A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Autoimmune Diseases 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03644069
• Other study ID #: Nexvax2-2006
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 6, 2018
• Est. completion date: September 2019

Study information

• Verified date: March 2019
• Source: ImmusanT, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Celiac
• Celiac Disease
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gluten Sensitivity
• Intestinal Disease
• Intestinal Diseases
• Malabsorption Syndromes

Intervention

Biological:
• Nexvax2
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
• Placebo
Placebo SQ injections: 32 in total, at twice weekly intervals

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ImmusanT, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

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

External Links

•   ImmusanT