- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704843
A Study of Guselkumab in Adult Participants With Celiac Disease
January 20, 2022 updated by: Janssen Research & Development, LLC
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
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Lancaster, California, United States, 93534
- Clinical Trials Network
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Michigan
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Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan, LLC
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Wyoming, Michigan, United States, 49519
- West Michigan Clinical Research Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73102
- Hightower Clinical
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Guselkumab will be administered as IV infusion (induction dose) and SC injection.
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
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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.
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Guselkumab will be administered as IV infusion (induction dose) and SC injection.
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 28
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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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Up to Week 28
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Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: Up to Week 28
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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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Up to Week 28
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Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to Week 28
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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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Up to Week 28
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Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Time Frame: Up to Week 28
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Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.
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Up to Week 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
Time Frame: Baseline and Week 16
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Change from baseline in Vh:Cd ratio will be reported.
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Baseline and Week 16
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Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
Time Frame: Baseline and Week 16
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Change from baseline in number of IELs will be reported.
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Baseline and Week 16
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Change from Baseline in Marsh-Oberhuber Scores
Time Frame: Baseline and Week 16
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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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Baseline and Week 16
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Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
Time Frame: Baseline and Week 16
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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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Baseline and Week 16
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Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Time Frame: Baseline and Week 16
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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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Baseline and Week 16
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Serum Concentrations of Guselkumab
Time Frame: Up to Week 28
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Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.
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Up to Week 28
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Number of Participants with Antibodies to Guselkumab
Time Frame: Up to Week 28
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Number of participants with antibodies to guselkumab will be reported.
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Up to Week 28
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Number of Participants with Neutralizing Antibodies to Guselkumab
Time Frame: Up to Week 28
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Number of participants with neutralizing antibodies to guselkumab will be reported.
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Up to Week 28
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Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline, up to Week 28
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Change from baseline in clinical biomarker hs-CRP will be reported.
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Baseline, up to Week 28
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Change from Baseline in Clinical Biomarker Fecal Calprotectin
Time Frame: Baseline, up to Week 28
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Change from baseline in clinical biomarker fecal calprotectin will be reported.
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Baseline, up to Week 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2021
Primary Completion (Actual)
September 13, 2021
Study Completion (Actual)
September 13, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108914
- 2020-003539-40 (EudraCT Number)
- 64304500CLD1001 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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