Today we’re going to look at the ongoing studies and clinical trials specific to celiac disease in adults.
The following list has been curated by evaluating the current Phase 2 and 3 clinical trials for celiac disease in adults conducted in the United States. Please note that the dates provided are approximate and may be subject to change. This list primarily includes studies that have been updated within the past 12 months.
This series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
So now let’s jump into the list of Celiac Disease Clinical Trials!
Quick View Table of Celiac Disease Clinical Trials
Celiac Disease Clinical Trials:
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
- Sponsor: Provention Bio, a Sanofi Company
- This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
- Interventions: BIOLOGICAL: PRV-015 / OTHER: Placebo
- Primary Outcomes Measures: Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire, Celiac Disease Patient-Reported Outcome (CeD PRO), 24 weeks
Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet
- Sponsor: Takeda
- “The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.”
- Interventions: DRUG: Placebo, DRUG: TAK-101, DIETARY_SUPPLEMENT: Gluten
- Primary Outcomes Measures: Change From Baseline in Interferon-gamma Spot Forming Units (IFN-γ SFUs) in Human Leukocyte Antigens Density Quotient (HLA-DQ2-positive) Participants Based on Results of a Gliadin-Specific Enzyme-Linked Immunospot (ELISpot) Assay, IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood., Baseline (Day 15, or Day 1 in the absence of Day 15) to Week 3 (Day 20)
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)nia
- Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).
- Interventions: DRUG: Cohort 1 in Part A|DRUG: Cohort 2 in Part A|OTHER: Placebo: Group 1 in Part B and Part C|DRUG: Group 2 in Part B and Part C|DRUG: Group 3 in Part B and Part C|DRUG: Group 4 in Part B and Part C
- Primary Outcomes Measures: Incidence and severity of TEAEs as assessed by common terminology criteria for adverse events (CTCAE) in Part A, Primary endpoint in Part A. CTCAE is a scale with 5 grades to assess AE severity., 28 days|Change in magnitude of IL-2 response pre- and post-GC in peripheral blood in Part B, Primary endpoint in Part B, Baseline to Day 15|Change in magnitude of IL-2 response pre- and post-GC in peripheral blood, Primary endpoint in Part C, 0 (pre-GC) and 4 hours post-GC on Day 15
Study of Latiglutenase in T1D/CD Patients
- Sponsor: 9 Meters Biopharma, Inc.
- To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
- Interventions: DRUG: Larazotide|DRUG: Matching Placebo
- Primary Outcomes Measures: Proportion of subjects who are binary responders, Reduction in CeD PRO Abdominal Domain scores, 12 weeks
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
- This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily in subjects with schizophrenia.
- Interventions: DRUG: Xanomeline and Trospium Chloride Capsules
- Primary Outcomes Measures: Incidence of treatment-emergent adverse events (TEAEs), From initial dose to safety follow-up visit (54 weeks) or early termination.
- Sponsor: Karuna Therapeutics
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
- Sponsor: Immunogenics, LLC
- This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.
- Interventions: DRUG: Latiglutenase|OTHER: Placebo
- Primary Outcomes Measures: Symptom Severity Reduction, The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo., 6 months
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
- Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
- Interventions: DRUG: KAN-101|DRUG: Placebo
- Primary Outcomes Measures: Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge (GC), Vh:Cd is the ratio of villous height to crypt depth, a histological assessment, 29 days
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
- Sponsor: Takeda
- The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
- Interventions: DRUG: TAK-062|DIETARY_SUPPLEMENT: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar|DRUG: TAK-062 Placebo|DIETARY_SUPPLEMENT: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- Primary Outcomes Measures: Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score from Baseline to Week 12, CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate severe symptoms., Baseline (Week -1) to Week 12
Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission
- Sponsor: Massachusetts General Hospital
- “Subjects include: aged 18 to 75 years, inclusive, have biopsy-confirmed disease that is clinically inactive as determined by negative celiac disease (CeD) serology and histology (determined via endoscopy at time of screening), have followed a gluten-free diet (GFD) for ≥6 months as reported by the subject, and be human leukocyte antigen (HLA)-DQ2.5 and/or HLA-DQ8 positive. Study involves the following randomized intervention; 10g gluten + 200mg of Ritlecitinib or placebo”
- Interventions: DRUG: Ritlecitinib|DRUG: Placebo|OTHER: Gluten
- Primary Outcomes Measures: Change in Small Intestinal Histology based on Vh:Cd ratio, Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease histological assessments related to villus height to crypt depth ratio \[Vh:Cd\], Through study completion, average of 1 year.|Patient Reported Outcome Surveys (CeD PRO survey evaluation), Patient Reported Outcomes (PROs) – CeD PRO evaluation of gluten challenge-triggered symptoms, Through study completion, average of 1 year.
Potential Guideline That May Be Affected Includes:
- Diagnosis and Management of Celiac Disease
- American Gastroenterological Association (AGA)
- Published: January 5, 2024
There you have it – a list of Phase 3 Clinical Trials for Celiac Disease as of June 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.