Clinical trial NCT04704843: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Celiac Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 28
measure: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Week 28
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Week 28
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
timeFrame: Up to Week 28
Secondary outcomes:
measure: Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
timeFrame: Baseline and Week 16
measure: Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
timeFrame: Baseline and Week 16
measure: Change from Baseline in Marsh-Oberhuber Scores
timeFrame: Baseline and Week 16
measure: Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
timeFrame: Baseline and Week 16
measure: Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
timeFrame: Baseline and Week 16
measure: Serum Concentrations of Guselkumab
timeFrame: Up to Week 28
measure: Number of Participants with Antibodies to Guselkumab
timeFrame: Up to Week 28
measure: Number of Participants with Neutralizing Antibodies to Guselkumab
timeFrame: Up to Week 28
measure: Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
timeFrame: Baseline, up to Week 28
measure: Change from Baseline in Clinical Biomarker Fecal Calprotectin
timeFrame: Baseline, up to Week 28
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Clinical Trials Network
state: California
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: