A Study of Guselkumab in Adult Participants With Celiac Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04704843
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Finland, France, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Module A (Without Gluten-Challenge): Guselkumab or Placebo

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.

Experimental: Module B (With Gluten-Challenge): Guselkumab or Placebo

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.

Interventions

Drug: - Guselkumab

Guselkumab will be administered as IV infusion (induction dose) and SC injection.

Drug: - Placebo

Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Trials Network, Lancaster, California

Status

Recruiting

Address

Clinical Trials Network

Lancaster, California, 93534

Mass General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Mass General Hospital

Boston, Massachusetts, 02114

Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Recruiting

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Withdrawn

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Mentor, Ohio

Status

Withdrawn

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Hightower Clinical, Oklahoma City, Oklahoma

Status

Recruiting

Address

Hightower Clinical

Oklahoma City, Oklahoma, 73102

Digestive Disease Specialists Inc, Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112

Vanderbilt, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt

Nashville, Tennessee, 37232

Velocity Clinical Research Spokane, Spokane, Washington

Status

Not yet recruiting

Address

Velocity Clinical Research Spokane

Spokane, Washington, 99202

International Sites

Royal Adelaide Hospital, Adelaide, Australia

Status

Not yet recruiting

Address

Royal Adelaide Hospital

Adelaide, , 5000

Auchenflower, Australia

Status

Not yet recruiting

Address

The Wesley - St Andrew's Research Institute

Auchenflower, , 4066

The Alfred Hospital, Melbourne, Australia

Status

Not yet recruiting

Address

The Alfred Hospital

Melbourne, , 3004

Coral Sea Clinical Research Institute, North Mackay, Australia

Status

Withdrawn

Address

Coral Sea Clinical Research Institute

North Mackay, , 4740

Royal Melbourne Hospital, Parkville, Australia

Status

Not yet recruiting

Address

Royal Melbourne Hospital

Parkville, , 3050

Sunshine Coast University Hospital, Sippy Downs, Australia

Status

Not yet recruiting

Address

Sunshine Coast University Hospital

Sippy Downs, , 4556

Helsingin Yliopistollinen Keskussairaala, Helsinki, Finland

Status

Not yet recruiting

Address

Helsingin Yliopistollinen Keskussairaala

Helsinki, , 00029

Clinical Research Services Turku - CRST, Helsinki, Finland

Status

Not yet recruiting

Address

Clinical Research Services Turku - CRST

Helsinki, ,

Clinical Research Services Turku - CRST, Turku, Finland

Status

Not yet recruiting

Address

Clinical Research Services Turku - CRST

Turku, , FI-20520

CHRU Lille, Lille Cedex, France

Status

Not yet recruiting

Address

CHRU Lille

Lille Cedex, , 59037

Hôpital Européen Georges Pompidou, Paris, France

Status

Not yet recruiting

Address

Hôpital Européen Georges Pompidou

Paris, , 75015

Danderyds Sjukhus, Stockholm, Sweden

Status

Not yet recruiting

Address

Danderyds Sjukhus

Stockholm, , 182 88

Akademiska Sjukhuset, Uppsala, Sweden

Status

Not yet recruiting

Address

Akademiska Sjukhuset

Uppsala, , 751 85

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