EUCTR2011-004216-31-DE进行中（未招募）不适用
A phase II, multi-centre, randomized, double blind, placebo-controlled study to determine the mode of action of omalizumab in patients with chronic idiopathic urticaria (CIU) who remain symptomatic with antihistamine treatment (H1)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline (Day -14), as defined by all of the following:
- •The presence of itch and hives for > 6 weeks prior to Baseline (Day –14),
- •UAS7 score (range 0-42) = 16 and itch component of UAS7 (range 0-21) = 8 during 14 days prior to randomization (pre-dose Day 1). To avoid influences of antihistamines on the outcome of the UAS7, the score will be calculated as follows:
- •Patients must have been on an approved dose of an H1 antihistamine for CIU prior to entering the study, and agree to a washout of 3 consecutive days prior to Day -14 which is required in order for the Day -14 Baseline visit to be performed. Patients must agree to switching their current H1 antihistamine to Loratadine, 10 mg, at Baseline (Day -14) that will be used as their rescue medication during the study,
- •CIU diagnosis for = 6 months.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •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.
- •Previous treatment with omalizumab.
- •A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.
- •Routine doses of the following medications:
- •Systemic or cutaneous (topical) corticosteroids (prescription or over the counter),
- •hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide or any other
- •immunomodulating drug (e.g. interferons) that may alter the response to omalizumab
- •treatment 30 days prior to Day -14,
- •IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14,
- •Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day -14,
- •Any H2 antihistamine use within 7 days prior to Day -14,
- •Any leukotriene receptor antagonists (LTRA) (montelukast or zafirlukast) or H2 blockers within 7 days prior to Day -14,
- •Any H1 antihistamines at greater than approved doses within 3 days prior to Day -14,
- •Patients taking either LTRAs or H2 blockers for diseases other than CIU (e.g., asthma or GERD, respectively) will be permitted to continue their use during the study. Inhaled asthma controllers, including corticosteroids, are also permitted during the study. Patients need to on stable doses for 4 weeks prior to randomization (Day 1).
- •History of anaphylactic shock.
研究者
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