Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×

  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.



  • Celiac.com Sponsor (A1):

    Celiac.com Sponsor (A1-M):

  • Get Celiac.com Updates:
    Support Our Content
    eNewsletter
    Donate

  • Record is Archived

    This article is now archived and is closed to further replies.

    Jefferson Adams
    Jefferson Adams

    By Jefferson Adams •

    Mayo Team Reviews Endpoints for Phase 2 and 3 Trials on New Celiac Drugs

    Reviewed and edited by a celiac disease expert.

    Celiac.com 04/18/2015 - Research is underway on a number of new drugs intended to celiac disease treatment beyond a simple gluten-free diet. However, even though several drugs are in Phase 2 trials and results appear promising, discussion around regulatory endpoints is just beginning.

    Photo: CC--TrippA research team recently reviewed endpoints for Phase 2 and 3 trials of new celiac disease drugs currently under development, and detailed their results in a scientific paper. The team included Klaus Gottlieb, Jill Dawson, Fez Hussain and Joseph A. Murray. They are variously affiliated with the department of Immunology and Internal Medicine of Medical Strategy & Science, Quintiles, Durham, NC, USA, with Corporate Communications, Quintiles, Durham, NC, USA, and with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

    Celiac.com Sponsor (A12):
    In the paper, the team discusses celiac drugs currently under development, along with trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests.

    They outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. They conclude their paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review.

    Stay tuned for more news and information on all developments concerning trials of new celiac drug treatments.

    Source:

    • Open Original Shared Link

     Share
    Go to articles

    User Feedback

    Recommended Comments

    There are no comments to display.



    Guest
    This is now closed for further comments

  • Get Celiac.com Updates:
    Support Celiac.com:
    Join eNewsletter
    Donate

  • About Me

    Jefferson Adams

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     

  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):



    Celiac.com Sponsors (A17-M):



  • Related Articles

    Jefferson Adams
    Celiac Disease Rates in Iran Similar to Europe
    Celiac.com 04/08/2011 - A medical research team recently conducted an epidemiological review of celiac disease in Iran. The team included M. Rostami Nejad, K. Rostami, M. H. Emami, M. R. Zali, and R. Malekzadeh.
    They are associated variously with the Research Institute for Gastroenterology and Liver Diseases at Shahid Beheshti University of Medical Science, with the Digestive Disease Research Center,Tehran University of Medical Sciences, both in Tehran, Iran, with the Poursina Hakim Research Institute (PHRI), Isfahan University of MedicalSciences (IUMS), Isfahan, Iran, and with the School of Medicine, University of Birmingham, United Kingdom.
    Celiac disease has been traditionally believed to be a chronic  enteropathy, almost exclusively affecting people of European  origin. The u...
    Jefferson Adams
    Alvine Pharmaceuticals: ALV003 Shows Promise in Celiac Disease Patients
    Celiac.com 11/14/2011 - Alvine Pharmaceuticals claims that Phase 2a clinical trial of ALV003 demonstrates the drug's ability to mitigate gluten-triggered intestinal mucosal damage in serologically negative celiac disease patients who followed a gluten-free diet for one or more years.
    The company presented findings from the study at the 19th United European Gastroenterology Week (UEGW) in Stockholm. Alvine will present their data in an abstract, titled "ALV003, a Novel Glutenase, Attenuates Gluten-Induced Small Intestinal Mucosal Injury in Celiac Disease Patients: A Randomized Controlled Phase 2A Clinical Trial,"
    The results are important because "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal...
    Jefferson Adams
    Are Celiac Disease Rates in China Higher Than Reported?
    Celiac.com 12/25/2013 - At present, the number of reported celiac disease cases is extremely low in China. 
    Until recently, celiac disease was considered to be rare in China. A team of researchers recently set out to compile an accurate estimate of rates of celiac disease in China.
    The research team included Juanli Yuan, Jinyan Gao, Xin Li, Fahui Liu, Cisca Wijmenga, Hongbing Chen, and Luud J. W. J. Gilissen. They are variously affiliated with the State Key Laboratory of Food Science and Technology, the College of Pharmaceutical Sciences, and the School of Life Sciences and Food Engineering, at Nanchang University in Nanchang, China, the Department of Genetics at the University Medical Centre Groningen ofUniversity of Groningen in Groningen, The Netherlands, with the Sino-German ...
    Jefferson Adams
    Celiac Disease Rates in China May be Higher than Reported
    Celiac.com 09/01/2014 - At present, the number of reported celiac disease cases in China is extremely low, and celiac disease is considered to be rare in that country. To determine the accuracy of this perspective, a team of researchers recently set out to compile an accurate estimate of rates of celiac disease in China.
    The research team included Juanli Yuan, Jinyan Gao, Xin Li, Fahui Liu, Cisca Wijmenga, Hongbing Chen, and Luud J. W. J. Gilissen. They are variously affiliated with the State Key Laboratory of Food Science and Technology, the College of Pharmaceutical Sciences, and the School of Life Sciences and Food Engineering, at Nanchang University in Nanchang, China, the Department of Genetics at the University Medical Centre Groningen of University of Groningen in Groningen...

