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 : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : March 19, 2019
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644069
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|Study Chair:||Robert Anderson, PhD, FRACP||ImmusanT, Inc.|