Celiac DiseasePhase 2NCT03738475
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
A Phase 2 study testing TIMP-GLIA in people with Celiac Disease, run by Takeda at 8 sites in United States.
Trial summary
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- TIMP-GLIA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Nov 2018to 22 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit.
- Biopsy-confirmed CD (intestinal histology showing villous atrophy).
- Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or results are not available.
- Self-reported to be on a GFD for at least 6 months prior to Screening and agree to continue GFD throughout study, with the exception of the oral gluten challenge.
- Normal or negative celiac serology, at screening, defined as:
- Measurable total serum immunoglobulin A (IgA) AND
Show all 9Show fewer
- Negative or weak positive tissue transglutaminase (tTG) IgA titer OR
- If IgA deficient, defined by a serum IgA level of < 3 mg/dL, negative or weak positive DGP- IgG titer.
- 6. Vh:Cd ≥ 1.5 on screening biopsy.
Who cannot join
- Positive for only HLA-DQ8.
- History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye.
- Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the investigator.
- Untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (Los Angeles Classification ≥ Grade C), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis.
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior Dose 1, any dose of corticosteroids within 30 days of Day 1, or high dose inhaled corticosteroids [> 960 µg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Presence or history of celiac-associated thyroid disease or Type 1 diabetes, regardless of current treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rapid Medical Research
Beachwood, Ohio, 44122
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Advanced Clinical Research
Meridian, Idaho, 83642
Mayo Clinic
Rochester, Minnesota, 55905
Prism Clinical Research
Saint Paul, Minnesota, 55114
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Pharmacodynamics, Efficacy, and Pharmacokinetics of TIMP-GLIA in Subjects With Well-controlled Celiac Disease Undergoing Oral Gluten Challenge
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial to assess the safety, pharmacodynamics, efficacy, and PK, of TIMP-GLIA in subjects with well-controlled celiac disease (CD) following an oral gluten challenge. Subjects aged 18 to 70 years inclusive, with documented history of biopsy-proven confirmed CD, and on a gluten-free diet (GFD) for a minimum of 6 months, will be screened. Subjects who meet all inclusion and no exclusion criteria, and provide written informed consent, will be randomized within 45 days after Screening to receive 2 intravenous (IV) infusions of TIMP-GLIA, 8 mg/kg up to a maximum of 650 mg or placebo (normal saline) in a 1:1 ratio. Treatment with drug or placebo will be followed by 14 days gluten challenge.
- Conditions
- Celiac Disease
- Being tested
- TIMP-GLIA, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIMP-GLIADrug
Also called TAK-101
8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.
PlaceboDrug
Also called 0.9% sodium chloride (normal saline)
Administered intravenously on days 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| TIMP-GLIA | Experimental | 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. Receives: Drug: TIMP-GLIA |
| Placebo | Placebo comparator | Normal saline administered intravenously on days 1 and 8. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20
The spots formed by interferon-gamma-secreting T-cells were counted with an automated ELISPOT analyzer. The average spot-forming units (SFU) per antigen was calculated. A response was considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Peripheral blood mononuclear cell is PBMC.
Measured: Baseline (Day 15/Day 1), Day 20
Secondary outcomes (16)
Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20
Gliadin-specific T cell proliferation was determined by ELISA test. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15).
Measured: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20
Gliadin-specific T Cell cytokine secretion was determined by ELISA test. Gliadin-specific cytokine included interferon gamma (IFN-γ), interleukin (IL) 1-beta (1-β), IL-10, IL-12, IL-13, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor alpha (TNF-α). Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). A negative change from baseline value was reported when the observed sample response was less than the observed background response.
Measured: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20
Change from baseline value for Gut-Homing cells like CD4, CD8 and Gamma Delta T-cells were reported. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Phenotype (unique cell population) for CD8 cell is EM CD8 > aE+b7hi > aE+b7hiCD38+, for CD4 is EM Th > a4+b7hi > a4+b7hiCD38+ and for Gamma Delta T-cells is TCRgd T cells > aE+b7hi > aE+b7hiCD38+ in this outcome measure.
Measured: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29
Attenuation of the effects of gluten exposure was assessed by measuring the change from baseline in villous height (Vh) to crypt depth (Cd) ratio after 29 days of gluten challenge. Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Measured: Baseline (Screening), Day 29
Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29
Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease.
Measured: Day 29
Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29
IELs were white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes was associated with celiac disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Measured: Baseline (Screening), Day 29
Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment
The CSI were clinically oriented, easily administered, questionnaires with 16 items. The modified CSI (6-items) was derived from a subset of questions from the CSI questionnaire, including the diarrhea, nausea, rumbling in stomach, stomach felt bloated, diarrhea and low energy level abdominal pain domains (a total of 6 questions), which were each assessed on a scale of 1 to 5- none of the time, a little of the time, some of the time, most of the time and all of the time respectively. Higher CSI scores correlate with more severe CD symptoms. It is to be used to assess symptoms before, during, and after the oral gluten challenge. Here D refers to Day.