  • Recent Activity

    1. Savannah Wert
      - Savannah Wert replied to Savannah Wert's topic in Coping with Celiac Disease
      2

      Hey all!

      Thank you! I’m currently the breadwinner as my husband is pursuing a finance degree so the nights that I am at work they can eat whatever my husband makes but when I am home we have gluten free meals and no complaints so far! I definitely don’t have a choice but to switch but I think slowly transitioning my family is good!😀
    2. trents
      - trents replied to Savannah Wert's topic in Coping with Celiac Disease
      2

      Hey all!

      Welcome aboard, @Savannah Wert! There usually is a learning curve involved in arriving at a consistently gluten free diet since gluten is found in so many food products where you would never expect it to be. This article may be helpful: It is good that you have identified some other foods that you cannot tolerate at this point as this is so common...
    3. Savannah Wert
      - Savannah Wert posted a topic in Coping with Celiac Disease
      2

      Hey all!

      Hey everyone! I just joined and figured I’d introduce myself, my name is Savannah, I’ve been with my husband for over 8 years and we have 3 kids, a 7 year old, 5 year old, and 3 year old. I was diagnosed with celiac disease beginning of October along with microscopic colitis, lactose intolerance, and sucrose intolerance. I got sick the day before my 5th ...
    4. glucel
      - glucel replied to Bindi's topic in Super Sensitive People
      36

      Refractory or super sensitive?

      I don't react the same way to all of them but do react badly to many of them where others may not. I also have a touch of hypochondria so when the labs come back too high or makes me anxious. I am dismayed but not really surprised that I may be in the small group of people to suffer a particular side effect. I was originally on warfirin. I think that was...
    5. trents
      - trents replied to Bindi's topic in Super Sensitive People
      36

      Refractory or super sensitive?

      What do you mean when you say, "blood thinners are all the same to me"? Do you mean you react negatively in the same way to all of them? Otherwise, they are not all the same. They work in different ways. Aspirin causes the platelets to be less sticky. Warfarin and related meds work by reducing the production of platelets. You might talk to your doctor about...
  • Celiac.com Sponsor (A19):


  • Member Statistics

    • Total Members
      125,942
    • Most Online (within 30 mins)
      7,748
    sheridreghornn
    Newest Member
    sheridreghornn
    Joined
  • Celiac.com Sponsor (A20):

  • Forum Statistics

    • Total Topics
      120.9k
    • Total Posts
      69k
  • Celiac.com Sponsor (A22):



  • Who's Online (See full list)

    • There are no registered users currently online
  • Celiac.com Sponsor (A21):


  • Popular Now

    • Dawn R.
      4
      Gluten Ataxia

      By Dawn R.
      Started

    • jadeceoliacuk
      5
      How to choose a Naturopath for 6yr old

      By jadeceoliacuk
      Started

    • Gluten is bad
      7
      Gluten Free ADHD medications

      By Gluten is bad
      Started

    • pasqualeb
      13
      Muscle atrophy in legs

      By pasqualeb
      Started

    • Bindi
      36
      Refractory or super sensitive?

      By Bindi
      Started

  • Popular Articles

    • Scott Adams
      60
      The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free

      By Scott Adams

    • Scott Adams
      78
      Forbidden Gluten Food List (Unsafe Ingredients)

      By Scott Adams

    • Scott Adams
      66
      Safe Gluten-Free Food List (Safe Ingredients)

      By Scott Adams

    • Scott Adams
      144
      What Are the Symptoms of Celiac Disease?

      By Scott Adams

    • Scott Adams
      72
      Gluten-Free Alcoholic Beverages

      By Scott Adams

  • Upcoming Events

×
×
  • Create New...