Clinical trials: Gluten-Sensitive Enteropathy
Celiac Disease
A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
This is a decentralized study to primarily explore a novel objective digital biomarker (i.e., Gluten Dependency Index) for celiac disease-related responses triggered by gluten exposure using a wearable biosensor.
- Trial name
- NCT05686369
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Chugai Pharmaceutical
Celiac Disease
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
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).
- Trial name
- NCT05574010
- Testing
- Cohort 1 in Part A, Cohort 2 in Part A, Group 2 in Part B and Part C
- Where
- 36 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Celiac Disease
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
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).
- Trial name
- PROACTIVE (NCT04424927)
- Testing
- PRV-015
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 388 people
- Sponsor
- Provention Bio, a Sanofi Company
Celiac Disease
Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.
- Trial name
- NCT01560169
- Where
- 10 sites in United States, Canada
- Volunteers
- 110 people
- Sponsor
- Alvine Pharmaceuticals Inc.
Eosinophilic Esophagitis, Celiac Disease
Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.
- Trial name
- NCT04593251
- Testing
- CALY-002
- Where
- 13 sites in Belgium, Finland and 3 more
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Calypso Biotech BV
Celiac Disease, Gluten Sensitivity
Bovine Colostrum to Prevent Absorption of Gluten
To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption. A double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral…
- Conditions
- Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity
- Trial name
- NCT05555446
- Testing
- Bovine colostrum
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Milky Way Life Sciences LLC
Celiac Disease, Non-celiac Gluten Sensitivity
Probiotic BL NCC 2705 and Gluten Sensitivity
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
- Trial name
- NCT03775499
- Testing
- Intervention 1 : BL NCC 2705 + Maltodextrin, Intervention 1 : Maltodextrin, Intervention 2 : BL NCC 2705 + Maltodextrin
- Where
- Netherlands
- Volunteers
- 38 people
- Sponsor
- Société des Produits Nestlé (SPN)
Celiac Disease
A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease
A randomized, double-blind, placebo-controlled, two treatment, parallel group study to investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a gluten challenge in volunteers with celiac disease.
- Trial name
- NCT02679014
- Testing
- RO5459072
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Celiac Disease
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
- Trial name
- NCT03738475
- Testing
- TIMP-GLIA
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Takeda
Celiac Disease
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal
ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy adult volunteers and in patients with well-controlled celiac disease, following a meal that contains gluten.
- Trial name
- FED (NCT00669825)
- Testing
- ALV003
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Alvine Pharmaceuticals Inc.
Intestinal Disease, Inflammatory Bowel Diseases
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate…
- Conditions
- Intestinal Disease, Inflammatory Bowel Diseases, Crohn Disease, Ulcer
- Trial name
- NCT04573959
- Testing
- SV-3 Capsule Endoscopy
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Capso Vision, Inc.
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including…
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- MERIT (NCT07892651)
- Where
- Jordan
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Axiom Bioregistry
Celiac Disease
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
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.
- Trial name
- NCT04243551
- Testing
- Latiglutenase
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Entero Therapeutics
Celiac Disease
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.
- Trial name
- NCT06807463
- Testing
- TEV-53408
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 50 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Celiac Disease
Study of DONQ52 in Active Celiac Disease
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in…
- Trial name
- NCT07239336
- Testing
- Simulated Inadvertent Gluten Exposure (SIGE) capsule, DONQ52
- Where
- 74 sites in United States, Australia and 1 more
- Volunteers
- 92 people
- Sponsor
- Chugai Pharmaceutical
Celiac Disease
Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease
A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.
- Trial name
- NCT02528799
- Testing
- Nexvax2
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 38 people
- Sponsor
- ImmusanT, Inc.
Celiac Disease
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
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…
- Trial name
- NCT05353985
- Testing
- TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- Where
- 102 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Takeda
Celiac Disease
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free…
- Trial name
- NCT01396213
- Testing
- Larazotide Acetate
- Where
- 62 sites in United States, Canada
- Volunteers
- 342 people
- Sponsor
- 9 Meters Biopharma, Inc.
Celiac Disease
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
- Trial name
- NCT00626184
- Testing
- 4 dose levels of ALV003
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Alvine Pharmaceuticals Inc.
Celiac Disease, Coeliac Disease
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate the Interaction Between GSK3915393 and Grapefruit Juice and Itraconazole
This is a 3-part first time into human study (FTIH) study for GSK3915393. Parts A and B of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending and repeat oral doses of GSK3915393 in…
- Trial name
- NCT04604795
- Testing
- GSK3915393 Capsules, GSK3915393 Solution for Infusion, Itraconazole
- Where
- United Kingdom
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline