The Proactive Celiac Study

Recruiting
18 years - 69 years
All
Phase 2
10 participants needed
1 Location

Brief description of study

Are you still experiencing celiac disease symptoms despite your best efforts to follow a gluten-free diet?
The goal of this phase 2 clinical trial is to test the safety and effects of the investigational medication PRV-015. In combination with a gluten-free diet, PRV-015 aims to reduce symptoms and intestinal inflammation caused by accidental gluten exposure.

What to expect with participation in this study?
If you qualify and choose to take part in this study, your participation will last about 9 months. You will continue to follow your usual gluten-free diet throughout the entire study. If you change your mind about participating, you can choose to leave the study at any time for any reason

Detailed description of study

Screening Period
(up to 28 days):
During the screening period, the study doctor will confirm your eligibility to participate in the study with a full physical exam, including your medical history and laboratory tests from blood and urine samples.

Treatment Period
(about 28 weeks):
During the treatment period, you will come to the clinic to receive the study drug or placebo at each visit. The study doctor will monitor your health by performing physical exams and collecting blood, urine, and stool samples. You will have one endoscopy with biopsy at the beginning of the study and one at the end. You will also be given an electronic diary, similar to a smart phone, to track your symptoms throughout the study.

Follow-up Period
(about 4 weeks):
During the follow-up period, you will continue to complete the symptom diary and return to the clinic for one more visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: celiac disease
  • Age: 18 years - 69 years
  • Gender: All

  • Biopsy-confirmed celiac disease
  • On a gluten-free diet for at least the last 12 months
  • Still experiencing celiac disease symptoms

Updated on 04 Aug 2024. Study ID: 8437799

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