MedTrace Logo

Antibody Treatment for Advanced Celiac Disease

NCT01893775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Celiac Disease
  • Celiac Sprue
  • Gluten Enteropathy
  • Gluten-Sensitive Enteropathy

Interventions

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)

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Thomas A Waldmann, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-12
Primary Completion
2019-12-20
Completion
2019-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01893775 on ClinicalTrials.gov