Celiac Disease Clinical Trial
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
Verified date | December 20, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA 2.1.1.1 Patients must be greater than or equal to 18-years-old. 2.1.1.2 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. 2.1.1.3 Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months 2.1.1.4 Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology 2.1.1.5 Patients must have a life expectancy of > 3 months 2.1.1.6 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) 2.1.1.7 Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN) 2.1.1.8 Patients must have a total bilirubin of less than 2.5 x ULN 2.1.1.9 Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration 2.1.1.10 Patients receiving a stable dose (> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible 2.1.1.11 Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study 2.1.1.12 Patients must be able to understand and sign an informed consent EXCLUSION CRITERIA 2.1.2.1 Patients enrolled in another therapeutic study 2.1.2.2 Patients with a history of venous thrombosis 2.1.2.3 Patients with antibodies to Hu-Mik-Beta-1 2.1.2.4 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. 2.1.2.5 Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection 2.1.2.6 History of malignancy (active or within the previous 5 years) 2.1.2.7 Patients with HIV infection (antibody positive) with positive confirmatory molecular tests 2.1.2.8 Patients who have chronic hepatitis B or chronic hepatitis C 2.1.2.9 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. 2.1.2.10 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. 2.1.2.11 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 2.1.2.12 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up 2.1.2.13 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) 2.1.2.14 Inability to give informed consent 2.1.2.15 History of diverticulitis |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic, Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | Mayo Clinic |
United States,
Cellier C, Delabesse E, Helmer C, Patey N, Matuchansky C, Jabri B, Macintyre E, Cerf-Bensussan N, Brousse N. Refractory sprue, coeliac disease, and enteropathy-associated T-cell lymphoma. French Coeliac Disease Study Group. Lancet. 2000 Jul 15;356(9225):203-8. — View Citation
Ryan BM, Kelleher D. Refractory celiac disease. Gastroenterology. 2000 Jul;119(1):243-51. Review. — View Citation
Trier JS. Celiac sprue. N Engl J Med. 1991 Dec 12;325(24):1709-19. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of Hu MIK Beta 1 in celiac disease pts | 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. | end of week 9 |
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