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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03644069
Recruitment Status : Unknown
Verified March 2019 by ImmusanT, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
ImmusanT, Inc.

Study Description
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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.
Study Design
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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

Arms and Interventions
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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
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
ImmusanT, Inc.
Investigators
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Study Chair: Robert Anderson, PhD, FRACP ImmusanT, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ImmusanT, Inc.
ClinicalTrials.gov Identifier: NCT03644069    
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
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
 Intestinal Diseases
Autoimmune Diseases
Immune System Diseases
Metabolic Diseases