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.
Updated on 25 May 2022
bloating
diarrhea
monoclonal antibodies
abdominal pain
gluten

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 IdentifierNCT04424927
SponsorProvention Bio, Inc.
Last Modified on25 May 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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