Antibody Treatment for Advanced Celiac Disease
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|ClinicalTrials.gov Identifier: NCT01893775|
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : January 18, 2020
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- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 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|
|Actual Primary Completion Date :||December 20, 2019|
|Actual Study Completion Date :||December 20, 2019|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA
126.96.36.199 Patients must be greater than or equal to 18-years-old.
188.8.131.52 All patients must have a pathologically confirmed diagnosis of refractory celiac disease(RCD) defined by internationally accepted criteria of persistent and recurrent symptoms(diarrhea, weight loss, and abdominal pain) associated with intestinal damage, characterized by partial to total villous atrophy with intraepithelial lymphocytes defined by > 25 intraepithelial lymphocytes per 100 epithelial cells.
184.108.40.206 Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months
220.127.116.11 Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology
18.104.22.168 Patients must have a life expectancy of > 3 months
22.214.171.124 Patients must have a creatinine of less than 2.0 mg/dL or if the patient has an elevated creatinine measured creatinine clearance (Ccr) must be > 60 mL/min/1.73m(2)
126.96.36.199 Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN)
188.8.131.52 Patients must have a total bilirubin of less than 2.5 x ULN
184.108.40.206 Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration
220.127.116.11 Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible
18.104.22.168 Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study
22.214.171.124 Patients must be able to understand and sign an informed consent
126.96.36.199 Patients enrolled in another therapeutic study
188.8.131.52 Patients with a history of venous thrombosis
184.108.40.206 Patients with antibodies to Hu-Mik-Beta-1
220.127.116.11 A contraindication to monoclonal antibody therapy including adverse events related to prior monoclonal antibody therapy. Patients who have received prior antibody therapy will have permanent medical records reviewed by the study investigator.
18.104.22.168 Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection
22.214.171.124 History of malignancy (active or within the previous 5 years)
126.96.36.199 Patients with HIV infection (antibody positive) with positive confirmatory molecular tests
188.8.131.52 Patients who have chronic hepatitis B or chronic hepatitis C
184.108.40.206 Pregnant or breastfeeding women. Women who not using an acceptable method of contraception. Acceptability of various methods of contraception will be determined by the investigator. Postmenopausal or surgically sterile women who have documentation of postmenopausal status or surgical sterility availability prior to enrollment.
220.127.116.11 Patients with significant co-morbidities including uncontrolled hypertension (diastolic B/P > 115 mm/Hg), unstable angina, congestive heart failure (> N.Y.H.A. Class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months or uncontrolled atrial or ventricular cardiac arrhythmias.
18.104.22.168 Abnormal screening/baseline tests exceeding the limits outlined below:
- Total white blood cell count (WBC) <300/mm(3)
- Platelet count <85,000/mm(3)
- INR greater than or equal to 1.5
- Serum creatinine level > 1.5 mg/dL
- Serum alanine transaminase, aspartate transaminase or creatinine kinase > 2 x the upper limits of normal
22.214.171.124 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up
126.96.36.199 Exclusion at the discretion of the PI or delegate if participation in the study is deemed too risky (e.g., clinically significant pleural or pericardial effusion or ascites)
188.8.131.52 Inability to give informed consent
184.108.40.206 History of diverticulitis
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
|United States, Minnesota|
|Mayo Clinic, Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas A Waldmann, M.D.||National Cancer Institute (NCI)|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||July 9, 2013 Key Record Dates|
|Last Update Posted:||January 18, 2020|
|Last Verified:||December 20, 2019|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Anti CD 122
Monoclonal Antibody Therapy
Autoimmune Inflammatory Enteropathy
Digestive System Diseases