NL-OMON50623已完成2 期
A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 (0456/0113)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men and women 18 to 60 years of age at screening.
- •2. Clinical diagnosis of FOP (based on findings of congenital malformation of
- •the great toes, episodic soft tissue swelling, and/or progressive heterotopic
- •ossification).
- •3. Confirmation of FOP diagnosis with documentation of any ACVR1 mutation.
- •4. FOP disease activity within 1 year of screening visit. FOP disease activity
- •is defined as pain, swelling, stiffness, and other signs and symptoms
- •associated with FOP flare-ups; or worsening of joint function, or radiographic
- •progression of heterotopic ossifications (increase in site or number of HO
- •lesions) with/without being associated with flare-up episodes.
- •5. Willing and able to undergo PET and CT imaging procedures and other
- •procedures as defined in this study.
排除标准
- •1. Significant concomitant illness or history of significant illness such as,
- •but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric,
- •endocrine, metabolic or lymphatic disease, that in the opinion of the study
- •investigator might confound the results of the study or pose additional risk to
- •the patient by their participation in the study.
- •2. Use of bisphosphonate within 1 year of screening.
- •3. Concurrent participation in another interventional clinical study, or a
- •non-interventional study with radiographic measures or invasive procedures (eg
- •collection of blood or tissue samples). Participation in the FOP Connection
- •Registry or other studies in which patients complete study questionnaires are
- •4. Pregnant or breastfeeding women.
- •5. Male and women of childbearing potential patients who are unwilling to
- •practice highly effective contraception.
- •6. Patients who are on concomitant antiplatelet therapy (eg, clopidogrel),
- •anti-coagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin
- •inhibitors) in the last 30 days or within 5 half-lives of the therapy,
- •whichever is longer. Low dose (*100 mg/day) acetylsalicylic acid (aspirin) is
- •acceptable.
- •7. Patients with a history of severe, non-traumatic bleeding requiring
- •transfusion or hospitalization for hemodynamic compromise
- •8. Patients with a known pre-existing medical history of a bleeding diathesis
- •(eg, hemophilia A, von Willebrand*s Factor deficiency, platelet count *20x10^9/
研究者
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