Celiac DiseasePhase 2PROACTIVENCT04424927
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
A Phase 2 study testing PRV-015 in people with Celiac Disease, run by Provention Bio, a Sanofi Company at 38 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- PRV-015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 38 sitesin 4 countries
- Study dates
- 24 Aug 2020to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
United States28 sites
Clinical Site
Bellevue, Washington, 98004
Clinical Site
Boston, Massachusetts, 02111
Clinical Trial Site
Brooklyn, New York, 11235
Clinical Trial Site
Cedar Park, Texas, 78613
Clinical Site
Chesterfield, Michigan, 48047
Clinical Trial Site
Chevy Chase, Maryland, 20815
Clinical Site
Chicago, Illinois, 60637
Clinical Site
Denver, Colorado, 80209
Clinical Trial Site
Dublin, Ohio, 43016
Clinical Site
Garland, Texas, 75044
Clinical Site
Leesburg, Florida, 34748
Clinical Site
Los Angeles, California, 90036
Clinical Site
Morristown, New Jersey, 07960
Clinical Site
Nashville, Tennessee, 37212
Clinical Site
New Windsor, New York, 12553
Clinical Trial Site
New York, New York, 10032
Clinical Trial Site
North Charleston, South Carolina, 29405
Clinical Trial Site
Northbrook, Illinois, 60062
Clinical Site
Philadelphia, Pennsylvania, 19104
Clinical Site
Raleigh, North Carolina, 27607
Clinical Site
Rochester, Minnesota, 55905
Clinical Site
Tacoma, Washington, 98405
Clinical Site
Tampa, Florida, 33613
Clinical Site
Uniontown, Pennsylvania, 14401
Clinical Site
Ventura, California, 93003
Clinical Site
Warwick, Rhode Island, 02886
Clinical Site
West Jordan, Utah, 84088
Clinical Site
Winter Park, Florida, 32789
Spain8 sites
Clinical Trial Site
Girona, 17007
Clinical Site
León, Castille and León, 24071
Clinical Trial Site
Lleida, 25196
Clinical Site
Madrid, 28034
Clinical Site
Madrid, 28041
Clinical Site
Madrid, 28222
Clinical Site
Seville, Andalusia, 41013
Clinical Trial Site
Terrassa, Catalonia, 082211
About this study
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
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).
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- PRV-015, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-015Biological
Fully human monoclonal antibody against interleukin 15 (IL-15)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRV-015 Low Dose | Experimental | PRV-015 Low Dose, sterile solution for subcutaneous administration Receives: Biological: PRV-015 |
| PRV-015 Medium Dose | Experimental | PRV-015 Medium Dose, sterile solution for subcutaneous administration Receives: Biological: PRV-015 |
| PRV-015 High Dose | Experimental | PRV-015 High Dose, sterile solution for subcutaneous administration Receives: Biological: PRV-015 |
| Placebo | Placebo comparator | Placebo, sterile solution for subcutaneous administration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through 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.
Measured: Baseline (average of Day -7 to Day -1) up to Week 24
Secondary outcomes (10)
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through 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.
Measured: Baseline (average of Day -7 to Day -1) up to Week 24
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through 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.
Measured: Baseline (average of Day -7 to Day -1) up to Week 24
Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at 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.
Measured: Baseline to Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
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.
Measured: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Potentially Clinically Important Changes in Hematology
Blood samples were collected to determine the hematology laboratory important changes. CHG= Change from baseline hemoglobin.
Measured: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry
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.
Measured: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Potentially Clinically Important Changes in Urinalysis
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.
Measured: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight
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.
Measured: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
Number of Participants With Anti-PRV-015 Antibodies
Blood samples were collected to determine the presence of anti-drug antibodies by immunoassay.
Measured: Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28
Minimum Serum Concentrations (Cmin) of PRV-015
Blood samples were collected at specified timepoints to determine the Cmin.
Measured: Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start24 Aug 2020
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424927
- Sponsor's protocol ID
- PRV-015-002b
- Other IDs
- DRI18114, 2020-000649-16
- Acronym
- PROACTIVE
- Status last verified
- Oct 2025
- First submitted
- 28 May 2020
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
PubMed 41039829
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424927
- Acronym / sponsor ID
- PROACTIVE / PRV-015-002b
- Conditions
- Celiac Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Provention Bio, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRV-015 Low Dose | Experimental | Biological: PRV-015PRV-015 Low Dose, sterile solution for subcutaneous administration |
| PRV-015 Medium Dose | Experimental | Biological: PRV-015PRV-015 Medium Dose, sterile solution for subcutaneous administration |
| PRV-015 High Dose | Experimental | Biological: PRV-015PRV-015 High Dose, sterile solution for subcutaneous administration |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, sterile solution for subcutaneous administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRV-015Fully human monoclonal antibody against interleukin 15 (IL-15) | Biological | PRV-015 High Dose, PRV-015 Low Dose, PRV-015 Medium Dose |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
10 secondary outcomes
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
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
Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24
Time frame: Baseline to Week 24
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
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
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
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
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
Number of Participants With Anti-PRV-015 Antibodies
Time frame: Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41039829Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
38 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRV-015 in people with Celiac Disease, run by Provention Bio, a Sanofi Company at 38 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Spain, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.