A Study Of The Safety, Effectiveness And Tolerability Of Nexvax-2 In Patients With Celiac Disease (CeD)
Overview
Tab Title Description
Study type
InterventionalDescribes 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 IDs
Site IRB
- Rochester, Minnesota: 18-004575
Sponsor Protocol Number: Nexvax2-2006
About this study
The purpose of this study is to evaluate the human leukocyte antigen (HLA)-DQ 2.5+ in adults with celiac disease (CeD).
Participation eligibility
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults 18 to 70 years of age (inclusive).
- History of medically diagnosed celiac disease (CeD) that included duodenal biopsy.
- Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
- Willingness to consume a moderate amount of gluten.
- Able to read and understand English.
- Worsening of GI symptoms in response to an oral gluten challenge.
- HLA DQ 2.5 positive.
Exclusion Criteria:
- Unwilling or unable to perform self-injections.
- History of inflammatory bowel disease and/or microscopic colitis.
- Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
- Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening.
- Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
- Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
- Females who are lactating or pregnant.
- Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joseph Murray, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available