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

P

Provention Bio, a Sanofi Company

Status and phase

Active, not recruiting
Phase 2

Conditions

Celiac Disease

Treatments

Other: Placebo
Biological: PRV-015

Study type

Interventional

Funder types

Industry

Identifiers

NCT04424927
PRV-015-002b

Details and patient eligibility

About

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).

Full 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.

Enrollment

226 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

226 participants in 4 patient groups, including a placebo group

PRV-015 Low Dose
Experimental group
Description:
PRV-015 Low Dose, sterile solution for subcutaneous administration
Treatment:
Biological: PRV-015
PRV-015 Medium Dose
Experimental group
Description:
PRV-015 Medium Dose, sterile solution for subcutaneous administration
Treatment:
Biological: PRV-015
PRV-015 High Dose
Experimental group
Description:
PRV-015 High Dose, sterile solution for subcutaneous administration
Treatment:
Biological: PRV-015
Placebo
Placebo Comparator group
Description:
Placebo, sterile solution for subcutaneous administration
Treatment:
Other: Placebo

Trial contacts and locations

38

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Central trial contact

Proactive Trial Transparency; Study Director

Data sourced from clinicaltrials.gov

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