Measured: Days 15, 20, 29 and 35
Plasma Concentrations of TIMP-GLIA
Measured: Day 8: 0 hours (pre-infusion), end of infusion, and at 2 hours post-infusion
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Measured: From the first dose of study drug up to Day 35
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: From the first dose of study drug up to Day 35
Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values
Measured: From the first dose of study drug up to Day 35
Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35
Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Measured: Baseline (Screening), Days 8, 15, 20, 29, and 35
Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15
Baseline was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), Days 2, 8, 9, and 15
Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15
Baseline was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1) , Days 2, 8, 9, and 15
Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35
Baseline was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), Days 15, 20, 29, and 35
Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15
Baseline was defined as Day 1 pre-dose. A negative change from baseline value was reported when the observed sample response was less than the observed background response.
Measured: Baseline (Day 1), Days 2, 8, 9, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start11 Nov 2018
- Primary completion24 Jun 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Model description
- Randomized double-blind placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COUR Pharmaceutical Development Company, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738475
- Sponsor's protocol ID
- TGLIA-5.002
- Status last verified
- Jul 2020
- First submitted
- 9 Nov 2018
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Publications
Kelly CP, Murray JA, Leffler DA, Getts DR, Bledsoe AC, Smithson G, First MR, Morris A, Boyne M, Elhofy A, Wu TT, Podojil JR, Miller SD; TAK-101 Study Group. TAK-101 Nanoparticles Induce Gluten-Specific Tolerance in Celiac Disease: A Randomized, Double-Blind, Placebo-Controlled Study. Gastroenterology. 2021 Jul;161(1):66-80.e8. doi: 10.1053/j.gastro.2021.03.014. Epub 2021 Mar 17.
PubMed 33722583
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Safety, Pharmacodynamics, Efficacy, and Pharmacokinetics of TIMP-GLIA in Subjects With Well-controlled Celiac Disease Undergoing Oral Gluten Challenge
- ClinicalTrials.gov ID
- NCT03738475
- Acronym / sponsor ID
- TGLIA-5.002
- Conditions
- Celiac Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- COUR Pharmaceutical Development Company, Inc.
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial to assess the safety, pharmacodynamics, efficacy, and PK, of TIMP-GLIA in subjects with well-controlled celiac disease (CD) following an oral gluten challenge. Subjects aged 18 to 70 years inclusive, with documented history of biopsy-proven confirmed CD, and on a gluten-free diet (GFD) for a minimum of 6 months, will be screened. Subjects who meet all inclusion and no exclusion criteria, and provide written informed consent, will be randomized within 45 days after Screening to receive 2 intravenous (IV) infusions of TIMP-GLIA, 8 mg/kg up to a maximum of 650 mg or placebo (normal saline) in a 1:1 ratio. Treatment with drug or placebo will be followed by 14 days gluten challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| TIMP-GLIA | Experimental | Drug: TIMP-GLIA8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline administered intravenously on days 1 and 8. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit.
- Biopsy-confirmed CD (intestinal histology showing villous atrophy).
- Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or results are not available.
- Self-reported to be on a GFD for at least 6 months prior to Screening and agree to continue GFD throughout study, with the exception of the oral gluten challenge.
- Measurable total serum immunoglobulin A (IgA) AND
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| TIMP-GLIAAlso: TAK-1018 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. | Drug | TIMP-GLIA |
| PlaceboAlso: 0.9% sodium chloride (normal saline)Administered intravenously on days 1 and 8. | Drug | Placebo |
Primary outcome
Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20
Time frame: Baseline (Day 15/Day 1), Day 20
The spots formed by interferon-gamma-secreting T-cells were counted with an automated ELISPOT analyzer. The average spot-forming units (SFU) per antigen was calculated. A response was considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Peripheral blood mononuclear cell is PBMC.
16 secondary outcomes
Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20
Time frame: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20
Time frame: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20
Time frame: Baseline (Day 15/Day 1), Day 20
Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29
Time frame: Baseline (Screening), Day 29
Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29
Time frame: Day 29
Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29
Time frame: Baseline (Screening), Day 29
Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment
Time frame: Days 15, 20, 29 and 35
Plasma Concentrations of TIMP-GLIA
Time frame: Day 8: 0 hours (pre-infusion), end of infusion, and at 2 hours post-infusion
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: From the first dose of study drug up to Day 35
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: From the first dose of study drug up to Day 35
Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values
Time frame: From the first dose of study drug up to Day 35
Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35
Time frame: Baseline (Screening), Days 8, 15, 20, 29, and 35
Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15
Time frame: Baseline (Day 1), Days 2, 8, 9, and 15
Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15
Time frame: Baseline (Day 1) , Days 2, 8, 9, and 15
Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35
Time frame: Baseline (Day 1), Days 15, 20, 29, and 35
Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15
Time frame: Baseline (Day 1), Days 2, 8, 9, and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33722583Kelly CP, Murray JA, Leffler DA, Getts DR, Bledsoe AC, Smithson G, First MR, Morris A, Boyne M, Elhofy A, Wu TT, Podojil JR, Miller SD; TAK-101 Study Group. TAK-101 Nanoparticles Induce Gluten-Specific Tolerance in Celiac Disease: A Randomized, Double-Blind, Placebo-Controlled Study. Gastroenterology. 2021 Jul;161(1):66-80.e8. doi: 10.1053/j.gastro.2021.03.014. Epub 2021 Mar 17.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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.
Medical Director Clinical Science study director
Takeda
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIMP-GLIA in people with Celiac Disease, run by Takeda at 8 sites in United States.
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 9 inclusion and 6 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 (time frame: Baseline (Day 15/Day 1), Day 20). 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 NCT03738475, which also lists 1 linked publication.
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 12 Aug 2020.