- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03644069
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
March 15, 2019 updated by: ImmusanT, Inc.
A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening.
This study will evaluate efficacy of Nexvax2 administered subcutaneously.
The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Auchenflower, Queensland, Australia, 4066
- The Wesley Hospital - The Wesley Research Institute
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Mackay, Queensland, Australia, 4740
- Coral Sea Clinical Research Institute
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Sippy Downs, Queensland, Australia, 4556
- Clinical Trials Centre - University of the Sunshine Coast
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Woolloongabba, Queensland, Australia, 4102
- The University of Queensland - Princess Alexandra Hospital
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Southern Australia
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Adelaide, Southern Australia, Australia, 5000
- Royal Adelaide Hospital
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Victoria
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Box Hill, Victoria, Australia, 3128
- Eastern Health-Box Hill Hospital
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Parkville, Victoria, Australia, 3052
- The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Auckland, New Zealand, 1010
- Auckland Clinical Studies
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Christchurch, New Zealand, 8011
- Gastroenterology and Endoscopy Specialists
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Havelock North, New Zealand
- P3 Research Limited
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Mount Cook, New Zealand, 6021
- P3 Research Limited
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California
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research
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Connecticut
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Stamford, Connecticut, United States, 06905
- Stamford Therapeutics Consortium
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Florida
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Lighthouse Point, Florida, United States, 33064
- Alliance Medical Research
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Grand Teton Research Group
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Illinois
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Chicago, Illinois, United States, 60637
- UCMC - Center for Clinical Cancer Genetics and Global Health
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Iowa
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Ames, Iowa, United States, 50010
- PMG Research of McFarland Clinic
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Kansas
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Wichita, Kansas, United States, 67207
- Heartland Research Associates
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Michigan
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Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan
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Troy, Michigan, United States, 48098
- Center for Digestive Health
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Wyoming, Michigan, United States, 49519
- West Michigan Clinical Research Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Nevada
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Las Vegas, Nevada, United States, 89119
- AB Clinical Trials
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- ActivMed Practices & Research
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New York
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Great Neck, New York, United States, 11023
- Long Island Gastrointestinal Research Group
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Hartsdale, New York, United States, 10530
- Drug Trials America
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New York, New York, United States, 10032
- Celiac Disease Center at Columbia University
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North Carolina
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Statesville, North Carolina, United States, 28625
- PMG Research of Piedmont Healthcare
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Winston-Salem, North Carolina, United States, 27103
- PMG Research of Winston-Salem, LLC
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Ohio
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Mentor, Ohio, United States, 44060
- Great Lakes Gastroenterology Research
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospitals - Center City Campus
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- Ocean State Clinical Research Partners
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Warwick, Rhode Island, United States, 02886
- Omega Medical Research
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research
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Tennessee
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Hermitage, Tennessee, United States, 37076
- Digestive Health Research
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Texas
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Southlake, Texas, United States, 76092
- Texas Digestive Disease Consultants
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Utah
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South Ogden, Utah, United States, 84405
- Advanced Research Institute
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Wisconsin
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Wauwatosa, Wisconsin, United States, 53226
- Allegiance Research Specialists
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo SQ injections: 32 in total, at twice weekly intervals
|
Experimental: Nexvax2
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Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
Time Frame: 79 to 93 days after baseline
|
Measured by the CeD Patient Reported Outcome (CeD PRO) between baseline and day of the first masked food challenge (MFC) containing gluten.
The CeD PRO captures patient ratings for a number of CeD-associated symptoms, on a 0 to 10 scale, with 0 being absent or no symptoms, and 10 being the most severe symptoms.
The Total GI domain score is calculated as an average of summed average and individual symptom scores relevant to the GI tract, to yield a value of 0 to 10.
|
79 to 93 days after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.
Time Frame: 79 to 93 days after baseline
|
Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten.
|
79 to 93 days after baseline
|
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
Time Frame: 79 to 93 days after baseline
|
Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten.
|
79 to 93 days after baseline
|
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
Time Frame: 79 to 93 days after baseline
|
Differences in each of the individual GI item scores in the CeD PRO between baseline and day of the first MFC containing gluten.
GI symptoms assessed on the CeD PRO include abdominal cramping, abdominal pain, bloating, diarrhea, gas, loose stool, and nausea.
Each are rated on a 0 to 10 scale, where 0 is absent and 10 is the most severe.
|
79 to 93 days after baseline
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Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.
Time Frame: Study Duration: 21 weeks
|
Treatment emergent adverse events (TEAEs) will be summarized by treatment arm, severity, relationship to study drug and to known or potential gluten exposure, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.
|
Study Duration: 21 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Robert Anderson, PhD, FRACP, ImmusanT, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
August 21, 2018
First Posted (Actual)
August 23, 2018
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 15, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nexvax2-2006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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