Celiac DiseaseNCT03521180
A Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease
An observational study of Celiac Disease, run by Celgene at 2 sites in United States.
Trial summary
This is a model development, open label, no therapeutic treatment, three sequential group, short term-gluten challenge study in subjects with celiac disease. Immune responses are evaluated following gluten challenge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Celiac Disease
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2018to 18 Jul 2019
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of approximately 15 subjects (male or female) with celiac disease will be enrolled. Subjects must be positive for the HLA-DQ2.5+ haplotype. The disease should be well controlled through gluten-free diet. They must have followed a strict gluten free diet prior to screening with no symptoms that would suggest accidental gluten ingestion during that time.
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Male and female subjects of any race between 18 to 65 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Documented diagnosis of celiac disease ≥ 6 months before study entry, based on American College of Gastroenterology 2013 guideline on celiac disease diagnosis and management. The confirmation of a diagnosis of CD should be based on a combination of findings from the medical history, physical examination, serology, and upper endoscopy with histological analysis of multiple biopsies of the duodenum.
- A positive biopsy consistent with celiac disease. Every effort should be made to obtain the biopsy report to support the diagnosis of CD. Prospective subjects should not undergo biopsy for the sole purpose for participating in this trial. And
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- A documented positive gluten-specific serology to tissue transglutaminase (tTG), endomysial antibodies (EMA), and/or gliadin-derived peptides (GDP).
- Group 1 subjects must have been following a gluten-free diet for ≥ 6 months before study entry and have been in remission based on self-reporting and must have negative IgA antibodies to tTG at screening. For Group 2 and 3 the gluten free diet duration may be reduced to a minimum of 3 months. Notification of the changes for Group 2 and 3 will be provided to the site(s).
- Subjects must have HLA DQ2.5 (i.e., DQA1*05/DQB1*02).
- No clinically significant abnormal laboratory test results other than those related to celiac disease as determined by the investigator.
- At the screening visit, must be afebrile, with supine systolic BP: 90 to 140 mmHg, supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm. Eligibility criteria for vital signs performed on Day 0 (or Day 1 pre-gluten challenge) will be at the discretion of the Investigator. In the opinion of the Investigator, subjects with hypertension controlled with a concomitant medication will be allowed in the study.
- Must have a normal or clinically acceptable 12-lead ECG.
- Female subject must have a negative pregnancy test at screening and on Day 0 (or Day 1 pre-gluten challenge).
- Subject must be willing and able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Any significant medical condition, laboratory abnormality, or psychiatric illness, Type 1 diabetes, other than celiac disease, that would prevent the subject from participating in the study.
- Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- Use of any prescribed systemic immune modulator medication within 30 days of the first bread administration.
- The use of prescribed and over-the-counter non-steroidal anti-inflammatory drugs (NSAID) within 14 days of the first bread administration.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first bread administration or 5 half-lives of that investigational drug, if known (whichever is longer).
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- Donated blood or plasma within 8 weeks before the first bread administration to a blood bank or blood donation center.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before dosing, or a positive drug screen reflecting consumption of illicit drugs. For states in which marijuana is legal; prior use of marijuana may be acceptable as long as the screening drug screen is negative. Subjects may be re-screened in case the drug screen tests positive for marijuana. Subjects must refrain from the use of marijuana 2 weeks prior to screening until the end of study.
- History of alcohol abuse (as defined by the current version of the DSM) within 2 years before screening, or a positive alcohol screen.
- Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Any condition that confounds the ability to interpret data from the study.
- Subjects with a history of hypersensitivity or anaphylaxis to gluten.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance
Dallas, Texas, 75247
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Model Development, Clinical Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease.
This is a model development, open label, no therapeutic treatment, three sequential group, short term-gluten challenge study in subjects with celiac disease. Immune responses are evaluated following gluten challenge.
Approximately fifteen subjects with celiac disease will be enrolled in up to three sequential groups (5 subjects per group).
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Gluten, Immune Response, Challenge
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Celiac Disease | Group 1 will start the gluten challenge with 4 slices of white bread once daily for 3 days. Blood will be taken at pre-specified time points for up to 9 days following the start of gluten challenge for biomarker analyses. Based on data from the first 5 subjects, the 2nd group of 5 subjects may: 1) not be needed if the objectives are met; 2) receive gluten at increased quantity (not to exceed 6 slices of bread once daily for 3 days) or have biomarker samples collected at adjusted time points; 3) same as the first 5 subjects; 4) reducing the duration of gluten free diet for a minimum of 3 months instead of 6 month for the Inclusion Criteria # 5;5) subjects may be re-enrolled once. The same applies to the 3rd group of subjects. A notification will be provided to the clinical study site for detailed changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC
The number of gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC will be reported separately by flow cytometry .
