throughout the study (until Week 32).
- •If an FOCBP, patient should have a negative pregnancy test result at Screening and Baseline visits
- •Must be willing to comply with precautions to reduce the risk of COVID-19 infection in accordance with recommendations from the applicable medical associations and the investigator for the duration of the study and to undergo COVID-19 polymerase chain reaction (PCR) test as required based on the investigator judgment and/or local requirements.
- •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 480
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
- •1. Known hypersensitivity to omalizumab, study treatment excipients, or components of injecting devices.
- •2. Previous exposure to omalizumab (either Xolair or a biosimilar product).
- •3. Previous exposure to ligelizumab or any IgE antagonists.
- •4. Having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria.
- •5. Conditions that may have urticarial or angioedema symptoms (eg, urticaria pigmentosa, urticarial vasculitis, hereditary or acquired angioedema, erythema multiforme, mastocytosis, lymphoma).
- •6. Has the evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. Stool testing will be conducted only in patients presenting at screening with a risk factor for parasitic infection (living in endemic region, chronic gastrointestinal symptoms, and/or chronic immunosuppression) and an eosinophil count > 2 × upper limit of normal (ULN).
- •7. Positive serology results of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody) at screening.
- •8. Any other skin disease associated with chronic itching that might influence in the investigator’s opinion the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus).
- •9. Any current active infection requiring treatment.
- •10. Body temperature of 37.5 °C or above at screening or baseline visits, and/or signs or symptoms that in the opinion of the investigator may be suggestive of COVID-19 infection. The patient may be allowed to enter the study if a COVID-19 PCR test performed during the Screening Period results in a negative outcome or had received an approved COVID-19 vaccine (if available), based on investigator’s clinical judgment.
- •11. Has received H2 antihistamines and/ or LTRAs within 7 days prior to Screening Visit.
- •12. Routine doses (ie, daily or every other day for = 5 consecutive days) of systemic or cutaneous (topical) corticosteroids (prescription or over-the-counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide within 30 days prior to Screening Visit. 13. Intravenous immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Screening Visit.
- •14. Regular (daily/every other day) use of oral doxepin = 2 weeks prior to Screening Visit.
- •15. Treatment with an investigational agent = 30 days or = 5 × half-life, whichever is longer, prior to Screening Visit.
- •16. Has a current or history of malignancy, except non-melanoma skin cancer that has been treated or excised and is considered resolved.
- •17. History of anaphylactic reaction.
- •18. Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions including abnormal blood/urine test results that could, in the investigator’s opinion, interfere with the interpretation of the study results and or compromise the safety of the patients.
- •19. History of and/or concomitant immune complex disease (including Type III hypersensitivity), hyperimmunoglobulin E syndrome, autoimmune disease or bronchopulmonary aspergil
研究者
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