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

Sponsor
ImmusanT, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03644069
Collaborator
(none)
146
Enrollment
41
Locations
2
Arms
12.8
Anticipated Duration (Months)
3.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 6, 2018
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. [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. [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. [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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • ImmusanT, Inc.

Investigators

  • Study Chair: Robert Anderson, PhD, FRACP, ImmusanT, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ImmusanT, Inc.
ClinicalTrials.gov Identifier:
NCT03644069
Other Study ID Numbers:
  • Nexvax2-2006
First Posted:
Aug 23, 2018
Last Update Posted:
Mar 19, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Celiac Disease
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Autoimmune Diseases

Study Results

No Results Posted as of Mar 19, 2019