A Study of JNJ-64304500 or Guselkumab in Adult Participants With Celiac Disease

Study Purpose

The purpose of this study is to evaluate the safety and tolerability of JNJ-64304500 or guselkumab treatment 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 - Willing to undergo 2 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 JNJ-64304500 or 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 Not yet recruiting
Countries Sweden, United States
Conditions

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

Celiac Disease
Arms & Interventions

Arms

Experimental: Cohort 1: Arm A: JNJ-64304500

Participants will receive subcutaneous (SC) injection of JNJ-64304500 as induction dose at Week 0 and as maintenance dose at every 2 weeks through Week 20.

Placebo Comparator: Cohort 1: Arm B: Placebo for JNJ-64304500

Participants will receive SC injection of matching placebo as induction dose at Week 0 and as maintenance dose at every 2 weeks through Week 20.

Experimental: Cohort 2: Arm C: Guselkumab

Participants will receive intravenous (IV) infusion of guselkumab as induction dose at every 4 weeks through Week 8 followed by SC injection of guselkumab as maintenance dose every 4 weeks up to Week 20.

Placebo Comparator: Cohort 2: Arm D: Placebo for Guselkumab

Participants will receive IV infusion of matching placebo as induction dose at every 4 weeks through Week 8 followed by SC injection of matching placebo as maintenance dose every 4 weeks up to Week 20.

Interventions

Drug: - JNJ-64304500

JNJ-64304500 will be administered as SC injection.

Drug: - Guselkumab

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

Drug: - JNJ-64304500-Placebo

Matching placebo to JNJ-64304500 will be administered as SC injection.

Drug: - Guselkumab-Placebo

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

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

Address

Clinical Trials Network

Lancaster, California, 93534

Winthrop, Massachusetts

Status

Address

Massachusetts General Hospital - Center for Celiac Research and Treatment

Winthrop, Massachusetts, 02152-2731

Chesterfield, Michigan

Status

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Mentor, Ohio

Status

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Hightower Clinical, Oklahoma City, Oklahoma

Status

Address

Hightower Clinical

Oklahoma City, Oklahoma, 73102

International Sites

Gastromottagningen, Stockholm, Sweden

Status

Address

Gastromottagningen

Stockholm, , 18288

Uppsala University, Uppsala, Sweden

Status

Address

Uppsala University

Uppsala, , SE-75185

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.