Antibody Treatment for Advanced Celiac Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01893775|
Recruitment Status : Recruiting
First Posted : July 9, 2013
Last Update Posted : September 5, 2018
- Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-free diet. However, some people have digestion problems even on a gluten-free diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may block the immune reaction that causes the disease. They will test this antibody in people who have celiac disease that has not responded to a gluten-free diet.
- To see if antibody therapy is a safe and effective treatment for celiac disease that has not responded to standard treatments.
- Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months but still have symptoms of celiac disease.
- Participants will be screened with a physical exam and medical history. Blood samples will be collected. These samples will help determine if the specific antibody treatment is likely to work.
- Before the start of the study, participants will have a biopsy of the small intestine.
- Participants will receive three doses of the study antibody as injections. These doses will be given 3 weeks apart.
- Treatment will be monitored with blood tests and heart function tests. Participants will also have a second small intestine biopsy within a week after the last dose of the antibody.
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease Celiac Sprue Gluten Enteropathy Gluten-Sensitive Enteropathy||Biological: Hu-Mik- Beta-1||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of the Humanized Mik-Beta-1 Monoclonal Antibody Directed Toward IL-2/IL-15R Beta (CD122) That Blocks IL-15 Action In Patients With Refractory Celiac Disease|
|Study Start Date :||June 12, 2013|
|Estimated Primary Completion Date :||June 3, 2020|
|Estimated Study Completion Date :||June 3, 2021|
Hu-Mik-Beta-1 every 3 weeks
Biological: Hu-Mik- Beta-1
Hu-Mik-Beta-1 every 3 weeks for a total of 3 doses (given on day 1, week 3 and week 6)
- safety of Hu MIK Beta 1 in celiac disease pts [ Time Frame: end of week 9 ]Events will be tabulated and reported by grade with evaluationalso of supportive medications and surrogate markers of absorptionsuch as body mass index, albumin and hemoglobin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893775
|Contact: Thomas A Waldmann, M.D.||(240) email@example.com|
|United States, Minnesota|
|Mayo Clinic, Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Carol Van Dyke 507-266-7842 firstname.lastname@example.org|
|Contact: Deanna Brogan (507) 538-1206 email@example.com|
|Principal Investigator:||Thomas A Waldmann, M.D.||National Cancer Institute (NCI)|