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| ID | Type | Description | Link |
|---|---|---|---|
| ACT18113 | Other Identifier | Sanofi Identifier |
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Termination for Strategic Reasons
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The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid treatment.
This was a randomized, double-blind, placebo-controlled study in adult participants with active SLE. Approximately 100 eligible participants were randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo.
Eligible participants included male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months.
The study drug was administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRV-3279 | Experimental | Sterile solution for intravenous administration, every 4 weeks |
|
| Placebo | Experimental | Sterile solution for intravenous administration, every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRV-3279 | Biological | Bi-specific antibody-based molecule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24 | Improvement in SLE disease activity:no lupus flare during baseline to Week 24. Lupus flare:Investigator's assessment that SLE activity met Lupus Foundation of America international consensus definition for flare (defined as measurable increase in disease activity in 1 or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements,must be considered clinically significant by the assessor,and usually there would be at least consideration of a change or an increase in treatment);a score of "definite worsening" or "severe worsening" on Clinician's Global Impression of Change;and at least 1 of following occurrences: an increase of >=4 points from baseline in hybrid Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (hSLEDAI),or >=1 organ with an A score (severe) or B score (moderate) item rated new or worse on British Isles Lupus Assessment Group (BILAG) Index. | Baseline (Day 1) to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure From Baseline to Week 24 | Treatment failure was defined compared to baseline as the occurrence of an SLE flare (as defined in the primary outcome measure #1); or missing 2 consecutive doses or 3 or more total doses of the study treatment for any reason; or initiation of a new SLE medication; or increased dose of current SLE medication, with the exception of nonsteroidal anti-inflammatory drugs; or participant withdrawal from the study before the Week 24 visit. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Estimations were based on the Kaplan-Meier method. |
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Inclusion Criteria:
A diagnosis of SLE for at least 6 months prior to the Screening visit
Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
Have moderate to severe disease activity despite stable standard-of-care medication defined as:
At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medvin Clinical Research - Apple Valley- Site Number : 133 | Apple Valley | California | 92307 | United States | ||
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 28 participants were randomized in a 1:1 ratio to receive either PRV-3279 10 milligram per kilogram (mg/kg) or placebo. Randomization was stratified by the presence or absence of serum anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies and the presence or absence of elevated B cell gene signature as defined by B cell pathway expression pathway testing.
The study was conducted at 36 centers in 3 countries. A total of 68 participants were screened from 20 January 2022 to 25 August 2023, of which 40 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria. The study was terminated early due to strategic reasons with no safety concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRV-3279 10 mg/kg | Participants received PRV-3279 10 mg/kg intravenous (IV) infusion over 2 hours, once every 4 weeks from Week 0 through Week 20, inclusive, for a total of 6 doses. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 16, 2022 | Mar 16, 2026 |
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| Placebo | Other | Placebo |
|
| Baseline (Day 1) to Week 24 |
| Percentage of Participants Who Met European League Against Rheumatism (EULAR)-Recommended Goal of Low Disease Responders From Baseline Until Week 24 | EULAR recommended goal of low disease responders were defined as participants who met either of following criteria: hSLEDAI score <3 (lower disease activity) or all BILAG scores were C (mild disease activity), or D (no disease activity in an organ previously affected) or E (organ inactive and never previously active). Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
