Celiac DiseasePhase 1NCT03543540
Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease
A Phase 1 study testing Nexvax2 in people with Celiac Disease and Intestinal Disease, run by ImmusanT, Inc. at 3 sites in Australia.
Trial summary
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease, Intestinal Disease, Malabsorption Syndromes
- What is being tested?
- Nexvax2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 May 2018to 10 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Qpharm Pty Ltd
Herston, Queensland, 4006
Linear Clinical Research
Nedlands, Western Australia, 6009
University of the Sunshine Coast
Sippy Downs, Queensland, 4556
About this study
Official title: A Phase 1 Study of Nexvax2 Administered Subcutaneously After a Screening Gluten Food Challenge That Compares Relative Bioavailability With Intradermal Administration in Non-homozygous HLA-DQ2.5+ Adults With Celiac Disease
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
Read the 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.
- Conditions
- Celiac Disease, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Diseases, Metabolic Disease
- Being tested
- Nexvax2, Placebo
- Medical subject headings
- Celiac Disease, Intestinal Diseases, Malabsorption Syndromes, Gastrointestinal Diseases, Digestive System Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexvax2Biological
Nexvax2 injections: 14 in total at twice weekly intervals
PlaceboBiological
Placebo injections: 14 in total at twice weekly intervals
| Study group | Role | What they receive |
|---|---|---|
| Nexvax2 (Arm A) | Experimental | Not described Receives: Biological: Nexvax2 |
| Nexvax2 (Arm B) | Experimental | Not described Receives: Biological: Nexvax2 |
| Nexvax2 Placebo (Arm C) | Placebo comparator | Not described Receives: Biological: Placebo |
| Nexvax2 Placebo (Arm D) | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Nexvax 2 administered subcutaneously (SQ)
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.
Measured: Treatment Period: 7 weeks
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
Blood draws for plasma concentration
Measured: Treatment Period: 7 weeks
Secondary outcomes (4)
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Blood draw collected for cytokines
Measured: Treatment Period: 7 weeks
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for Pharmacokinetic (PK) sample
Measured: Treatment Period: 7 weeks
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK
Measured: Treatment Period: 7 weeks
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK
Measured: Treatment Period: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 May 2018
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmusanT, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Anderson, PhD, FRACP, Study chair, ImmusanT, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543540
- Sponsor's protocol ID
- Nexvax2-1005
- Status last verified
- Sep 2018
- First submitted
- 26 Apr 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Nexvax2 Administered Subcutaneously After a Screening Gluten Food Challenge That Compares Relative Bioavailability With Intradermal Administration in Non-homozygous HLA-DQ2.5+ Adults With Celiac Disease
- ClinicalTrials.gov ID
- NCT03543540
- Acronym / sponsor ID
- Nexvax2-1005
- Conditions
- Celiac Disease, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Diseases, Metabolic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ImmusanT, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nexvax2 (Arm A) | Experimental | Biological: Nexvax2 |
| Nexvax2 (Arm B) | Experimental | Biological: Nexvax2 |
| Nexvax2 Placebo (Arm C) | Placebo comparator | Biological: Placebo |
| Nexvax2 Placebo (Arm D) | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexvax2Nexvax2 injections: 14 in total at twice weekly intervals | Biological | Nexvax2 (Arm A), Nexvax2 (Arm B) |
| PlaceboPlacebo injections: 14 in total at twice weekly intervals | Biological | Nexvax2 Placebo (Arm C), Nexvax2 Placebo (Arm D) |
Primary outcome
Safety of Nexvax 2 administered subcutaneously (SQ)
Time frame: 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
Time frame: Treatment Period: 7 weeks
Blood draws for plasma concentration
4 secondary outcomes
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Time frame: Treatment Period: 7 weeks
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Time frame: Treatment Period: 7 weeks
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Time frame: Treatment Period: 7 weeks
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Time frame: Treatment Period: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- ImmusanTLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Anderson, PhD, FRACP study chair
ImmusanT, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nexvax2 in people with Celiac Disease and Intestinal Disease, run by ImmusanT, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Nexvax 2 administered subcutaneously (SQ) (time frame: Treatment Period: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.