A Study of Guselkumab in Adult Participants With Celiac D... | NCT04704843

NCT04704843

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2020-003539-40	EudraCT Number
64304500CLD1001	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Module A (Without Gluten-Challenge): Guselkumab or Placebo	Experimental	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.	Drug: Guselkumab Drug: Placebo
Module B (With Gluten-Challenge): Guselkumab or Placebo	Experimental	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.	Drug: Guselkumab Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab	Drug	Guselkumab will be administered as IV infusion (induction dose) and SC injection.	Module A (Without Gluten-Challenge): Guselkumab or Placebo Module B (With Gluten-Challenge): Guselkumab or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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 Outcomes

Measure	Description	Time Frame
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
Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).

Eligibility Module

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

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Network		Lancaster	California	93534	United States
Clinical Research Institute of Michigan, LLC

IPD Sharing Statement Module

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases