A Study of Guselkumab in Adult Participants With Celiac Disease

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04704843
• Other study ID #: CR108914
• Secondary ID: 2020-003539-4064
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 17, 2021
• Est. completion date: September 13, 2021

Study information

• Verified date: January 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 13, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• Guselkumab
Guselkumab will be administered as IV infusion (induction dose) and SC injection.
• Placebo
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Locations

Country	Name	City	State
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Clinical Trials Network	Lancaster	California
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Week 28
Primary	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.	Up to Week 28
Primary	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.	Up to Week 28
Primary	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.	Up to Week 28
Secondary	Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio	Change from baseline in Vh:Cd ratio will be reported.	Baseline and Week 16
Secondary	Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).	Change from baseline in number of IELs will be reported.	Baseline and Week 16
Secondary	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.	Baseline and Week 16
Secondary	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.	Baseline and Week 16
Secondary	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.	Baseline and Week 16
Secondary	Serum Concentrations of Guselkumab	Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.	Up to Week 28
Secondary	Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab will be reported.	Up to Week 28
Secondary	Number of Participants with Neutralizing Antibodies to Guselkumab	Number of participants with neutralizing antibodies to guselkumab will be reported.	Up to Week 28
Secondary	Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)	Change from baseline in clinical biomarker hs-CRP will be reported.	Baseline, up to Week 28
Secondary	Change from Baseline in Clinical Biomarker Fecal Calprotectin	Change from baseline in clinical biomarker fecal calprotectin will be reported.	Baseline, up to Week 28