潰瘍性腸炎

AbGn-168H Neihulizumab

臨床試驗

治療藥物

AbGn-168H

疾病人口數

818,568人在美國有患有潰瘍性腸炎,34,216人醫療需求未被滿足[1]。
根據估計,在歐洲約250萬人有不當免疫反應造成的潰瘍性大腸炎[2],其中,70%~80%的潰瘍性大腸炎病人對於免疫抑制藥物5-氨基水楊酸(5-Amino Salicylic Acid)及類固醇等有好的反應,其餘中度及嚴重的病人,即便使用經FDA核准上市的生技藥物,如:腫瘤壞死因子抑制劑(TNF-αinhibitor)或抑制白血球移動的組合蛋白抑制劑(α4β7 Integrin inhibitor)等治療後,仍有將近約60%的病人無法得到理想的療效,而潰瘍性大腸炎在病理上,主要是因為免疫細胞攻擊腸膜組織引起的,本公司的AbGn-168H抗體主要是調控免疫T細胞,去除慢性及過度反應的免疫T細胞,是治療潰瘍性大腸炎的潛在有效藥物之一。
試驗說明
概念性驗證試驗,證明AbGn-168H (Neihulizumab)確實可以有效治療對免疫調節藥物或皮質類固醇治療反應不佳或無法耐受之中度至重度潰瘍性結腸炎患者,並同時進行藥物安全性評估。
試驗醫學中心
Newport Beach, CA Stomach Doctor - Surinder Saini, MD
  • Newport Beach, California, United States, 92660
  • Adriana Giron
  • 626-392-7033
  • adrianagiron@macksresearch.com
Orange, CA Fomat Medical Research
  • Orange, California, United States, 92868
Hialeah, FL Wellness Clinical Research (WCR)
  • Hialeah, Florida, United States, 33016-2202
  • Vanessa Amarales
  • 786-483-7856
  • vanessa@wellnessclinicalresearch.com
Lake Wales, FL Wellness Clinical Research (WCR)
  • Lake Wales, Florida, United States, 33853
  • Luis Bueno
  • 863-213-6331
  • Luis.Bueno@wellnessclinicalresearch.com
Atlanta, GA Consultative Gastroenterology
  • Atlanta, Georgia, United States, 30308
  • Robin Clark
  • 404-839-5351
  • robinkalani@gmail.com
Chicago, IL Northwestern University Feinberg School of Medicine
  • Chicago, Illinois, United States, 60611
  • Rose Arrieta
  • 312-695-5878
  • rarrieta@northwestern.edu
Chicago, IL University of Chicago
  • Chicago, Illinois, United States, 60637
  • Audrone Meiliulyte
  • 773-834-8709
  • ameiliulyte@medicine.bsd.uchicago.edu
Rockville, MD Capitol Research
  • Rockville, Maryland, United States, 20850
  • Erin Klepeis
  • 240-426-7392
  • Erin.Klepeis@CapitolResearch.com
New York, NY Weill Cornell Medical College
  • New York, New York, United States, 10021
  • Fatiha Chabouni
  • 212-746-5109
  • fac2005@med.cornell.edu
Rochester, NY University of Rochester Medical Center
  • Rochester, New York, United States, 14642
  • Cindy Doane
  • 585-276-6019
  • Cynthia_Doane@URMC.Rochester.edu
Houston, TX Baylor College of Medicine
  • Houston, Texas, United States, 77030
  • Guillermina Cruz
  • 713-798-8220
  • gcruz@bcm.edu
Seattle, WA University of Washington Medical Center (UWMC)
  • Seattle, Washington, United States, 98195
  • Kali Ferrell
  • 206-685-9175
  • FerrellK@medicine.washington.edu
Vega Baja, PR Wellness Clinical Research (WCR)
  • Vega Baja, Puerto Rico, 00694
關於 潰瘍性腸炎
潰瘍性結腸炎是一種發炎性腸道疾病,會引發持續性的發炎以及乙狀結腸及直腸黏膜下層潰瘍。有合併腸道發炎及潰瘍的病人會有腹部疼痛、腹瀉及直腸出血等症狀。目前沒有能完全治癒潰瘍性結腸炎的藥物,其病徵能因藥物治療得到緩解,並又復發。手術雖能永久有效的結束腸道潰瘍、發炎的症狀,但僅適用於嚴重炎症和危及生命併發症發生時的病人,因為它通常需要切除整個結腸和直腸。
文獻引用
1. IQVIA U.S. market survey with data to 2016
2. Kappelman et al. Clin Gastroenterol Hepatol. 2007; 5:1424-9. Loftus et al. ACG 2014 Annual Scientific Meeting. October 2014; Loftus Gastroenterology. 2004; 126(6):1504–1517.
更多關於我們的臨床試驗訊息,請上ClinicalTrials.gov查詢