Open Clinical Trials

Inside Stanford Digestive Health - Winter/Spring 2024

Autoimmune Hepatitis

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis NCT05569759

Autoimmune hepatitis (AIH) is treated with a combination of corticosteroids and azathioprine. This trial is evaluating the efficacy of Zetomipzomib a first-in-class, selective immunoproteasome inhibitor that modulates the immune system when it is dysregulated. In this trial, Zetomipzomib will be tested in AIH patients who have active disease despite at least 3 months of therapy or have a flare of AIH after achieving remission.

  • Must have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy for ≥3 months or disease flare after experiencing complete remission induced by standard-of-care treatment, including:
    • Screening ALT values that are 1.25 to 10 times the upper limit of the normal range (ULN)
    • Liver biopsy results with Ishak score (modified HAI) ≥5/18 indicating active AIH, from a biopsy performed at Screening, or within 6 months prior to Screening
    • Mild or no hepatic impairment (Child Pugh category A)
  • Must be willing to use and taper glucocorticoid therapy.

Learn More:

Stanford Study Coordinator: Vyvian Ngo
Phone: 650-498-9125
(PI: Dr. Aparna Goel,

Hepatitis B

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) GSK NCT05630807

Globally, hepatitis B is a major cause of cirrhosis and hepatocellular cancer. In the US, hepatitis B affects up to 2 million individuals. Currently approved therapies can suppress the virus but do not lead to functional cure (clearance of HBsAg). This trial will assess the efficacy of the antisense oligonucleotide bepirovirsen, which inhibits production of viral hepatitis proteins, in leading to functional cure in those taking nucleotide/nucleoside (NA) therapy for hepatitis B. 

  1. >18 years of age
  2. HBeAg negative 
  3. Stable without changes in NA therapy for 6 months 
  4. 100IU/ml <HBsAg >3000 IU/mL
  5. HBV DNA <90 IU/mL
  6. ALT ≤2 x ULN

Learn more:

Stanford Study Coordinator: Akiko Mizuta
Phone: 408-431-7567
(PI: Dr. Mindie Nguyen)

Celiac Disease

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet NCT05353985

Celiac disease affects approximately 1% of the population in the Western world and is characterized by an inappropriate T cell response to dietary gluten. 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.

This multicenter trial will enroll celiac disease patients who meet the following criteria

Inclusion: Has an adequate comprehension of a gluten-free diet (GFD) assessed by the site investigator after review of responses to a knowledge test. The final determination of a participant's adequate comprehension of a GFD is at the discretion of the investigator.

  1. Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).
  2. Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant.
  3. Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
  4. The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.
  5. The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
  6. Have a body mass index (BMI) between 16 and 45 kilogram per meter square (kg/m^2), inclusive.
    Note: Individuals with BMI of 40 to 45 should be discussed with the medical monitor and confirmed to be appropriate for endoscopy according to local site guidelines.
  7. The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1).

Learn more:

Stanford Study Coordinator: Meera Bhargava, MS, ACRC
Phone: 650-721-2665
(PI: Dr. Nielsen Fernandez-Becker,

Crohn's Disease

Investigating the role of human exposome in Crohn’s disease

Crohn’s disease is an inflammatory disorder characterized by dysregulated immune response and gut microbiota in genetically predisposed individuals with environment factors also playing a role.

This Stanford University study aims to identify potential environmental exposure markers that may contribute to the progression of Crohn's disease.  

Eligibility Criteria

  1. To be eligible for the study, you must be:
  2. At least 18 years old
  3. Not pregnant, if female
  4. Able to read and understand English
  5. Diagnosed with Crohn's Disease
  • Your participation varies from 6-12 months where you will use:

-    an exposometer to collect your daily exposures
-    a smartwatch to collect your biometric data
-    keep a food log and collect biological samples

The entire study can be done remotely.

We will be looking to see if this information will help us learn more about individual exposures and how certain airborne particles may be related to the onset or flares of Crohn's disease.

Learn more:

Stanford Study Coordinator: Grace Tan S, ACRC
Phone: 650-725-0169
(PI: Dr. Sarah Streett,

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Winter/Spring 2024