Measured: Approximately 10 days
Evaluation of Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by Flow Cytometry
Gliadin specific T cells will be evaluated by flow cytometry using fluorescently labelled HLA-gliadin tetramers that selectively bind to gliadin-specific T-cells.
Measured: Approximately 10 days
Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by ELISPOT
Gliadin specific T cells will be evaluated using Enzyme-linked immunospot (ELISPOT) which measure the number of cells secreting cytokine in response to gliadin binding.
Measured: approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start11 May 2018
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
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.
- More trials run by CelgeneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Ye, PhD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521180
- Sponsor's protocol ID
- NDS-CP-002
- Other IDs
- U1111-1208-7879
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Development, Clinical Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease.
- ClinicalTrials.gov ID
- NCT03521180
- Acronym / sponsor ID
- NDS-CP-002
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Gluten, Immune Response, Challenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 11 May 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.
This is a model development, open label, no therapeutic treatment, three sequential group, short term-gluten challenge study in subjects with celiac disease. Immune responses are evaluated following gluten challenge.
Approximately fifteen subjects with celiac disease will be enrolled in up to three sequential groups (5 subjects per group).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Celiac Disease | – | –Group 1 will start the gluten challenge with 4 slices of white bread once daily for 3 days. Blood will be taken at pre-specified time points for up to 9 days following the start of gluten challenge for biomarker analyses. Based on data from the first 5 subjects, the 2nd group of 5 subjects may: 1) not be needed if the objectives are met; 2) receive gluten at increased quantity (not to exceed 6 slices of bread once daily for 3 days) or have biomarker samples collected at adjusted time points; 3) same as the first 5 subjects; 4) reducing the duration of gluten free diet for a minimum of 3 months instead of 6 month for the Inclusion Criteria # 5;5) subjects may be re-enrolled once. The same applies to the 3rd group of subjects. A notification will be provided to the clinical study site for detailed changes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of approximately 15 subjects (male or female) with celiac disease will be enrolled. Subjects must be positive for the HLA-DQ2.5+ haplotype. The disease should be well controlled through gluten-free diet. They must have followed a strict gluten free diet prior to screening with no symptoms that would suggest accidental gluten ingestion during that time.
Key inclusion criteria (14 listed)
- Male and female subjects of any race between 18 to 65 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Documented diagnosis of celiac disease ≥ 6 months before study entry, based on American College of Gastroenterology 2013 guideline on celiac disease diagnosis and management. The confirmation of a diagnosis of CD should be based on a combination of findings from the medical history, physical examination, serology, and upper endoscopy with histological analysis of multiple biopsies of the duodenum.
- Group 1 subjects must have been following a gluten-free diet for ≥ 6 months before study entry and have been in remission based on self-reporting and must have negative IgA antibodies to tTG at screening. For Group 2 and 3 the gluten free diet duration may be reduced to a minimum of 3 months. Notification of the changes for Group 2 and 3 will be provided to the site(s).
Key exclusion criteria (12 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness, Type 1 diabetes, other than celiac disease, that would prevent the subject from participating in the study.
- Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- Use of any prescribed systemic immune modulator medication within 30 days of the first bread administration.
- The use of prescribed and over-the-counter non-steroidal anti-inflammatory drugs (NSAID) within 14 days of the first bread administration.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first bread administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC
Time frame: Approximately 10 days
The number of gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC will be reported separately by flow cytometry .
Evaluation of Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by Flow Cytometry
Time frame: Approximately 10 days
Gliadin specific T cells will be evaluated by flow cytometry using fluorescently labelled HLA-gliadin tetramers that selectively bind to gliadin-specific T-cells.
Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by ELISPOT
Time frame: approximately 10 days
Gliadin specific T cells will be evaluated using Enzyme-linked immunospot (ELISPOT) which measure the number of cells secreting cytokine in response to gliadin binding.
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 26 Feb 2020.
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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.
Ying Ye, PhD study director
Celgene
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Celgene at 2 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 14 inclusion and 12 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC (time frame: Approximately 10 days). The study lists 3 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 26 Feb 2020.