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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03644069




Registration number
NCT03644069
Ethics application status
Date submitted
21/05/2018
Date registered
23/08/2018
Date last updated
19/03/2019

Titles & IDs
Public title
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
Scientific 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
Secondary ID [1] 0 0
Nexvax2-2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Celiac 0 0
Intestinal Disease 0 0
Malabsorption Syndromes 0 0
Gastrointestinal Disease 0 0
Digestive System Disease 0 0
Gluten Sensitivity 0 0
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nexvax2
Other interventions - Placebo

Experimental: Nexvax2 -

Placebo Comparator: Placebo -


Other interventions: Nexvax2
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals

Other interventions: Placebo
Placebo SQ injections: 32 in total, at twice weekly intervals

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. - 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.
Timepoint [1] 0 0
79 to 93 days after baseline
Secondary outcome [1] 0 0
Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten. - Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten.
Timepoint [1] 0 0
79 to 93 days after baseline
Secondary outcome [2] 0 0
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains. - Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten.
Timepoint [2] 0 0
79 to 93 days after baseline
Secondary outcome [3] 0 0
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms. - 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.
Timepoint [3] 0 0
79 to 93 days after baseline
Secondary outcome [4] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2. - 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.
Timepoint [4] 0 0
Study Duration: 21 weeks

Eligibility
Key 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

- Able to read and understand English

- Worsening of GI symptoms in response to an oral gluten challenge

- HLA DQ 2.5 positive
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,Southern AustraliaVIC,WA
Recruitment hospital [1] 0 0
The Wesley Hospital - The Wesley Research Institute - Auchenflower
Recruitment hospital [2] 0 0
Coral Sea Clinical Research Institute - Mackay
Recruitment hospital [3] 0 0
Clinical Trials Centre - University of the Sunshine Coast - Sippy Downs
Recruitment hospital [4] 0 0
The University of Queensland - Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research - Parkville
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4740 - Mackay
Recruitment postcode(s) [3] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
New Zealand
State/province [22] 0 0
Auckland
Country [23] 0 0
New Zealand
State/province [23] 0 0
Christchurch
Country [24] 0 0
New Zealand
State/province [24] 0 0
Havelock North
Country [25] 0 0
New Zealand
State/province [25] 0 0
Mount Cook

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmusanT, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen
(HLA)-DQ 2.5+ adults with celiac disease (CeD).
Trial website
https://clinicaltrials.gov/show/NCT03644069
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Anderson, PhD, FRACP
Address 0 0
ImmusanT, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications