Antibody Treatment for Advanced Celiac Disease

Completed · Phase 1

Conditions studied: Celiac Disease, Celiac Sprue, Gluten Enteropathy, Gluten-Sensitive Enteropathy

In brief

Background: \- 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. Objectives: \- To see if antibody therapy is a safe and effective treatment for celiac disease that has not responded to standard treatments. Eligibility: \- 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. Design: * 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.

Key facts

Study ID

NCT01893775

Run by

National Cancer Institute (NCI)

People needed

5

Starts

2013-06-12

Expected to finish

2019-12-20

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 1.2.1 Patients enrolled in another therapeutic study
• 1.2.2 Patients with a history of venous thrombosis
• 1.2.3 Patients with antibodies to Hu-Mik-Beta-1
• 1.2.4 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.
• 1.2.5 Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection
• 1.2.6 History of malignancy (active or within the previous 5 years)
• 1.2.7 Patients with HIV infection (antibody positive) with positive confirmatory molecular tests
• 1.2.8 Patients who have chronic hepatitis B or chronic hepatitis C
• 1.2.9 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.
• 1.2.10 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.
• 1.2.11 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
• 1.2.12 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up
• 1.2.13 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)
• 1.2.14 Inability to give informed consent
• 1.2.15 History of diverticulitis

Where it is running

• Mayo Clinic, Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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