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Completed

NCT Number: NCT04424927

PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

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).

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRV-015

Biological

Fully human monoclonal antibody against interleukin 15 (IL-15)

Placebo

Other

Placebo

Primary outcomes

  1. Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24

    Time frame: Baseline (average of Day -7 to Day -1) up to Week 24

    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.

Secondary outcomes

  1. Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24

    Time frame: Baseline (average of Day -7 to Day -1) up to Week 24

    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Diarrhea and loose stool domain included diarrhea and loose stool. Total score for diarrhea and loose stool domain range from 0 to 20. Higher scores indicated worse outcome. Baseline diarrhea and loose stool domain score was defined as the average of the daily scores for the last week of the placebo run-in period.

  2. Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24

    Time frame: Baseline (average of Day -7 to Day -1) up to Week 24

    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Total GI domain included abdominal symptoms domain, diarrhea, loose stool and nausea. Total GI score range from 0 to 70. Higher scores indicated worse outcome. Baseline GI score was defined as the average of the daily scores for the last week of the placebo run-in period.

  3. Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24

    Time frame: Baseline to Week 24

    The small intestinal mucosal inflammation was measured by IEL density using immunohistochemistry. Baseline was defined as IEL density from the esophagogastroduodenoscopy biopsy conducted during the run-in period.

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)

    Time frame: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs included severe opportunistic infections and hypersensitivity reactions of at least moderate severity. A TEAE was defined as an AE that occurred from the first dose of post-randomization study drug administration through the end of the study.

  5. Number of Participants With Potentially Clinically Important Changes in Hematology

    Time frame: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

    Blood samples were collected to determine the hematology laboratory important changes. CHG= Change from baseline hemoglobin.

  6. Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry

    Time frame: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

    Blood samples were collected to determine the clinical chemistry laboratory important changes. ULN= Upper limit of normal, mmol/L= millimoles per liter and mcmol/L= micromoles per liter.

  7. Number of Participants With Potentially Clinically Important Changes in Urinalysis

    Time frame: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

    Urine samples were collected to determine the important changes in urine. TNTC= Too numerous to count, LPF= Low power field and HPF= High power field.

  8. Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight

    Time frame: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

    Participant's vital signs and body weight were examined to determine the important changes. Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. mmHg= millimeters of mercury, DFB= Decrease from baseline and IFB= Increase from baseline.

  9. Number of Participants With Anti-PRV-015 Antibodies

    Time frame: Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28

    Blood samples were collected to determine the presence of anti-drug antibodies by immunoassay.

  10. Minimum Serum Concentrations (Cmin) of PRV-015

    Time frame: Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28

    Blood samples were collected at specified timepoints to determine the Cmin.

Sponsors and collaborators

Lead sponsor

Provention Bio, a Sanofi Company

Industry

Registry information

Official study 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

Acronym: PROACTIVE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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