Last updated: 05/09/2024 14:30:11
Enabling Study to assess Gluten Sensitivity in Coeliac Disease
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A two-part study to evaluate the relationship between gluten dose and immunological response in patients with Coeliac Disease undergoing gluten challenge and the influence of prior exposure to gluten on subsequent responses to a second challenge using both a double-blind 3-day gluten challenge and a novel open-label intrapatient fixed ascending gluten dose approach
Trial description: This is a two-part enabling study to determine the sensitivity to gluten in participants with Coeliac Disease (CeD) on a gluten free diet (GFD), and the reproducibility of this sensitivity following a washout period in the same set of participants.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Part 1a and Part 1b: Maximum immune response (Interleukin-2 [IL-2]) level observed between 2 to 6 hours after first gluten dose during 3-day gluten challenge
Timeframe: Between 2 to 6 hours post first gluten dose
Part 1a and Part 1b: Area under the curve (AUC) of change from Baseline in IL-2 level over 2 to 6 hours after first gluten dose during 3 day gluten challenge
Timeframe: Baseline Day (1-3) pre gluten challenge and Days (1-3) post gluten challenge (2,4,6 hours)
Part 2a and Part 2b: Maximum IL-2 level observed between 2 to 6 hours after each gluten dose in fixed ascending gluten dose approach
Timeframe: Between 2 to 6 hours post each gluten dose
Part 2a and Part 2b: AUC of change from Baseline in IL-2 level over 2 to 6 hours after each gluten dose in fixed ascending gluten dose approach
Timeframe: Baseline (Day 1) and up to 2 to 6 hours post each gluten dose
Secondary outcomes:
Part 1 and Part 2: Number of participants with maximum overall symptom score and severity over 2 to 6 hours after each gluten dose using Global Symptom Survey (GloSS)
Timeframe: Up to 2 to 6 hours post each gluten dose
Part 1 and Part 2: Number of participants with digestive and overall symptoms at 6 hours after each gluten dose
Timeframe: At 6 hours post each gluten dose
Part 1 and Part 2: Number of participants with adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to 8 months
Part 1 and Part 2: Number of participants with clinically significant changes in vital signs and laboratory parameters
Timeframe: Up to 8 months
Interventions:
Not applicable
Enrollment:
42
Primary completion date:
2022-09-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Coeliac Disease
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2021 to December 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 Years
Accepts healthy volunteers
No
- 18 to 60 years of age inclusive at the time of signing the informed consent.
- Coeliac Disease participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
- History or current evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. With the exception of: i) CeD; ii) History of irritable bowel syndrome (IBS) and Gastroesophageal reflux disease (GERD) in the past. Participants with active, current symptoms of IBS or GERD are not eligible.
- History of food intolerances/allergy other than to gluten and lactose.
Inclusion and exclusion criteria
Inclusion criteria:
- 18 to 60 years of age inclusive at the time of signing the informed consent.
- Coeliac Disease participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
- Participants with a diagnosis of CeD.
- CeD participants must have been following a gluten-free diet for >=6 months before study entry (confirmed by a negative gluten urine dipstick at screening).
- Human leukocyte antigen DQ (HLA-DQ) typing associated with CeD.
- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18.5-29.9 kilogram per meter square (kg/m^2) (inclusive).
- Male or females.
- Participants capable of giving signed informed consent.
Exclusion criteria:
- History or current evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. With the exception of: i) CeD; ii) History of irritable bowel syndrome (IBS) and Gastroesophageal reflux disease (GERD) in the past. Participants with active, current symptoms of IBS or GERD are not eligible.
- History of food intolerances/allergy other than to gluten and lactose.
- Severe acute reactions to sporadic gluten ingestion.
- A positive laboratory confirmation of coronavirus disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of gastrointestinal (GI) surgery (with exception of appendectomy).
- Any clinically relevant abnormality on the screening medical assessment, laboratory examination, or ECG.
- COVID-19 vaccination within 30 days of screening visit (first dose or booster dose). No restrictions will be made to participants receiving the COVID-19 vaccine during the study.
- Use of any immunosuppressive medications within 6 months prior to entry or systemic corticosteroids within 3 months prior to entry.
- Unable to refrain from the use of prescription or non-prescription drugs.
- Females – exclude pregnant women (positive pregnancy test).
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-09-12
Actual study completion date
2022-09-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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