| Change From Screening Until Week 24 in the Physical Component Score (PCS) in the Short Form 36 (SF-36) Health Survey | SF-36 health survey consisted of 36 items which measured 8 subscales relevant to quality of life (QOL):physical functioning(PF),general health(GH),mental health(MH),vitality(VT),role physical(RP),role emotional(RE),bodily pain(BP), and social functioning(SF).Score range for each of 8 subscales was from 0(maximum disability) to 100(no disability);higher scores indicated good health condition. Responses on SF-36 were used to calculate 2 summary scores: PCS contributed by PF,RP,BP and GH and mental component summary(MCS) contributed by MH,RE, SF and VT. Summations of item scores of same domain gave sub-scale scores, which were transformed to calculate summary scores of PCS and MCS. Both PCS and MCS score ranges from 0(worst) to 100(best); higher scores indicated less disability and better QoL. Change from screening (post-screening value minus screening value) until Week 24 in PCS in SF-36 health survey is presented. Baseline:last non-missing value prior to first dose of study treatment. | Screening (Days -42 to -1), Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants Who Met the Criteria for Systemic Lupus Erythematosus Responder Index-4 (SRI-4) From Baseline Until Week 24 | SRI-4 was defined as a hSLEDAI score decrease of >=4 points; and no new organs with a BILAG A (severe) score; and no more than 1 new organ with a BILAG B (moderate) score; and no SELENA-SLEDAI physician's global assessment (ssPGA) score increase of >0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants Who Met the British Isles Lupus Assessment Group-Based Combined Lupus Assessment (BICLA) Criteria From Baseline Until Week 24 | BICLA criteria was defined as reduction by >=1 grade in all organs with BILAG A (severe) or B (moderate) scores; and no worsening of SLEDAI or other BILAG organs; and no ssPGA score increase of >=0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs Leading to Treatment Discontinuation and Treatment-Emergent Adverse Events of Special Interest (TEAESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or any other medically important event. A TEAE was defined as an AE that developed, worsened or became serious during the TE period. An AESI was defined as a TEAE including SAE, that were of scientific and medical concern specific to PRV-3279, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was considered appropriate. | From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks |
| Serum Concentrations of PRV-3279 | Serum samples were collected at specified timepoints to evaluate serum concentration of PRV-3279. | Pre-dose and 2 hours post-dose on Days 1, 29, 57, 86, 113, 141, 169 and 197; 24, 48, 72, 168, 336 hours post-dose on Days 1 and 141 |
| Number of Participants With Anti-Drug Antibodies (ADAs) Against PRV-3279 | Blood samples were collected at specified timepoints to evaluate the presence of ADA against PRV-3279. Treatment-emergent ADA was defined as at least 1 treatment-induced or treatment-boosted ADA at any time after first study treatment administration. Treatment-induced ADA was defined as ADA that developed at any time after first study treatment administration and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented. | From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks |
| Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106 |
| Covina |
| California |
| 91722 |
| United States |
| University of California San Diego - La Jolla- Site Number : 108 | La Jolla | California | 92037 | United States |
| University of California Los Angeles Medical Center- Site Number : 122 | Los Angeles | California | 90095 | United States |
| Facey Medical Group - Los Angeles- Site Number : 126 | Los Angeles | California | 91345 | United States |
| Desert Medical Advances- Site Number : 114 | Rancho Mirage | California | 92270 | United States |
| Medvin Clinical Research - Tujunga- Site Number : 119 | Tujunga | California | 91042 | United States |
| Medvin Clinical Research - Whittier- Site Number : 118 | Whittier | California | 90602 | United States |
| Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116 | Avon Park | Florida | 33825 | United States |
| Center for Rheumatology, Immunology and Arthritis- Site Number : 109 | Fort Lauderdale | Florida | 33309 | United States |
| Millennium Research- Site Number : 111 | Ormond Beach | Florida | 32174 | United States |
| D&H Tamarac Research Center- Site Number : 123 | Tamarac | Florida | 33321 | United States |
| Florida Hospital Tampa- Site Number : 107 | Tampa | Florida | 33613 | United States |
| Vernon Hills Medical Associates- Site Number : 128 | Vernon Hills | Illinois | 60061 | United States |
| Ochsner Medical Center - Jefferson Highway- Site Number : 113 | New Orleans | Louisiana | 70121 | United States |
| Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124 | Troy | Michigan | 48084 | United States |
| University of Toledo Medical Center- Site Number : 110 | Toledo | Ohio | 43614 | United States |
| Yale University School of Medicine- Site Number : 125 | Pittsburgh | Pennsylvania | 15213-2536 | United States |
| Grapevine Rheumatology Clinic- Site Number : 103 | Grapevine | Texas | 76051 | United States |
| Accurate Clinical Management - Greenhouse Road- Site Number : 104 | Houston | Texas | 77084 | United States |
| Accurate Clinical Research - Houston Resource Parkway- Site Number : 105 | Houston | Texas | 77089 | United States |
| Sun Research Institute- Site Number : 121 | San Antonio | Texas | 78215 | United States |
| Investigational Site Number : 310 | Beijing | 100050 | China |
