EUCTR2021-001796-17-PL进行中（未招募）1 期
A Multinational, Multicenter, Randomized, Double Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV 45779 Compared to Omalizumab (XOLAIR®) in Patients With Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria who Remain Symptomatic Despite Antihistamine (H1) Treatment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •a. Male or female patients aged =18 years and =75 years.
- •b. Diagnosis of CIU/CSU refractory to H1 antihistamines at the time of randomization, as defined by all of the following:
- •-The presence of itch and wheals for =8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment during this time period.
- •-Weekly urticaria activity score (UAS7; sum of the daily number of wheals score and itch severity score over 7 days) =16 (range 0 42) and itch component of UAS7 =8 (range 0 21) during 7 days prior to randomization.
- •-Urticaria activity score (UAS) =4 assessed by a clinician on =1 of the screening visit days.
- •-Patients must have been on an approved dose of an H1 antihistamine for CIU/CSU for =3 consecutive days immediately prior to the start of screening and must document current use on the day of the initial screening visit, OR, have their H1 antihistamine for CIU/CSU adjusted to an approved dose during the first 3 days of screening and have their adjusted use documented at the end of the dose adjustment.
- •-CIU/CSU diagnosis for =3 months.
- •c. Women may be included if they fulfill one of the following criteria:
- •-Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1 year postmenopausal (no menses for 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] of more than 35 U/L) in women not using hormonal contraception or hormonal replacement therapy.
- •-Women of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must:
- •-have a negative beta human chorionic gonadotropin (ß HCG) test at baseline;result at screening (visit 2); and
- •-use highly effective birth control methods for the duration of the study (ie, starting at screening) and for 5 half lives (20 weeks) after last dose of IMP.
- •Highly effective birth control methods are methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered. Such methods include:
- •-Combined estrogen and progestogen hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation; these should be initiated at least 7 days before the first dose of IMP.
- •-Progestogen only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; these should be initiated at least 7 days before the first dose of IMP.
- •-Intrauterine device or intrauterine hormone releasing system need to be in place at least 2 months before the start of screening.
- •-Bilateral tubal occlusion (for hysteroscopic Essure®” a hysterosalpingogram is required 3 months post procedure to assess surgical success) or tubal ligation.
- •-Vasectomized partner provided he is the sole sexual partner and has received medical assessment of the surgical process success.
- •-Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
- •d. Male patients (including vasectomized men) with partners who are of childbearing potential (whether pregnant or not) must use condoms prior to IMP administration and until 20 weeks after last IMP dose.
- •e. Must be a
排除标准
- •a. Body weight <40 kg.
- •b. Clearly defined underlying etiology for chronic urticarias other than CIU/CSU.
- •c. Evidence of parasitic infection defined as meeting the following 3 criteria:
- •-Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression), and
- •-An absolute eosinophil count more >2× the upper limit of normal (ULN), and
- •-Evidence of parasitic colonization or infection on stool evaluation for ova and parasites. Note that stool ova and parasite evaluation will only be conducted in patients with risk factor(s) and an eosinophil count >2× the ULN.
- •d. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
- •e. Treatment with an investigational agent within 30 days or longer depending on half life (>5 half lives) prior to the start of screening.
- •f. Previous treatment with omalizumab or other Anti-IgE therapy within a year prior to the start of screening.
- •g. Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- •h. Intravenous immunoglobulin G, or plasmapheresis within 30 days prior to the start of screening.
- •i. Regular (daily/every other day) doxepin (oral) use within 2 weeks prior to the start of screening.
- •j. Any H2 antihistamine use within 7 days prior to the start of screening.
- •k. Any LTRA (montelukast or zafirlukast) use within 7 days prior to the start of screening.
- •l. Any H1 antihistamines at greater than approved doses use from 3 days after the start of screening.
- •m. Current malignancy, history of malignancy within 5 last years, or currently under work up for suspected malignancy except non melanoma skin cancer that has been treated or excised and is considered resolved.
- •n. Hypersensitivity to omalizumab or any component of the formulation.
- •o. History of anaphylactic shock.
- •p. Contraindications to diphenhydramine hydrochloride.
- •q. Pregnant or lactating woman, or plans to become pregnant during the study.
- •r. 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.
- •s. Evidence of current drug or alcohol abuse.
- •t. Patients taking either LTRAs or H2 blockers for diseases other than chronic idiopathic urticaria (CIU) (eg, asthma or gastroesophageal reflux disease, respectively) will be permitted to continue their use during the study. These diseases must be recorded as part of the medical history collected during the screening period. Inhaled asthma controllers, including corticosteroids, are also permitted during the study.
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