Trial record 12 of 85 for:    (celiac disease) [CONDITION]

Phase I Study of Humanized Mik-Beta-1 Monoclonal Antibody (Hu-Mik-Beta-1)

This study is currently recruiting participants.
Verified September 2013 by Mayo Clinic
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Joseph A. Murray, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01893775
First received: May 23, 2013
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the administration of a monoclonal antibody (HU-Mik-β1) for the treatment of Refractory Celiac Disease. Currently there are no established or effective treatments for RCD beyond supportive measures and immune suppressive-like steroids. The drug targets the effects of a signal (IL-15) in the body that is believed to cause much of the damage in the intestine from refractory celiac disease. It is hoped that this drug will lessen the damage in your intestine and/or lessen the severity of the RCD.

HU-Mik-β1 is experimental and isn't approved by the U.S. Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug in this research study.


Condition Intervention Phase
Celiac Disease
Drug: Hu-Mik-Beta-1
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of subjects at 0.5 mg/kg dose experiencing greater than or equal to Grade 3 CTC AE toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects at 1.0 mg/kg dose experiencing greater than or equal to Grade 3 CTC AE toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects at 1.5 mg/kg dose experiencing greater than or equal to Grade 3 CTC AE toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hu Mik Beta 1
Escalating doses of Hu-Mik-Beta 1 starting at 0.5 Mg/KG body weight
Drug: Hu-Mik-Beta-1
Hu-Mik-Beta-1 will be administered intravenously at 0.5 mg/kg body weight to 3 patients on 3 occasions separated by 3 weeks. At the completion of Week 9, the safety data will be reviewed by sponsor and DSMB. If acceptable, an additional 3 patients will be administered Hu-Mik-Beta-1 intravenously at 1.0 mg/kg body weight on 3 occasions separated by 3 weeks. At the completion of Week 9, the safety data will be reviewed by sponsor and DSMB. If acceptable, an additional 3 patients will be administered Hu-Mik-Beta-1 intravenously at 1.5 mg/kg body weight on 3 occasions separated by 3 weeks.
Other Name: Hu-Mik-Beta-1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Persistence of diarrhea, weight loss, abdominal pain symptoms despite strict adherence to a gluten-free diet for 6-12 months
  • Must have circulating antibodies to transglutaminase-1
  • Live expectancy of more than 3 months
  • 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/1.73m2
  • Serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN)
  • 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 = 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

Exclusion Criteria:

  • 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
  • regnant 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.
  • Total white blood cell count (WBC) <300/mm3
  • Platelet count <85,000/mm3
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893775

Contacts
Contact: Carol T Van Dyke 507-266-7842 vandyke.carol@mayo.edu
Contact: Deanna L. Brogan 507-538-1206 brogan.deanna@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carol T. Van Dyke    507-266-7842    vandyke.carol@mayo.edu   
Contact: Deanna L. Brogan    507-538-1206    brogan.deanna@mayo.edu   
Principal Investigator: Joseph A. Murray, MD         
Sub-Investigator: Vandana Nehra, MD         
Sponsors and Collaborators
Joseph A. Murray, M.D.
University of Chicago
Investigators
Principal Investigator: Joseph Murray, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Joseph A. Murray, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01893775     History of Changes
Other Study ID Numbers: 12-008200
Study First Received: May 23, 2013
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
celiac disease
gluten
gluten sensitive enteropathy
refractory

Additional relevant MeSH terms:
Celiac Disease
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Malabsorption Syndromes
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014