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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 : 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.

Tracking Information
First Submitted Date  ICMJE May 21, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE August 6, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Celiac Disease
  • Celiac
  • Intestinal Disease
  • Malabsorption Syndromes
  • Gastrointestinal Disease
  • Digestive System Disease
  • Gluten Sensitivity
  • Autoimmune Diseases
Intervention  ICMJE
  • Biological: Nexvax2
    Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
  • Biological: Placebo
    Placebo SQ injections: 32 in total, at twice weekly intervals
Study Arms  ICMJE
  • Experimental: Nexvax2
    Intervention: Biological: Nexvax2
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03644069
Other Study ID Numbers  ICMJE Nexvax2-2006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ImmusanT, Inc.
Study Sponsor  ICMJE ImmusanT, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert Anderson, PhD, FRACP ImmusanT, Inc.
PRS Account ImmusanT, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP