Antibody Treatment for Advanced Celiac Disease
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-008200
NCT ID: NCT01893775
Sponsor Protocol Number: 12-008200
About this study
- 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients must be greater than or equal to 18-years-old.
- 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.
- Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months
- Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology
- Patients must have a life expectancy of > 3 months
- 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)
- Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN)
- Patients must have a total bilirubin of less than 2.5 x ULN
- Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration
- Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible
- Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study
- Patients must be able to understand and sign an informed consent
- Patients enrolled in another therapeutic study
- Patients with a history of venous thrombosis
- Patients with antibodies to Hu-Mik-Beta-1
- 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.
- Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection
- History of malignancy (active or within the previous 5 years)
- Patients with HIV infection (antibody positive) with positive confirmatory molecular tests
- Patients who have chronic hepatitis B or chronic hepatitis C
- 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.
- 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.
- 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
- Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up
- 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)
- Inability to give informed consent
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.