Celiac DiseasePhase 2NCT03644069
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
A Phase 2 study testing Nexvax2 in people with Celiac Disease and Celiac, run by ImmusanT, Inc. at 41 sites in 3 countries.
Trial summary
A randomized, double-blind, placebo-controlled clinical study in 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, Celiac, Intestinal Disease
- 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
- 146 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 6 Aug 2018to Sep 2019
- Phase
- Phase 2
- 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
- Able to read and understand English
- Worsening of GI symptoms in response to an oral gluten challenge
- HLA DQ 2.5 positive
Who cannot join
- 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.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States28 sites
PMG Research of McFarland Clinic
Ames, Iowa, 50010
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
UCMC - Center for Clinical Cancer Genetics and Global Health
Chicago, Illinois, 60637
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Drug Trials America
Hartsdale, New York, 10530
Digestive Health Research
Hermitage, Tennessee, 37076
Grand Teton Research Group
Idaho Falls, Idaho, 83404
University of Iowa
Iowa City, Iowa, 52242
AB Clinical Trials
Las Vegas, Nevada, 89119
Alliance Medical Research
Lighthouse PT, Florida, 33064
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464
Celiac Disease Center at Columbia University
New York, New York, 10032
Thomas Jefferson University Hospitals - Center City Campus
Philadelphia, Pennsylvania, 19107
ActivMed Practices & Research
Portsmouth, New Hampshire, 03801
Mayo Clinic
Rochester, Minnesota, 55905
Advanced Research Institute
South Ogden, Utah, 84405
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
PMG Research of Piedmont Healthcare
Statesville, North Carolina, 28625
Center for Digestive Health
Troy, Michigan, 48098
Diablo Clinical Research
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226
Heartland Research Associates
Wichita, Kansas, 67207
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
Australia9 sites
Royal Adelaide Hospital
Adelaide, Southern Australia, 5000
The Wesley Hospital - The Wesley Research Institute
Auchenflower, Queensland, 4066
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128
Coral Sea Clinical Research Institute
Mackay, Queensland, 4740
Alfred Hospital
Melbourne, Victoria, 3004
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, 3052
Clinical Trials Centre - University of the Sunshine Coast
Sippy Downs, Queensland, 4556
The University of Queensland - Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand4 sites
Auckland Clinical Studies
Auckland, 1010
Gastroenterology and Endoscopy Specialists
Christchurch, 8011
P3 Research Limited
Havelock North
P3 Research Limited
Mount Cook, 6021
About this study
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
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
Read the 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
- Being tested
- Nexvax2, Placebo
- Medical subject headings
- Celiac Disease, Intestinal Diseases, Malabsorption Syndromes, Gastrointestinal Diseases, Digestive System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexvax2Biological
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
PlaceboBiological
Placebo SQ injections: 32 in total, at twice weekly intervals
| Study group | Role | What they receive |
|---|---|---|
| Nexvax2 | Experimental | Not described Receives: Biological: Nexvax2 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 79 to 93 days after baseline
Secondary outcomes (4)
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.
Measured: 79 to 93 days after baseline
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.
Measured: 79 to 93 days after baseline
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.
Measured: 79 to 93 days after baseline
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.
Measured: Study Duration: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start6 Aug 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
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
- NCT03644069
- Sponsor's protocol ID
- Nexvax2-2006
- Status last verified
- Mar 2019
- First submitted
- 21 May 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tye-Din JA, Daveson AJM, Goel G, Goldstein KE, Hand HL, Neff KM, Popp A, Taavela J, Maki M, Isola J, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Efficacy and safety of gluten peptide-based antigen-specific immunotherapy (Nexvax2) in adults with coeliac disease after bolus exposure to gluten (RESET CeD): an interim analysis of a terminated randomised, double-blind, placebo-controlled phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):446-457. doi: 10.1016/S2468-1253(22)00428-9. Epub 2023 Mar 7.
PubMed 36898393Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.
PubMed 33239013
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03644069
- Acronym / sponsor ID
- Nexvax2-2006
- Conditions
- Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- ImmusanT, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 23 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nexvax2 | Experimental | Biological: Nexvax2 |
| Placebo | 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 (7 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
- Able to read and understand English
Key exclusion criteria (8 listed)
- 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.
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 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals | Biological | Nexvax2 |
| PlaceboPlacebo SQ injections: 32 in total, at twice weekly intervals | Biological | Placebo |
Primary outcome
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.
4 secondary outcomes
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
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
Time frame: 79 to 93 days after baseline
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
Time frame: 79 to 93 days after baseline
Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2.
Time frame: Study Duration: 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 36898393Tye-Din JA, Daveson AJM, Goel G, Goldstein KE, Hand HL, Neff KM, Popp A, Taavela J, Maki M, Isola J, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Efficacy and safety of gluten peptide-based antigen-specific immunotherapy (Nexvax2) in adults with coeliac disease after bolus exposure to gluten (RESET CeD): an interim analysis of a terminated randomised, double-blind, placebo-controlled phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):446-457. doi: 10.1016/S2468-1253(22)00428-9. Epub 2023 Mar 7.
- Derived from this study: PubMed 33239013Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.
- 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.
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexvax2 in people with Celiac Disease and Celiac, run by ImmusanT, Inc. at 41 sites in 3 countries.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Australia, New Zealand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. (time frame: 79 to 93 days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644069, which also lists 2 linked publications.
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 19 Mar 2019.