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

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

    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • The Wesley Hospital - The Wesley Research Institute
      • Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute
      • Sippy Downs, Queensland, Australia, 4556
        • Clinical Trials Centre - University of the Sunshine Coast
      • Woolloongabba, Queensland, Australia, 4102
        • The University of Queensland - Princess Alexandra Hospital
    • Southern Australia
      • Adelaide, Southern Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health-Box Hill Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3052
        • The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Auckland, New Zealand, 1010
        • Auckland Clinical Studies
      • Christchurch, New Zealand, 8011
        • Gastroenterology and Endoscopy Specialists
      • Havelock North, New Zealand
        • P3 Research Limited
      • Mount Cook, New Zealand, 6021
        • P3 Research Limited
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Lighthouse Point, Florida, United States, 33064
        • Alliance Medical Research
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Chicago, Illinois, United States, 60637
        • UCMC - Center for Clinical Cancer Genetics and Global Health
    • Iowa
      • Ames, Iowa, United States, 50010
        • PMG Research of McFarland Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
      • Wyoming, Michigan, United States, 49519
        • West Michigan Clinical Research Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices & Research
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
      • New York, New York, United States, 10032
        • Celiac Disease Center at Columbia University
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • PMG Research of Piedmont Healthcare
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospitals - Center City Campus
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Ocean State Clinical Research Partners
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Digestive Health Research
    • Texas
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
    • Utah
      • South Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists

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

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
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

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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