Celiac DiseasePhase 1NCT04704843
A Study of Guselkumab in Adult Participants With Celiac Disease
A Phase 1 study testing Guselkumab in people with Celiac Disease, run by Janssen Research & Development, LLC at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jun 2021to 13 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Clinical Trials Network
Lancaster, California, 93534
Hightower Clinical
Oklahoma City, Oklahoma, 73102
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
About this study
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
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
- Being tested
- Guselkumab, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Guselkumab will be administered as IV infusion (induction dose) and SC injection.
PlaceboDrug
Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Guselkumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 28
Secondary outcomes (10)
Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
Change from baseline in Vh:Cd ratio will be reported.
Measured: Baseline and Week 16
Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
Change from baseline in number of IELs will be reported.
Measured: Baseline and Week 16
Change from Baseline in Marsh-Oberhuber Scores
Change from baseline in marsh-oberhuber scores will be reported. Marsh-Oberhuber score is a classification system which grades histology specimens on 6 levels from normal to total villus atrophy to characterize tissue.
Measured: Baseline and Week 16
Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
Change from baseline in CDSD scores will be reported. The CDSD is a daily electronic patient-reported outcome (ePRO) assessing the presence or absence of a broad range of celiac disease symptoms (diarrhea, spontaneous bowel movements, abdominal pain, bloating, nausea and tiredness). The CDSD includes 2 types of scores: a weekly symptom-specific severity score and a weekly total score. For each of the symptoms there is a possible score of 0 to 70. The total score for each week is then calculated by dividing each symptom-specific score by 10 and then summing them to get a possible total score of 0 to 70.
Measured: Baseline and Week 16
Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Change from baseline in CeD-GSRS will be reported. The CeD-GSRS is a modified version of the gastrointestinal symptom rating scale (GSRS). The GSRS is a questionnaire consisting of 15 symptom-specific items each graded on a 7-point Likert scale each with descriptive anchor. The scores are calculated by taking the mean of items within each of five scales: Abdominal Pain (AP), reflux, diarrhea, indigestion and constipation. The CeD-GSRS assesses 10 questions of the original GSRS. Higher scores represent more severe symptoms.
Measured: Baseline and Week 16
Serum Concentrations of Guselkumab
Serum concentrations of guselkumab over time, including steady-state concentrations will be reported.
Measured: Up to Week 28
Number of Participants with Antibodies to Guselkumab
Number of participants with antibodies to guselkumab will be reported.
Measured: Up to Week 28
Number of Participants with Neutralizing Antibodies to Guselkumab
Number of participants with neutralizing antibodies to guselkumab will be reported.
Measured: Up to Week 28
Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
Change from baseline in clinical biomarker hs-CRP will be reported.
Measured: Baseline, up to Week 28
Change from Baseline in Clinical Biomarker Fecal Calprotectin
Change from baseline in clinical biomarker fecal calprotectin will be reported.
Measured: Baseline, up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start17 Jun 2021
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Why it stopped: Study terminated. Sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704843
- Sponsor's protocol ID
- CR108914
- Other IDs
- 2020-003539-40, 64304500CLD1001
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2021
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04704843
- Acronym / sponsor ID
- CR108914
- Conditions
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated. Sponsor decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module A (Without Gluten-Challenge): Guselkumab or Placebo | Experimental | Drug: Guselkumab, Drug: PlaceboParticipants 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. |
| Module B (With Gluten-Challenge): Guselkumab or Placebo | Experimental | Drug: Guselkumab, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabGuselkumab will be administered as IV infusion (induction dose) and SC injection. | Drug | Module A (Without Gluten-Challenge): Guselkumab or Placebo, Module B (With Gluten-Challenge): Guselkumab or Placebo |
| PlaceboMatching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection. | Drug | Module A (Without Gluten-Challenge): Guselkumab or Placebo, Module B (With Gluten-Challenge): Guselkumab or Placebo |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 28
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.
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to Week 28
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.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: Up to Week 28
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.
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Time frame: Up to Week 28
Number of participants with clinically significant abnormalities in laboratory safety tests will be reported.
10 secondary outcomes
Change from Baseline in Villus Height to Crypt Depth (Vh:Cd) Ratio
Time frame: Baseline and Week 16
Change from Baseline in Number of Intraepithelial Lymphocytes (IELs).
Time frame: Baseline and Week 16
Change from Baseline in Marsh-Oberhuber Scores
Time frame: Baseline and Week 16
Change from Baseline in Celiac Disease Symptom Diary (CDSD) Scores
Time frame: Baseline and Week 16
Change from Baseline in Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Time frame: Baseline and Week 16
Serum Concentrations of Guselkumab
Time frame: Up to Week 28
Number of Participants with Antibodies to Guselkumab
Time frame: Up to Week 28
Number of Participants with Neutralizing Antibodies to Guselkumab
Time frame: Up to Week 28
Change from Baseline in Clinical Biomarkers High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, up to Week 28
Change from Baseline in Clinical Biomarker Fecal Calprotectin
Time frame: Baseline, up to Week 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guselkumab in people with Celiac Disease, run by Janssen Research & Development, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Week 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.