PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (PROACTIVE)

STATUS

Recruiting
End date

Dec 31, 2023
participants needed

220
sponsor

Provention Bio, Inc.

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Updated on 25 May 2022

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Summary

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

Description

PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD.

Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms.

Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Details

Condition	Celiac Disease
Treatment	Placebo, PRV-015
Clinical Study Identifier	NCT04424927
Sponsor	Provention Bio, Inc.
Last Modified on	25 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	A diagnosis of celiac disease by intestinal biopsy
	Following a GFD for at least 12 consecutive months
	Must have detectable (above the lower limit of detection) serum celiac-related antibodies
	Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
	Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas
	Body weight between 35 and 120 kg
Exclusion Criteria
	Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
	Diagnosis of any chronic, active GI disease other than celiac disease
	Presence of any active infection
	Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
	Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
	Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
	History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
	Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding

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PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (PROACTIVE)