Clinical trial NCT04424927: PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire
timeFrame: 24 weeks
Secondary outcomes:
measure: Effect of treatment with PRV-015 on other measures of disease activity
timeFrame: 24 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 28 weeks
measure: Serum trough concentrations of PRV-015 at scheduled visits
timeFrame: 28 weeks
measure: Incidence of anti-PRV-015 antibodies
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Site
state: California
city: Ventura
country: United States
facility: Clinical Site
state: California
city: Denver
country: United States
facility: Clinical Site
state: Colorado
city: Leesburg
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Winter Park
country: United States
facility: Clinical Site
state: Florida
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Northbrook
country: United States
facility: Clinical Trial Site
state: Illinois
city: Chevy Chase
country: United States
facility: Clinical Trial Site
state: Maryland
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Site
state: Michigan
city: Rochester
country: United States
facility: Clinical Site
state: Minnesota
city: Morristown
country: United States
facility: Clinical Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Trial Site
state: New York
city: New Windsor
country: United States
facility: Clinical Site
state: New York
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Raleigh
country: United States
facility: Clinical Site
state: North Carolina
city: Dublin
country: United States
facility: Clinical Trial Site
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Clinical Site
state: Pennsylvania
city: Warwick
country: United States
facility: Clinical Site
state: Rhode Island
city: North Charleston
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Cedar Park
country: United States
facility: Clinical Trial Site
state: Texas
city: Garland
country: United States
facility: Clinical Site
state: Texas
city: West Jordan
country: United States
facility: Clinical Site
state: Utah
city: Bellevue
country: United States
facility: Clinical Site
state: Washington
city: Tacoma
country: United States
facility: Clinical Site
state: Washington
city: Hamilton
country: Canada
facility: Clinical Site
state: Ontario
city: Amsterdam
country: Netherlands
facility: Clinical Site
city: Seville
country: Spain
facility: Clinical Site
state: Andalusia
city: Leon
country: Spain
facility: Clinical Site
state: Castilla Y Leon
city: Terrassa
country: Spain
facility: Clinical Trial Site
state: Catalunya
city: Girona
country: Spain
facility: Clinical Trial Site
city: Lleida
country: Spain
facility: Clinical Trial Site
city: Madrid
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: