Clinical trial NCT03644069: A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Celiac Disease
Celiac
Intestinal Disease
Malabsorption Syndromes
Gastrointestinal Disease
Digestive System Disease
Gluten Sensitivity
Autoimmune Diseases
Lead sponsor: ImmusanT, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
timeFrame: 79 to 93 days after baseline
Secondary outcomes:
measure: Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.
timeFrame: 79 to 93 days after baseline
measure: Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
timeFrame: 79 to 93 days after baseline
measure: Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
timeFrame: 79 to 93 days after baseline
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.
timeFrame: Study Duration: 21 weeks
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Lighthouse Point
country: United States
facility: Alliance Medical Research
state: Florida
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Chicago
country: United States
facility: UCMC - Center for Clinical Cancer Genetics and Global Health
state: Illinois
city: Ames
country: United States
facility: PMG Research of McFarland Clinic
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: Celiac Disease Center at Columbia University
state: New York
city: Statesville
country: United States
facility: PMG Research of Piedmont Healthcare
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospitals - Center City Campus
state: Pennsylvania
city: Lincoln
country: United States
facility: Ocean State Clinical Research Partners
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: Hermitage
country: United States
facility: Digestive Health Research
state: Tennessee
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: South Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Auchenflower
country: Australia
facility: The Wesley Hospital - The Wesley Research Institute
state: Queensland
city: Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Sippy Downs
country: Australia
facility: Clinical Trials Centre - University of the Sunshine Coast
state: Queensland
city: Woolloongabba
country: Australia
facility: The University of Queensland - Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: Southern Australia
city: Box Hill
country: Australia
facility: Eastern Health-Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: Christchurch
country: New Zealand
facility: Gastroenterology and Endoscopy Specialists
city: Havelock North
country: New Zealand
facility: P3 Research Limited
city: Mount Cook
country: New Zealand
facility: P3 Research Limited
Study officials:
affiliation: ImmusanT, Inc.
name: Robert Anderson, PhD, FRACP
role: STUDY_CHAIR
References:
citation: Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.