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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
|Placebo Comparator: Placebo||
Placebo SQ injections: 32 in total, at twice weekly intervals
- 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.
- 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.
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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|
- 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
- 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.
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
|Study Chair:||Robert Anderson, PhD, FRACP||ImmusanT, Inc.|
|Responsible Party:||ImmusanT, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Diseases
Immune System Diseases