| Investigational Site Number : 301 | Beijing | 100730 | China |
| Investigational Site Number : 309 | Changchun | 130021 | China |
| Investigational Site Number : 302 | Guangzhou | 510080 | China |
| Investigational Site Number : 303 | Nanchang | 330006 | China |
| Investigational Site Number : 307 | Nanjing | 210008 | China |
| Investigational Site Number : 306 | Shanghai | 200127 | China |
| Investigational Site Number : 305 | Tianjin | 300052 | China |
| Investigational Site Number : 304 | Wuhan | 430030 | China |
| Investigational Site Number : 202 | Pok Fu Lam | 999077 | Hong Kong |
| Investigational Site Number : 201 | Tuenmen | 999077 | Hong Kong |
| Centro Reumatologico de Caguas- Site Number : 112 | Caguas | 00725 | Puerto Rico |
| Private Practice - Dr. Karina Vila Rivera- Site Number : 117 | San Juan | 00917 | Puerto Rico |
| BCR Medical Center Inc.- Site Number : 129 | San Juan | 909 | Puerto Rico |
Participants received placebo (0.9% sodium chloride) IV infusion over 2 hours, once every 4 weeks, from Week 0 through Week 20, inclusive, for a total of 6 doses.
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | PRV-3279 10 mg/kg | Participants received PRV-3279 10 mg/kg IV infusion over 2 hours, once every 4 weeks from Week 0 through Week 20, inclusive, for a total of 6 doses. |
| BG001 | Placebo | Participants received placebo (0.9% sodium chloride) IV infusion over 2 hours, once every 4 weeks, from Week 0 through Week 20, inclusive, for a total of 6 doses. |
| BG002 | 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Anti-dsDNA antibodies per Interactive Web Response System (IWRS) | Count of Participants | Participants |
| ||||||||||||||||
| B cell gene signature per IWRS | 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 | Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24 | Improvement in SLE disease activity:no lupus flare during baseline to Week 24. Lupus flare:Investigator's assessment that SLE activity met Lupus Foundation of America international consensus definition for flare (defined as measurable increase in disease activity in 1 or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements,must be considered clinically significant by the assessor,and usually there would be at least consideration of a change or an increase in treatment);a score of "definite worsening" or "severe worsening" on Clinician's Global Impression of Change;and at least 1 of following occurrences: an increase of >=4 points from baseline in hybrid Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (hSLEDAI),or >=1 organ with an A score (severe) or B score (moderate) item rated new or worse on British Isles Lupus Assessment Group (BILAG) Index. | FAS included all randomized participants who received at least 1 dose of study treatment. Baseline was defined as the last non-missing value prior to the first dose of study treatment. | Posted | Number | 80% Confidence Interval | percentage of participants | Baseline (Day 1) to Week 24 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure From Baseline to Week 24 | Treatment failure was defined compared to baseline as the occurrence of an SLE flare (as defined in the primary outcome measure #1); or missing 2 consecutive doses or 3 or more total doses of the study treatment for any reason; or initiation of a new SLE medication; or increased dose of current SLE medication, with the exception of nonsteroidal anti-inflammatory drugs; or participant withdrawal from the study before the Week 24 visit. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Estimations were based on the Kaplan-Meier method. | FAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | months | Baseline (Day 1) to Week 24 |
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| Secondary | Percentage of Participants Who Met European League Against Rheumatism (EULAR)-Recommended Goal of Low Disease Responders From Baseline Until Week 24 | EULAR recommended goal of low disease responders were defined as participants who met either of following criteria: hSLEDAI score <3 (lower disease activity) or all BILAG scores were C (mild disease activity), or D (no disease activity in an organ previously affected) or E (organ inactive and never previously active). Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | FAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
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| Secondary | Change From Screening Until Week 24 in the Physical Component Score (PCS) in the Short Form 36 (SF-36) Health Survey | SF-36 health survey consisted of 36 items which measured 8 subscales relevant to quality of life (QOL):physical functioning(PF),general health(GH),mental health(MH),vitality(VT),role physical(RP),role emotional(RE),bodily pain(BP), and social functioning(SF).Score range for each of 8 subscales was from 0(maximum disability) to 100(no disability);higher scores indicated good health condition. Responses on SF-36 were used to calculate 2 summary scores: PCS contributed by PF,RP,BP and GH and mental component summary(MCS) contributed by MH,RE, SF and VT. Summations of item scores of same domain gave sub-scale