Trial · NCT04424927
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
NCT04424927, Phase 2, Completed, Provention Bio, a Sanofi Company; results first posted 2025-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PRV-015 in Gluten-free Diet Non-responsive Celiac Disease. Trials, record NCT04424927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04424927
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
- NCT number
- NCT04424927
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 388 participants, actual
- Lead sponsor
- Provention Bio, a Sanofi Company
- Conditions
- Celiac Disease
- Interventions
- PRV-015, Placebo
- First posted
- 2020-06-11
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2020-000649-16
- Results first posted
- 2025-10-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | 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 | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | 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. |
| Secondary | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 | 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. |
| Secondary | Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24 | 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) | 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. |
| Secondary | Number of Participants With Potentially Clinically Important Changes in Hematology | 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. |
| Secondary | Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry | 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. |
| Secondary | Number of Participants With Potentially Clinically Important Changes in Urinalysis | 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. |
| Secondary | Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight | 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. |
| Secondary | Number of Participants With Anti-PRV-015 Antibodies | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24 | Baseline to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and Week 24 are reported. | cells/100 epithelial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Hematology | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Urinalysis | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected for each specific parameter are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-PRV-015 Antibodies | Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28 | The Immunogenicity analysis set included participants who were randomized, dosed, and had at least 1 evaluable immunogenicity assessment. Only participants with data collected at specific time point are reported. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group183
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | Placebo | -1.32 | 95% Confidence Interval -1.66 to -0.98 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | PRV-015 100 mg | -1.28 | 95% Confidence Interval -1.62 to -0.94 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | PRV-015 300 mg | -1.21 | 95% Confidence Interval -1.55 to -0.88 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | PRV-015 600 mg | -1.28 | 95% Confidence Interval -1.63 to -0.93 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | Placebo | -0.77 | 95% Confidence Interval -1.15 to -0.40 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | PRV-015 100 mg | -0.66 | 95% Confidence Interval -1.04 to -0.28 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | PRV-015 300 mg | -1.02 | 95% Confidence Interval -1.39 to -0.64 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | PRV-015 600 mg | -1.07 | 95% Confidence Interval -1.46 to -0.68 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 | Placebo | -0.89 | 95% Confidence Interval -1.15 to -0.63 | score on a scale | |
| Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 | PRV-015 100 mg | -0.84 | 95% Confidence Interval -1.10 to -0.57 | score on a scale |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-blind Period (4 Weeks) | STARTED | Single-blind: Placebo | 388 | |
| Single-blind Period (4 Weeks) | STARTED | Double-blind: Placebo | 0 | |
| Single-blind Period (4 Weeks) | STARTED | Double-blind: PRV-015 100 mg | 0 | |
| Single-blind Period (4 Weeks) | STARTED | Double-blind: PRV-015 300 mg | 0 | |
| Single-blind Period (4 Weeks) | STARTED | Double-blind: PRV-015 600 mg | 0 | |
| Single-blind Period (4 Weeks) | Received Treatment | Single-blind: Placebo | 387 | |
| Single-blind Period (4 Weeks) | Received Treatment | Double-blind: Placebo | 0 | |
| Single-blind Period (4 Weeks) | Received Treatment | Double-blind: PRV-015 100 mg | 0 | |
| Single-blind Period (4 Weeks) | Received Treatment | Double-blind: PRV-015 300 mg | 0 | |
| Single-blind Period (4 Weeks) | Received Treatment | Double-blind: PRV-015 600 mg | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Single-blind: Placebo | 0 | 387 | 0 |
| other | Covid-19 | Infections and infestations | Double-blind: Placebo | 3 | 57 | 3 |
| other | Covid-19 | Infections and infestations | Double-blind: PRV-015 100 mg | 5 | 56 | 5 |
| other | Covid-19 | Infections and infestations | Double-blind: PRV-015 300 mg | 8 | 57 | 8 |
| other | Covid-19 | Infections and infestations | Double-blind: PRV-015 600 mg | 5 | 54 | 5 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Single-blind: Placebo | 0 | 387 | 0 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Double-blind: Placebo | 5 | 57 | 6 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Double-blind: PRV-015 100 mg | 3 | 56 | 5 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Double-blind: PRV-015 300 mg | 4 | 57 | 4 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Double-blind: PRV-015 600 mg | 4 | 54 | 4 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single-blind: Placebo | 0 | 387 |
| Total, all-cause mortality | Double-blind: Placebo | 0 | 57 |
| Total, all-cause mortality | Double-blind: PRV-015 100 mg | 0 | 56 |
| Total, all-cause mortality | Double-blind: PRV-015 300 mg | 0 | 57 |
| Total, all-cause mortality | Double-blind: PRV-015 600 mg | 0 | 54 |
| Total, other adverse events | Single-blind: Placebo | 0 | 387 |
| Total, other adverse events | Double-blind: Placebo | 22 | 57 |
| Total, other adverse events | Double-blind: PRV-015 100 mg | 18 | 56 |
| Total, other adverse events | Double-blind: PRV-015 300 mg | 22 | 57 |
| Total, other adverse events | Double-blind: PRV-015 600 mg | 19 | 54 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41039829 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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