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

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ClinicalTrials.gov Identifier: NCT03644069
Recruitment Status : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
ImmusanT, Inc.

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

Condition or disease Intervention/treatment Phase
Celiac Disease Celiac Intestinal Disease Malabsorption Syndromes Gastrointestinal Disease Digestive System Disease Gluten Sensitivity Autoimmune Diseases Biological: Nexvax2 Biological: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Nexvax2 Biological: Nexvax2
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644069


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

Additional Information:
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Responsible Party: ImmusanT, Inc.
ClinicalTrials.gov Identifier: NCT03644069     History of Changes
Other Study ID Numbers: Nexvax2-2006
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Celiac Disease
Autoimmune Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Metabolic Diseases
Immune System Diseases