PTG-100 for Patients With Celiac Disease

Nielsen Fernandez-Becker

Status and phase: Completed; Phase 1

Conditions: Celiac Disease

Treatments: Drug: Placebo; Drug: PTG-100

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04524221

57613

PTG-100-05-CeD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of celiac disease

Exclusion criteria

• Active GI disease or history of clinically significant diseases
• Diagnosis of Crohn's disease or ulcerative colitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

PTG-100

Experimental group

Description:

Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.

Treatment:

Drug: PTG-100

Placebo

Placebo Comparator group

Description:

Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.

Treatment:

Drug: Placebo