Celiac Disease Clinical Trial
Official title:
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
Verified date | March 2019 |
Source | ImmusanT, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
Status | Active, not recruiting |
Enrollment | 146 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | Southern Australia |
Australia | The Wesley Hospital - The Wesley Research Institute | Auchenflower | Queensland |
Australia | Eastern Health-Box Hill Hospital | Box Hill | Victoria |
Australia | Coral Sea Clinical Research Institute | Mackay | Queensland |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research | Parkville | Victoria |
Australia | Clinical Trials Centre - University of the Sunshine Coast | Sippy Downs | Queensland |
Australia | The University of Queensland - Princess Alexandra Hospital | Woolloongabba | Queensland |
New Zealand | Auckland Clinical Studies | Auckland | |
New Zealand | Gastroenterology and Endoscopy Specialists | Christchurch | |
New Zealand | P3 Research Limited | Havelock North | |
New Zealand | P3 Research Limited | Mount Cook | |
United States | PMG Research of McFarland Clinic | Ames | Iowa |
United States | Clinical Research Institute of Michigan | Chesterfield | Michigan |
United States | UCMC - Center for Clinical Cancer Genetics and Global Health | Chicago | Illinois |
United States | Long Island Gastrointestinal Research Group | Great Neck | New York |
United States | Drug Trials America | Hartsdale | New York |
United States | Digestive Health Research | Hermitage | Tennessee |
United States | Grand Teton Research Group | Idaho Falls | Idaho |
United States | University of Iowa | Iowa City | Iowa |
United States | AB Clinical Trials | Las Vegas | Nevada |
United States | Alliance Medical Research | Lighthouse Point | Florida |
United States | Ocean State Clinical Research Partners | Lincoln | Rhode Island |
United States | Great Lakes Gastroenterology Research | Mentor | Ohio |
United States | Coastal Carolina Research | Mount Pleasant | South Carolina |
United States | Celiac Disease Center at Columbia University | New York | New York |
United States | Thomas Jefferson University Hospitals - Center City Campus | Philadelphia | Pennsylvania |
United States | ActivMed Practices & Research | Portsmouth | New Hampshire |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Advanced Research Institute | South Ogden | Utah |
United States | Texas Digestive Disease Consultants | Southlake | Texas |
United States | Stamford Therapeutics Consortium | Stamford | Connecticut |
United States | PMG Research of Piedmont Healthcare | Statesville | North Carolina |
United States | Center for Digestive Health | Troy | Michigan |
United States | Diablo Clinical Research | Walnut Creek | California |
United States | Omega Medical Research | Warwick | Rhode Island |
United States | Allegiance Research Specialists | Wauwatosa | Wisconsin |
United States | Heartland Research Associates | Wichita | Kansas |
United States | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina |
United States | West Michigan Clinical Research Center | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
ImmusanT, Inc. |
United States, Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. | 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 | Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten. | Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten. | 79 to 93 days after baseline | |
Secondary | Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains. | Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten. | 79 to 93 days after baseline | |
Secondary | Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms. | 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 | |
Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2. | 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 |
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