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

NCT03644069 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Nexvax2-2006
• Study Type: interventional
• Target: 146
• Locations: 3 countries
• Sites: 41

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after 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.

  79 to 93 days after baseline

• Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.

  79 to 93 days after baseline

• Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.

  Study Duration: 21 weeks

Study Arms (2)

Nexvax2

EXPERIMENTAL

Biological: Nexvax2

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Nexvax2 BIOLOGICAL

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

Nexvax2

Placebo BIOLOGICAL

Placebo SQ injections: 32 in total, at twice weekly intervals

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmusanT, Inc.: lead

Study Sites (41)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Alliance Medical Research

Lighthouse PT, Florida, 33064, United States

Location

Grand Teton Research Group

Idaho Falls, Idaho, 83404, United States

Location

UCMC - Center for Clinical Cancer Genetics and Global Health

Chicago, Illinois, 60637, United States

Location

PMG Research of McFarland Clinic

Ames, Iowa, 50010, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Celiac Disease Center at Columbia University

New York, New York, 10032, United States

Location

PMG Research of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

Location

Thomas Jefferson University Hospitals - Center City Campus

Philadelphia, Pennsylvania, 19107, United States

Location

Ocean State Clinical Research Partners

Lincoln, Rhode Island, 02865, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Digestive Health Research

Hermitage, Tennessee, 37076, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Advanced Research Institute

South Ogden, Utah, 84405, United States

Location

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

The Wesley Hospital - The Wesley Research Institute

Auchenflower, Queensland, 4066, Australia

Location

Coral Sea Clinical Research Institute

Mackay, Queensland, 4740, Australia

Location

Clinical Trials Centre - University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

The University of Queensland - Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, Southern Australia, 5000, Australia

Location

Eastern Health-Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research

Parkville, Victoria, 3052, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Auckland Clinical Studies

Auckland, 1010, New Zealand

Location

Gastroenterology and Endoscopy Specialists

Christchurch, 8011, New Zealand

Location

P3 Research Limited

Havelock North, New Zealand

Location

P3 Research Limited

Mount Cook, 6021, New Zealand

Location

Related Publications (2)

• Tye-Din JA, Daveson AJM, Goel G, Goldstein KE, Hand HL, Neff KM, Popp A, Taavela J, Maki M, Isola J, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Efficacy and safety of gluten peptide-based antigen-specific immunotherapy (Nexvax2) in adults with coeliac disease after bolus exposure to gluten (RESET CeD): an interim analysis of a terminated randomised, double-blind, placebo-controlled phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):446-457. doi: 10.1016/S2468-1253(22)00428-9. Epub 2023 Mar 7.

  PMID: 36898393 DERIVED

• 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.

  PMID: 33239013 DERIVED

Related Links

• ImmusanT

MeSH Terms

Conditions

Celiac Disease; Intestinal Diseases; Malabsorption Syndromes; Gastrointestinal Diseases; Digestive System Diseases; Autoimmune Diseases

Interventions

Nexvax2

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases

Study Officials

• Robert Anderson, PhD, FRACP

  ImmusanT, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: August 23, 2018
• Study Start: August 6, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (28); AU (9); NZ (4)