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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424927
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Provention Bio, a Sanofi Company )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Celiac Disease Biological: PRV-015 Other: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRV-015 Low Dose
PRV-015 Low Dose, sterile solution for subcutaneous administration
 Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Experimental: PRV-015 Medium Dose
PRV-015 Medium Dose, sterile solution for subcutaneous administration
 Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Experimental: PRV-015 High Dose
PRV-015 High Dose, sterile solution for subcutaneous administration
 Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Placebo Comparator: Placebo
Placebo, sterile solution for subcutaneous administration
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 24 weeks ]
    Celiac Disease Patient-Reported Outcome (CeD PRO)


Secondary Outcome Measures :
  1. Effect of treatment with PRV-015 on other measures of disease activity [ Time Frame: 24 weeks ]
    Intraepithelial lymphocyte (IEL) density

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 28 weeks ]
    Safety endpoint

  3. Serum trough concentrations of PRV-015 at scheduled visits [ Time Frame: 28 weeks ]
    Characterize the pharmacokinetics (PK) of PRV-015

  4. Incidence of anti-PRV-015 antibodies [ Time Frame: 28 weeks ]
    Immunogenicity endpoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424927


Locations
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Sponsors and Collaborators
Provention Bio, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Provention Bio, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04424927    
Other Study ID Numbers: PRV-015-002b
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases