A Study of Guselkumab in Adult Participants With Celiac Disease

NCT04704843 | Withdrawn Phase 1 DMC FDA Drug

• 3 other identifiers: CR1089142020-003539-4064304500CLD1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (4)

• 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 (10)

• Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio

  Baseline and Week 16

• Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).

  Baseline and Week 16

• Change from Baseline in Marsh-Oberhuber Scores

  Baseline and Week 16

• Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores

  Baseline and Week 16

• Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score

  Baseline and Week 16

Study Arms (2)

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

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

Placebo DRUG

Matching placebo to 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Clinical Trials Network

Lancaster, California, 93534, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: June 17, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (4)