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| ID | Type | Description | Link |
|---|---|---|---|
| DRI18114 | Other Identifier | Sanofi Identifier | |
| 2020-000649-16 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRV-015 Low Dose | Experimental | PRV-015 Low Dose, sterile solution for subcutaneous administration |
|
| PRV-015 Medium Dose | Experimental | PRV-015 Medium Dose, sterile solution for subcutaneous administration |
|
| PRV-015 High Dose | Experimental | PRV-015 High Dose, sterile solution for subcutaneous administration |
|
| Placebo | Placebo Comparator | Placebo, sterile solution for subcutaneous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRV-015 | Biological | Fully human monoclonal antibody against interleukin 15 (IL-15) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (average of Day -7 to Day -1) up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Los Angeles | California | 90036 | United States | ||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41039829 | Derived | 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. |
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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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A total of 388 participants entered the single-blind placebo run-in period and among them, 1 participant never received treatment and was not started after signing the ICF, 9 participants discontinued during run-in or were not dosed, and 27 participants were considered run-in failures. Another 126 participants were considered randomization failures. A total of 226 participants were enrolled and randomized in the study.
The study was conducted at 39 centers in 4 countries. A total of 648 participants were screened between 24 August 2020 and 16 January 2024, of which 255 participants were screen failures and 5 participants discontinued before run-in period. Screen failures were mainly due to not meeting eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-blind: Placebo | Participants received placebo subcutaneous (SC) injection every 2 weeks (q2w) in single-blind placebo run-in period for 4 weeks. |
| FG001 | Double-blind: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single-blind Period (4 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2022 | Jul 24, 2025 |
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| Placebo | Other | Placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28 |
| Ventura |
| California |
| 93003 |
| United States |
| Clinical Site | Denver | Colorado | 80209 | United States |
| Clinical Site | Leesburg | Florida | 34748 | United States |
| Clinical Site | Tampa | Florida | 33613 | United States |
| Clinical Site | Winter Park | Florida | 32789 | United States |
| Clinical Site | Chicago | Illinois | 60637 | United States |
| Clinical Trial Site | Northbrook | Illinois | 60062 | United States |
| Clinical Trial Site | Chevy Chase | Maryland | 20815 | United States |
| Clinical Site | Boston | Massachusetts | 02111 | United States |
| Clinical Site | Chesterfield | Michigan | 48047 | United States |
| Clinical Site | Rochester | Minnesota | 55905 | United States |
| Clinical Site | Morristown | New Jersey | 07960 | United States |
| Clinical Trial Site | Brooklyn | New York | 11235 | United States |
| Clinical Site | New Windsor | New York | 12553 | United States |
| Clinical Trial Site | New York | New York | 10032 | United States |
| Clinical Site | Raleigh | North Carolina | 27607 | United States |
| Clinical Trial Site | Dublin | Ohio | 43016 | United States |
| Clinical Site | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Site | Uniontown | Pennsylvania | 14401 | United States |
| Clinical Site | Warwick | Rhode Island | 02886 | United States |
| Clinical Trial Site | North Charleston | South Carolina | 29405 | United States |
| Clinical Site | Nashville | Tennessee | 37212 | United States |
| Clinical Trial Site | Cedar Park | Texas | 78613 | United States |
| Clinical Site | Garland | Texas | 75044 | United States |
| Clinical Site | West Jordan | Utah | 84088 | United States |
| Clinical Site | Bellevue | Washington | 98004 | United States |
| Clinical Site | Tacoma | Washington | 98405 | United States |
| Clinical Site | Hamilton | Ontario | L8S4K1 | Canada |
| Clinical Site | Amsterdam | 1105 AZ | Netherlands |
| Clinical Site | Seville | Andalusia | 41013 | Spain |
| Clinical Site | León | Castille and León | 24071 | Spain |
| Clinical Trial Site | Terrassa | Catalonia | 082211 | Spain |
| Clinical Trial Site | Girona | 17007 | Spain |
| Clinical Trial Site | Lleida | 25196 | Spain |
| Clinical Site | Madrid | 28034 | Spain |
| Clinical Site | Madrid | 28041 | Spain |
| Clinical Site | Madrid | 28222 | Spain |
Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.
| FG002 | Double-blind: PRV-015 100 mg | Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks. |
| FG003 | Double-blind: PRV-015 300 mg | Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| FG004 | Double-blind: PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Period (24 Weeks) |
|
|
Single-blind period: Participants treated with single-blind placebo in run-in period are included.
