CTRI/2023/08/057118招募中3 期
A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active-Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg with EU-Approved Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients with Chronic Idiopathic Urticaria (CIU) who Remained Symptomatic Despite Treatment with Approved Doses of H1 Antihistamines - NI
Dr Prayag shah0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1.Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.
- •2.Male or female patients 18 to 60 years of age (both inclusive) at the time of screening.
- •3.Diagnosis of CIU refractory to H1 antihistamines at the time of randomization, as defined by all of the following:
- •?CIU diagnosis for at least 6 months.
- •?Must have been on an approved H1 antihistamine for CIU for at least 3 consecutive days immediately prior to the Day -14 screening visit and must document current use on the day of initial screening.
- •?Presence of itch and hives for = 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment.
- •?In-clinic UAS = 4 on at least 1 of the screening visit days (Day -14, Day -7, or Day 1).
- •?UAS7 (range 0-42) = 16 and itch component of UAS7 (range 0-21) = 8 during 7 days prior to randomization.
- •4.Willing and able to complete a daily symptom diary for the duration of the study and must not have any missing diary entries in the 7 days prior to randomization.
- •5.Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study and for 6 months thereafter.
- •6.Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone serum levels consistent with postmenopausal status.
排除标准
- •1.Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 30 days prior to initial dosing (90 days for biologics).
- •2.Clearly defined underlying etiology for chronic urticarias other than CIU.
- •3.Evidence of parasitic infection.
- •4.Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or any other skin disease associated with itch.
- •5.Previous treatment with omalizumab within a year prior to screening.
- •6.Routine doses of the following medications within 10 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide or investigational agents such as benralizumab or dupilumab etc.
- •7.IVIG, or plasmapheresis within 90 days prior to screening.
- •8.Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening.
- •9.Any H2 antihistamine use within 7 days prior to screening.
- •10.Any LTRA (such as montelukast or zafirlukast) within 10 to 14 days prior to screening.
- •11.Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
- •12.Hypersensitivity to omalizumab or any component of the formulation.
- •13.History of anaphylactic shock.
- •14.Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients.
- •15.Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
- •16.Evidence of current drug or alcohol abuse.
- •17.Positive test for hepatitis B, hepatitis C, or HIV.
- •18.Females with positive pregnancy tests at screening or any other visit.
- •19.Females who are breastfeeding or lactating.
- •20.History of any clinically significant disease or condition that, in the opinion of the Principal Investigator (PI)/designee, would render them unsuitable for inclusion in the study.
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