Back to resultsA Study of Guselkumab in Adult Participants With Celiac Disease
Primary Purpose
Celiac Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease
Eligibility Criteria
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
Sites / Locations
- Clinical Trials Network
- Clinical Research Institute of Michigan, LLC
- West Michigan Clinical Research Center
- Hightower Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Module A (Without Gluten-Challenge): Guselkumab or Placebo
Module B (With Gluten-Challenge): Guselkumab or Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
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.
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
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.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
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.
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.
Secondary Outcome Measures
Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
Change from baseline in Vh:Cd ratio will be reported.
Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
Change from baseline in number of IELs will be reported.
Change from Baseline in Marsh-Oberhuber Scores
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.
Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
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.
Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
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.
Serum Concentrations of Guselkumab
Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.
Number of Participants with Antibodies to Guselkumab
Number of participants with antibodies to guselkumab will be reported.
Number of Participants with Neutralizing Antibodies to Guselkumab
Number of participants with neutralizing antibodies to guselkumab will be reported.
Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
Change from baseline in clinical biomarker hs-CRP will be reported.
Change from Baseline in Clinical Biomarker Fecal Calprotectin
Change from baseline in clinical biomarker fecal calprotectin will be reported.
Full Information
NCT ID
NCT04704843
First Posted
January 8, 2021
Last Updated
January 20, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04704843
Brief Title
A Study of Guselkumab in Adult Participants With Celiac Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated. Sponsor decision.
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Module A (Without Gluten-Challenge): Guselkumab or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Module B (With Gluten-Challenge): Guselkumab or Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
Guselkumab will be administered as IV infusion (induction dose) and SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to Week 28
Title
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 28
Title
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Description
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.
Time Frame
Up to Week 28
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Description
Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.
Time Frame
Up to Week 28
Secondary Outcome Measure Information:
Title
Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
Description
Change from baseline in Vh:Cd ratio will be reported.
Time Frame
Baseline and Week 16
Title
Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
Description
Change from baseline in number of IELs will be reported.
Time Frame
Baseline and Week 16
Title
Change from Baseline in Marsh-Oberhuber Scores
Description
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.
Time Frame
Baseline and Week 16
Title
Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
Description
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.
Time Frame
Baseline and Week 16
Title
Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Description
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.
Time Frame
Baseline and Week 16
Title
Serum Concentrations of Guselkumab
Description
Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.
Time Frame
Up to Week 28
Title
Number of Participants with Antibodies to Guselkumab
Description
Number of participants with antibodies to guselkumab will be reported.
Time Frame
Up to Week 28
Title
Number of Participants with Neutralizing Antibodies to Guselkumab
Description
Number of participants with neutralizing antibodies to guselkumab will be reported.
Time Frame
Up to Week 28
Title
Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
Description
Change from baseline in clinical biomarker hs-CRP will be reported.
Time Frame
Baseline, up to Week 28
Title
Change from Baseline in Clinical Biomarker Fecal Calprotectin
Description
Change from baseline in clinical biomarker fecal calprotectin will be reported.
Time Frame
Baseline, up to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials Network
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Guselkumab in Adult Participants With Celiac Disease
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