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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04704843
Registration number
NCT04704843
Ethics application status
Date submitted
8/01/2021
Date registered
12/01/2021
Date last updated
3/02/2022
Titles & IDs
Public title
A Study of Guselkumab in Adult Participants With Celiac Disease
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Scientific title
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Response of Guselkumab in Adult Participants With Celiac Disease
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Secondary ID [1]
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2020-003539-40
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Secondary ID [2]
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CR108914
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Celiac Disease
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo
Experimental: Module A (Without Gluten-Challenge): Guselkumab or Placebo - Participants in Module A (without gluten-challenge) will receive intravenous (IV) infusion of guselkumab or matching placebo as induction dose at every 4 weeks through Week 8 followed by subcutaneous (SC) injection of guselkumab or matching placebo at Week 12.
Experimental: Module B (With Gluten-Challenge): Guselkumab or Placebo - Participants in Module B (with gluten-challenge) will receive IV infusion of guselkumab or matching placebo as induction dose at every 4 weeks through Week 8 followed by SC injection of guselkumab or matching placebo at Week 12.
Treatment: Drugs: Guselkumab
Guselkumab will be administered as IV infusion (induction dose) and SC injection.
Treatment: Drugs: Placebo
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.
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Timepoint [1]
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Up to Week 28
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Primary outcome [2]
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Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
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Assessment method [2]
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TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Timepoint [2]
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Up to Week 28
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Primary outcome [3]
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Number of Participants with Clinically Significant Abnormalities in Vital Signs
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Assessment method [3]
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Number of participants with clinically significant vital signs abnormalities including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.
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Timepoint [3]
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Up to Week 28
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Primary outcome [4]
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Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
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Assessment method [4]
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Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.
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Timepoint [4]
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Up to Week 28
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Secondary outcome [1]
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Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
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Assessment method [1]
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Change from baseline in Vh:Cd ratio will be reported.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [2]
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Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
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Assessment method [2]
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Change from baseline in number of IELs will be reported.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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Change from Baseline in Marsh-Oberhuber Scores
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Assessment method [3]
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Change from baseline in marsh-oberhuber scores will be reported. Marsh-Oberhuber score is a classification system which grades histology specimens on 6 levels from normal to total villus atrophy to characterize tissue.
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Timepoint [3]
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Baseline and Week 16
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Secondary outcome [4]
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Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
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Assessment method [4]
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Change from baseline in CDSD scores will be reported. The CDSD is a daily electronic patient-reported outcome (ePRO) assessing the presence or absence of a broad range of celiac disease symptoms (diarrhea, spontaneous bowel movements, abdominal pain, bloating, nausea and tiredness). The CDSD includes 2 types of scores: a weekly symptom-specific severity score and a weekly total score. For each of the symptoms there is a possible score of 0 to 70. The total score for each week is then calculated by dividing each symptom-specific score by 10 and then summing them to get a possible total score of 0 to 70.
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Timepoint [4]
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Baseline and Week 16
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Secondary outcome [5]
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Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
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Assessment method [5]
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Change from baseline in CeD-GSRS will be reported. The CeD-GSRS is a modified version of the gastrointestinal symptom rating scale (GSRS). The GSRS is a questionnaire consisting of 15 symptom-specific items each graded on a 7-point Likert scale each with descriptive anchor. The scores are calculated by taking the mean of items within each of five scales: Abdominal Pain (AP), reflux, diarrhea, indigestion and constipation. The CeD-GSRS assesses 10 questions of the original GSRS. Higher scores represent more severe symptoms.
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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Serum Concentrations of Guselkumab
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Assessment method [6]
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Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.
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Timepoint [6]
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Up to Week 28
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Secondary outcome [7]
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Number of Participants with Antibodies to Guselkumab
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Assessment method [7]
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Number of participants with antibodies to guselkumab will be reported.
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Timepoint [7]
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Up to Week 28
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Secondary outcome [8]
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Number of Participants with Neutralizing Antibodies to Guselkumab
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Assessment method [8]
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Number of participants with neutralizing antibodies to guselkumab will be reported.
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Timepoint [8]
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Up to Week 28
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Secondary outcome [9]
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Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
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Assessment method [9]
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Change from baseline in clinical biomarker hs-CRP will be reported.
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Timepoint [9]
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Baseline, up to Week 28
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Secondary outcome [10]
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Change from Baseline in Clinical Biomarker Fecal Calprotectin
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Assessment method [10]
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Change from baseline in clinical biomarker fecal calprotectin will be reported.
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Timepoint [10]
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Baseline, up to Week 28
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Eligibility
Key inclusion criteria
- Have a body mass index (BMI) 16 to 45 kilogram per meter square (kg/m^2). Underweight
participants (BMI 16 to 18 kg/m^2) may only be included if in the opinion of the
investigator a participant was underweight due to active celiac disease and thus, may
benefit from therapy but yet not be at significantly increased risk due to severe
malabsorption or other conditions
- Physician-diagnosed celiac disease with documented history of biopsy-proven celiac
disease
- Self-reported to be on a gluten-free diet (GFD) for at least 11 consecutive months
prior to enrollment and have the willingness to continue to adhere to the same GFD
while on study
- Willing to take/ingest gluten-containing product at specific study timepoints only (if
assigned to Module B)
- Willing to undergo up to 3 on-study esophagogastroduodenoscopy (EGD) with biopsies
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a history of chronic inflammatory gastrointestinal disease (example, inflammatory
bowel disease, extensive colitis, ulcerative jejunitis, eosinophilic esophagitis)
- Has chronic infectious gastrointestinal illness, or acute infectious gastrointestinal
illness within the 4-week period prior to screening
- Currently has a malignancy or a history of malignancy within 5 years before screening
(with the exception of a non-melanoma skin cancer that has been adequately treated
with no evidence of recurrence for at least 3 months before the first study
intervention administration or cervical carcinoma in situ that has been treated with
no evidence of recurrence for at least 3 months before the first study intervention);
known history of lymphoproliferative disease, including monoclonal gammopathy of
unknown significance, lymphoma, or signs and symptoms suggestive of possible
lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but
not limited to, chronic renal infection, chronic chest infection, recurrent urinary
tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis),
or open, draining, or infected skin wounds or ulcers
- Has had previous treatment with guselkumab
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/09/2021
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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Oklahoma
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared
to placebo in participants with celiac disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04704843
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04704843
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