Celiac Disease, Coeliac Disease, Digestive System Diseases, Gastrointestinal Disease, Gluten Sensitivity, Intestinal Disease, Malabsorption Syndromes, Metabolic Disease
Conditions
Brief summary
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
Detailed description
A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who, have been following a gluten free diet for at least 12 consecutive months prior to screening. The study will evaluate the safety and tolerability of Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. The study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit.
Interventions
BIOLOGICALPlacebo
Placebo injections: 14 in total at twice weekly intervals
BIOLOGICALNexvax2
Nexvax2 injections: 14 in total at twice weekly intervals
Sponsors
ImmusanT, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 on one occasion during screening. * Able to read and understand English.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Nexvax 2 administered subcutaneously (SQ) | Treatment Period: 7 weeks | Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, 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. |
| Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration | Treatment Period: 7 weeks | Blood draws for plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID | Treatment Period: 7 weeks | Blood draw collected for cytokines |
| Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses. | Treatment Period: 7 weeks | Blood draw collected for Pharmacokinetic (PK) sample |
| Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses. | Treatment Period: 7 weeks | Blood draw collected for PK |
| Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses. | Treatment Period: 7 weeks | Blood draw collected for PK |
Countries
Australia
Outcome results
None listed