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Celiac Disease Vaccine

Nexvax2 for Autoimmune Diseases

Phase 2
Waitlist Available
Research Sponsored by ImmusanT, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 79 to 93 days after baseline
Awards & highlights

Study Summary

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

Eligible Conditions
  • Autoimmune Diseases
  • Gastrointestinal Disorders
  • Gastrointestinal Disease
  • Gluten Intolerance
  • Malabsorption Syndrome
  • Intestinal Diseases
  • Celiac Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~79 to 93 days after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 79 to 93 days after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
Secondary outcome measures
Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nexvax2Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nexvax2
2015
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

ImmusanT, Inc.Lead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled
Robert Anderson, PhD, FRACPStudy ChairImmusanT, Inc.
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Diablo Clinical Research
ActivMed Practices & Research
Long Island Gastrointestinal Research Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
New York
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I realize the only way to find a cure for celiac disease is through clinical trials.
PatientReceived 1 prior treatment
I have several neurological disorders when I accidentally consume gluten. I have mood change, body pain, anxiety.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How much does it costs? How often I need to take the drug?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
2018. "A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03644069.
All > Celiac Disease
~22 spots leftby Apr 2025
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