scores, which were transformed to calculate summary scores of PCS and MCS. Both PCS and MCS score ranges from 0(worst) to 100(best); higher scores indicated less disability and better QoL. Change from screening (post-screening value minus screening value) until Week 24 in PCS in SF-36 health survey is presented. Baseline:last non-missing value prior to first dose of study treatment. | FAS included all randomized participants who received at least 1 dose of study treatment. During the study, participants missed few scheduled site visits for data collection and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | score on a scale | Screening (Days -42 to -1), Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percentage of Participants Who Met the Criteria for Systemic Lupus Erythematosus Responder Index-4 (SRI-4) From Baseline Until Week 24 | SRI-4 was defined as a hSLEDAI score decrease of >=4 points; and no new organs with a BILAG A (severe) score; and no more than 1 new organ with a BILAG B (moderate) score; and no SELENA-SLEDAI physician's global assessment (ssPGA) score increase of >0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | FAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percentage of Participants Who Met the British Isles Lupus Assessment Group-Based Combined Lupus Assessment (BICLA) Criteria From Baseline Until Week 24 | BICLA criteria was defined as reduction by >=1 grade in all organs with BILAG A (severe) or B (moderate) scores; and no worsening of SLEDAI or other BILAG organs; and no ssPGA score increase of >=0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place. | FAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs Leading to Treatment Discontinuation and Treatment-Emergent Adverse Events of Special Interest (TEAESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or any other medically important event. A TEAE was defined as an AE that developed, worsened or became serious during the TE period. An AESI was defined as a TEAE including SAE, that were of scientific and medical concern specific to PRV-3279, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was considered appropriate. | Safety analysis set (SAF) included all participants who took at least 1 dose of the study treatment post-randomization. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks |
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| Secondary | Serum Concentrations of PRV-3279 | Serum samples were collected at specified timepoints to evaluate serum concentration of PRV-3279. | Pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of the study treatment and had at least 1 post-dose evaluable PK assessment. During the study, participants missed few scheduled site visits for sample collection and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose and 2 hours post-dose on Days 1, 29, 57, 86, 113, 141, 169 and 197; 24, 48, 72, 168, 336 hours post-dose on Days 1 and 141 |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) Against PRV-3279 | Blood samples were collected at specified timepoints to evaluate the presence of ADA against PRV-3279. Treatment-emergent ADA was defined as at least 1 treatment-induced or treatment-boosted ADA at any time after first study treatment administration. Treatment-induced ADA was defined as ADA that developed at any time after first study treatment administration and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented. | Immunogenicity (IMG) analysis set included all randomized participants who received at least 1 dose of the study treatment and had at least 1 post-dose evaluable IMG assessment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks |
|
|
Adverse events were collected from first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks. All-cause mortality (deaths) were collected from screening (Days -42 to 1) up to end of follow-up, approximately 126.5 weeks.
Analysis was performed on the SAF.
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 | PRV-3279 10 mg/kg | Participants received PRV-3279 10 mg/kg IV infusion over 2 hours, once every 4 weeks from Week 0 through Week 20, inclusive, for a total of 6 doses. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG001 | Placebo | Participants received placebo (0.9% sodium chloride) IV infusion over 2 hours, once every 4 weeks, from Week 0 through Week 20, inclusive, for a total of 6 doses. | 0 | 14 | 0 | 14 | 7 | 14 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
The study was terminated early due to strategic reasons with no safety concerns.
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 ext 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2025 | Mar 16, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Presence |
|
| High |
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Placebo | Participants received placebo (0.9% sodium chloride) IV infusion over 2 hours, once every 4 weeks, from Week 0 through Week 20, inclusive, for a total of 6 doses. |
|
|
| Participants |
|
|
|
|
Participants received placebo (0.9% sodium chloride) IV infusion over 2 hours, once every 4 weeks, from Week 0 through Week 20, inclusive, for a total of 6 doses. |
|
|
|
|