Double-blind period: The intent-to-treat analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-blind: Placebo | Participants received placebo SC injection q2w in single-blind placebo run-in period for 4 weeks. |
| BG001 | Double-blind: Placebo | Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks. |
| BG002 | Double-blind: PRV-015 100 mg | Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| BG003 | Double-blind: PRV-015 300 mg | Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| BG004 | Double-blind: PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline measure data reported for each study period separately. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Baseline measure data reported for each study period separately. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Baseline measure data reported for each study period separately. | Count of Participants | Participants |
| ||||||||||
| Celiac Disease Patient Reported Outcome (CeD PRO) Abdominal Symptoms Domain Score | The CeD PRO questionnaire was captured daily in the electronic (e)Diary. 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 measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0. | Count of Participants | Participants |
| |||||||||
| Number of Participants for Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD) | Esophagogastroduodenoscopy and biopsy were performed to determine villus height and crypt depth and their ratio. | Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (average of Day -7 to Day -1) up to Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (average of Day -7 to Day -1) up to Week 24 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (average of Day -7 to Day -1) up to Week 24 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | cells/100 epithelial cells | Baseline to Week 24 |
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| 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) | 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. | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Posted | Count of Participants | Participants | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days |
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| Secondary | 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. | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Posted | Count of Participants | Participants | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days |
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| Secondary | Number of Participants With Anti-PRV-015 Antibodies | Blood samples were collected to determine the presence of anti-drug antibodies by immunoassay. | 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. | Posted | Count of Participants | Participants | Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28 |
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| Secondary | Minimum Serum Concentrations (Cmin) of PRV-015 | Blood samples were collected at specified timepoints to determine the Cmin. | The Pharmacokinetic (PK) analysis set included participants who were randomized, dosed, and had at least 1 post-dose evaluable PK assessment. Only participants with data collected at specific time point are reported. Participants were not analyzed at pre-dose on Day 1 as the study drug was not administered. Hence, no data collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28 |
|
Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-blind: Placebo | Participants received placebo SC injection q2w in single-blind placebo run-in period for 4 weeks. | 0 | 387 | 2 | 387 | 0 | 387 |
| EG001 | Double-blind: Placebo | Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks. | 0 | 57 | 1 | 57 | 22 | 57 |
| EG002 | Double-blind: PRV-015 100 mg | Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks. | 0 | 56 | 0 | 56 | 18 | 56 |
| EG003 | Double-blind: PRV-015 300 mg | Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. | 0 | 57 | 0 | 57 | 22 | 57 |
| EG004 | Double-blind: PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. | 0 | 54 | 1 | 54 | 19 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presyncope | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Gluten Sensitivity | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDra 27.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2024 | Jul 24, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Investigator or Sponsor judgement |
|
| Other |
|
|
| Double-blind period |
|
|
|
| Double-blind period |
|
|
|
| Double-blind period |
|
|
|
| Double-blind period |
|
|
|
| Double-blind period |
|
|
Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect. |
| MMRM |
| 0.6552 |
| LS mean difference |
| 0.11 |
| 2-Sided |
| 95 |
| -0.37 |
| 0.59 |
| Other |
| Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect. | MMRM | 0.8705 | LS mean difference | 0.04 | 2-Sided | 95 | -0.45 | 0.53 | Other |
| OG002 | PRV-015 300 mg | Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| OG003 | PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
|
| OG002 |
| PRV-015 300 mg |
Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| OG003 | PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
|
Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
|
| OG002 | PRV-015 300 mg | Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks. |
| OG003 | PRV-015 600 mg | Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
|
|
Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
| PRV-015 600 mg |
Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks. |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Male |
|
| White |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Not Reported |
|
| Unknown |
|
| Multiple |
|
| Score: >=3 |
|
| Ratio: >=2 |
|
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