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

Primary Purpose

Celiac Disease, Celiac, Intestinal Disease

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nexvax2
Placebo
Sponsored by
ImmusanT, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Diablo Clinical Research
  • Stamford Therapeutics Consortium
  • Alliance Medical Research
  • Grand Teton Research Group
  • UCMC - Center for Clinical Cancer Genetics and Global Health
  • PMG Research of McFarland Clinic
  • University of Iowa
  • Heartland Research Associates
  • Clinical Research Institute of Michigan
  • Center for Digestive Health
  • West Michigan Clinical Research Center
  • Mayo Clinic
  • AB Clinical Trials
  • ActivMed Practices & Research
  • Long Island Gastrointestinal Research Group
  • Drug Trials America
  • Celiac Disease Center at Columbia University
  • PMG Research of Piedmont Healthcare
  • PMG Research of Winston-Salem, LLC
  • Great Lakes Gastroenterology Research
  • Thomas Jefferson University Hospitals - Center City Campus
  • Ocean State Clinical Research Partners
  • Omega Medical Research
  • Coastal Carolina Research
  • Digestive Health Research
  • Texas Digestive Disease Consultants
  • Advanced Research Institute
  • Allegiance Research Specialists
  • The Wesley Hospital - The Wesley Research Institute
  • Coral Sea Clinical Research Institute
  • Clinical Trials Centre - University of the Sunshine Coast
  • The University of Queensland - Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Eastern Health-Box Hill Hospital
  • Alfred Hospital
  • The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
  • Sir Charles Gairdner Hospital
  • Auckland Clinical Studies
  • Gastroenterology and Endoscopy Specialists
  • P3 Research Limited
  • P3 Research Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nexvax2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 21, 2018
Last Updated
March 15, 2019
Sponsor
ImmusanT, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03644069
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmusanT, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Disease, Gluten Sensitivity, Autoimmune Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nexvax2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Nexvax2
Intervention Description
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo SQ injections: 32 in total, at twice weekly intervals
Primary Outcome Measure Information:
Title
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
Description
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.
Time Frame
79 to 93 days after baseline
Secondary Outcome Measure Information:
Title
Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.
Description
Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten.
Time Frame
79 to 93 days after baseline
Title
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
Description
Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten.
Time Frame
79 to 93 days after baseline
Title
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
Description
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.
Time Frame
79 to 93 days after baseline
Title
Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.
Description
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.
Time Frame
Study Duration: 21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Anderson, PhD, FRACP
Organizational Affiliation
ImmusanT, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Alliance Medical Research
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Grand Teton Research Group
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
UCMC - Center for Clinical Cancer Genetics and Global Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
PMG Research of McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
ActivMed Practices & Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Celiac Disease Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
PMG Research of Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Great Lakes Gastroenterology Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Thomas Jefferson University Hospitals - Center City Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Ocean State Clinical Research Partners
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Carolina Research
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Digestive Health Research
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Advanced Research Institute
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
The Wesley Hospital - The Wesley Research Institute
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Coral Sea Clinical Research Institute
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Facility Name
Clinical Trials Centre - University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
The University of Queensland - Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
Southern Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Health-Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Auckland Clinical Studies
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Gastroenterology and Endoscopy Specialists
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
P3 Research Limited
City
Havelock North
Country
New Zealand
Facility Name
P3 Research Limited
City
Mount Cook
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33239013
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.
Results Reference
derived

Learn more about this trial

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

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