NCT04524221

PTG-100 for Patients With Celiac Disease

Completed Phase 1 Last updated 23 May 2022

What this trial tests

Phase 1 trial testing PTG-100 in Celiac Disease in 12 participants. Completed in 3 April 2022.

Timeline

26 February 2021

Primary endpoint
3 April 2022

3 April 2022

Quick facts

Lead sponsor	Nielsen Fernandez-Becker
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	26 February 2021
Primary completion	3 April 2022
Estimated completion	3 April 2022
Sites	1 location across United States

Drugs / interventions tested

• PTG-100 — full drug profile →
• Placebo

Conditions studied

• Celiac Disease — all drugs for Celiac Disease →

Sponsor

Nielsen Fernandez-Becker — full company profile →

Who can join

Adults 18 to 80, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.

This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gliadin Sequestration as a Novel Therapy for Celiac Disease: A Prospective Application for Polyphenols.
   Van Buiten CB, Elias RJ. · · 2021 · cited 14× · PMID 33435615 · DOI 10.3390/ijms22020595
2. Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
   Girbal-González M, Pérez-Cano FJ. · · 2025 · cited 2× · PMID 41010485 · DOI 10.3390/nu17182960
3. From an understanding of etiopathogenesis to novel therapies-what is new in the treatment of celiac disease?
   Skoracka K, Hryhorowicz S, Tovoli F, Raiteri A, et al · · 2024 · cited 2× · PMID 38698821 · DOI 10.3389/fphar.2024.1378172
4. Upcoming Treatments in Celiac Disease: From Luminal Enzymes to Oral Immune Tolerance.
   Taavela J, Elli L, Bouma G, Tye-Din JA, et al · · 2026 · PMID 42033586 · DOI 10.1002/ueg2.70222
5. Rethinking Celiac Disease Management: Treatment Approaches Beyond the Gluten-Free Diet.
   Kounatidis D, Pavlou A, Evangelopoulos A, Psaroudaki M, et al · · 2025 · PMID 41595566 · DOI 10.3390/biomedicines14010029