Guest article by Elizabeth Sefton, PhD, Scientific Program Manager; Marissa Dobry, Research Associate, Clinical Trials; and Joaquin Tabera, Clinical Research Coordinator, all with the Innovative Medicines Accelerator (IMA) at Stanford University.
Photo: Stanford research complex housing the Innovative Medicines Accelerator with Sarafan ChEM-H and the Wu Tsai Neurosciences Institute. Photo by Bruce Damonte.
Are you being evaluated for celiac disease? Do have a family member with celiac disease? Have you received an inconclusive celiac test result?
Current celiac testing can require patients to eat gluten even after adopting a gluten-free diet, which many people find difficult or physically intolerable. Stanford researchers are launching a second clinical trial of HB-2121, a new diagnostic agent being studied for its potential to diagnose celiac disease without a gluten challenge and monitor disease activity in diagnosed patients. Researchers are currently looking for volunteers to help make it possible. People currently being evaluated for celiac disease, those with a first-degree relative with celiac disease, or those who have received inconclusive test results may qualify for the clinical trial.
What is HB-2121, and why does it matter?
HB-2121 is a new investigational drug developed at Stanford. Harrison Besser, an MD/PhD student studying in the lab of Chaitan Khosla, PhD, developed the molecule during his PhD thesis. The Stanford Innovative Medicines Accelerator continued development of HB-2121 to enable the studies in people. The investigators successfully tested HB-2121 in 21 participants and no safety concerns were identified. Together, the first and second HB-2121 human trials could pave the way for simpler, more accurate testing and monitoring. Read more about HB-2121 and the previous clinical trial here.
How the clinical trial works
This Phase 1b clinical trial is the second trial testing HB-2121 in people. The trial aims to enroll 20 adults who are undergoing an endoscopy for suspected celiac disease.
After providing informed consent and passing eligibility screening, participants will drink a single dose of HB-2121 dissolved in water. Participants will be monitored for at least six hours, with their endoscopy performed four hours after drinking HB-2121.
Follow-up visits will be scheduled for the next morning and one week later, each lasting approximately one hour. Additionally, telehealth visits will occur 15 and 30 days after receiving the dose, with laboratory tests conducted at locations convenient for the participants. For seven days after the dose, participants will complete a brief daily symptom questionnaire.
The screening and follow-up visits will take place at Stanford’s Clinical and Translational Research Unit (CTRU), located at 800 Welch Road, Palo Alto, CA 94304. Participants will receive HB-2121 and their scheduled endoscopy at Stanford’s Redwood City campus, located at 420 Broadway, Redwood City, CA, 94063.
All participants who complete the study will receive up to $400 in gift cards as appreciation for their time.
Who is running the clinical trial?
The first clinical trial testing HB-2121 in humans was led by Dr. Nielsen Fernandez-Becker, Director of the Celiac Disease Program at Stanford Health Care and Dr. Nasim Khavari. It evaluated the safety of HB-2121 in people without celiac disease and people with biopsy-confirmed celiac disease. Building on that initial safety study, Drs. Fernandez-Becker and Khavari, along with colleagues Dr. Aaron Yeoh and Dr. Jeanne Shen, are conducting the second clinical trial, testing HB-2121 in people who are being evaluated for celiac disease by endoscopy.
Will my insurance cover this?
The endoscopy must be billed to and covered by your own insurance as a standard-of-care procedure. You do not need to be an existing Stanford patient — your own physician can refer you to Stanford for the endoscopy. We are happy to help navigate the referral and insurance. If you are a Kaiser Permanente member and do not have a second plan, you are likely not eligible to participate, as Kaiser generally does not cover procedures performed at outside facilities. Please reach out if you’re unsure about your plan or have more than one insurance plan.
Learn more
If you’d like to learn more about the clinical trial and consider participating, please contact Joaquin Tabera at (650) 334-1308 or jtabera7@stanford.edu. The study team looks forward to receiving your inquiry. Please don’t hesitate to reach out, as the team is happy to answer your questions.
View details of the HB-2121 clinical trial on the Studypage and ClinicalTrials.gov (NCT07377565).
If you are a Bay Area physician interested in referring patients to the study, please contact Dr. Nielsen Fernandez-Becker at 650-723-3554.
For complaints, concerns, or participant’s rights questions, contact the Stanford Institutional Review Board at 1-866-680-2906.
The Celiac Community Foundation of Northern California is providing recruitment assistance for this clinical trial as a pro bono public service to advance research that may benefit the celiac community. We have no financial relationship with the study.
