EUCTR2010-022784-35-DE进行中（未招募）不适用
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SAFETY STUDY OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDIOPATHIC URTICARIA (CIU) WHO REMAIN SYMPTOMATIC DESPITE TREATMENT WITH H1 ANTIHISTAMINES, H2 BLOCKERS, AND/OR LEUKOTRIENE RECEPTOR ANTAGONISTS - GLACIA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 321
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 the following criteria for study entry:
- •1. Aged 12-75 years (age limits may vary dependent upon regional restrictions)
- •2. Diagnosis of CIU refractory to H1 antihistamines, H2 blockers, and/or LTRAs
- •at the time of randomization, as defined by all of the following:
- •The presence of itch and hives for > 6 consecutive weeks at any time prior
- •to enrollment despite current use of H1 antihistamine (up to four times the
- •approved dosage), H2 blocker, and/or LTRA treatment during this time period
- •UAS7 score (range 0-42) = 16 and itch component of UAS7 (range 0-21)
- •= 8 during 7 days prior to randomization (Week 0)
- •In-clinic UAS = 4 on at least one of the screening visit days (Day -14,
- •Day -7, or Day 1)
- •Patients must have been on H1 antihistamine (up to four times the approved
- •dosage), H2 blocker, and/or LTRA for CIU for at least the 3 consecutive
- •days immediately prior to the Day -14 screening visit and must document
- •current use on the day of the initial screening visit.
- •CIU diagnosis for = 6 months
- •3. Willing to give written informed consent, adhere to the visit schedules and
- •meet study requirements
- •For those patients below the legal age of consent, the child must be willing
- •to give written informed assent and the parent(s)/guardian(s) must be
- •willing to give written informed consent.
- •For patients below the legal age of consent, both child and parent must be
- •able to adhere to dose and visit schedules and meet study requirements.
- •4. Willing and able to complete a daily symptom eDiary for the duration of the study
- •5. Patients must not have any missing eDiary entries in the 7 days prior
- •to randomization
- •Are the trial subjects under 18? yes
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •1. Treatment with an investigational agent within 30 days of Day -14
- •2. Weight less than 20 kg (44 lbs)
- •3. Clearly defined underlying etiology for chronic urticarias other than CIU
- •(main manifestation being physical urticaria). This includes the following urticarias:
- •Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact
- •As well as the following diseases as these diseases may have
- •symptoms of urticaria or angioedema
- •Urticarial vasculitis, urticaria pigmentosa, erythema multiforme,
- •mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia,
- •or generalized cancer
- •4. Evidence of parasitic infection defined as having the following three items:
- •Risk factors for parasitic disease (living in an endemic area,
- •chronic GI symptoms, travel within the last 6 months to an endemic area
- •and/or chronic immunosuppression)
- •An absolute eosinophil count more than twice the upper limit of normal
- •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 both risk factors and an eosinophil count more
- •than twice the upper limit of normal
- •5. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile
- •pruritus or other skin disease associated with itch
- •6. Previous treatment with omalizumab within a year prior to Day -14
- •7. Routine (daily or every other day during 5 or more consecutive days) doses of
- •the following medications within 30 days prior to Day -14: systemic or
- •cutaneous (topical) corticosteroids (prescription or over the counter),
- •hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
- •8. IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day –14
- •9. Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -14
- •10. 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
- •11. Hypersensitivity to omalizumab or any component of the formulation
- •12. History of anaphylactic shock
- •13. 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
- •14. Medical examination or laboratory findings that suggest the possibility of
- •decompensation of co-existing conditions for the duration of the study. Any items
- •that are cause for uncertainty must be reviewed with the Medical Monitor.
- •15. Inability to comply with study and follow-up procedures
- •16. Evidence of current drug or alcohol abuse
- •17. Nursing women and women of childbearing potential, defined as all women physiologically
- •capable of becoming pregnant, including women whose career, lifestyle,
- •or sexual orientation precludes intercourse with a male partner and women
- •whose partners have been sterilized by vasectomy or other means,
- •UNLESS they meet the following definition of post-menopausal: 12 months
- •of natural (spontaneous) amenorrhea or 6 months of spontaneous
- •amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks post-surgical
- •bilateral oophorectomy (with or without hysterectomy) or hysterectomy
- 另有 1 项未显示
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