Trials / Unknown
UnknownNCT03644069
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- Sponsor
- ImmusanT, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Celiac Disease
- Celiac
- Intestinal Disease
- Malabsorption Syndromes
- Gastrointestinal Disease
- Digestive System Disease
- Gluten Sensitivity
- Autoimmune Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-08-06
- Primary completion
- 2019-09-01
- Completion
- 2019-09-01
- First posted
- 2018-08-23
- Last updated
- 2019-03-19
Locations
41 sites across 3 countries: United States, Australia, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03644069. Inclusion in this directory is not an endorsement.