A Phase 2 interventional study of SAR441566 and Placebo in Psoriasis, sponsored by Sanofi. Completed at 51 sites in 17 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details included a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (4 weeks ± 3 days). The total number of study visits was 7.
The overall study duration for each participant was up to 149 days.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 221 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and D1 (prior to randomization):
Exclusion Criteria:
History of diagnosis of demyelinating disease such as but not limited to:
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received dose regimen A of SAR441566
Drug: SAR441566
Participants received dose regimen B of SAR441566
Drug: SAR441566
Participants received dose regimen C of SAR441566
Drug: SAR441566
Participants received dose regimen D of SAR441566
Drug: SAR441566
Participants received dose regimen E of SAR441566
Drug: SAR441566
Participants received SAR441566 matching placebo
Drug: Placebo
Tablet
Tablet
Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
Time frame: Baseline (Day 1) and Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12
PASI is linear combination of percent of surface area of skin that is affected and severity of E, i, D over 4 body regions: h, t, u, l. The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range: 0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax": 0= no involvement,1= \<10% to 6 =90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. The PASI score ranges from 0 (no disease) to 72 (maximal disease); higher scores indicate greater psoriasis severity. Baseline was defined as last available value before the first dose of study treatment.
Time frame: Baseline (Day 1) to Week 12
Percentage of Participants With Static Psoriasis Global Assessment (sPGA) Score 0 (Complete Clearance) or 1 (Minimal Disease) at Week 12
sPGA is 5-point score based on average thickness,erythema,and scaling of all psoriatic lesions.Score ranges:E:0(normal) to 4(bright to deep red coloration of lesions); i (plaque elevation):0(none) to 4(severe thickening with hard edges; D:0(no scaling) to 3(moderate scaling).Overall scoring: average of E,i,D;range:0(clear)= 0 for all 3 symptoms; 1(almost clear)=mean \>0, \<1.5, normal to pink coloration, just detectable(possible slight elevation),no to minimal focal scaling; 2(mild)= mean \>= 1.5, \<2.5, pink to light red coloration, mild thickening, predominantly fine scaling; 3(moderate)= mean \>=2.5,\<3.5, dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling; 4(severe)= mean \>=3.5,bright to deep dark red coloration,severe thickening with hard edges,severe coarse scaling covering almost all or all lesions.Lower score:less body coverage,with 0:complete clearance and 1:minimal disease. Total participants who received score of 0 and 1 are reported.
Time frame: Baseline (Day 1) and Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether 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 or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Time frame: From first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days
Pre-Dose Plasma Concentration of SAR441566
Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.
Time frame: 1 hour pre-dose on Weeks 2, 4, 8 and 12
Post-Dose Plasma Concentration of SAR441566
Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.
Time frame: 2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12
The study was conducted at 51 centers in 17 countries. A total of 292 participants were screened from 26 October 2023 to 24 July 2024, of which 71 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
| Milestone | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Started | 35 | 47 | 24 | 46 | 45 | 24 |
| Completed | 27 | 36 | 20 | 41 | 39 | 23 |
| Not completed | 8 | 11 | 4 | 5 | 6 | 1 |
| Withdrew: Adverse event | 1 | 3 | 0 | 0 | 1 | 0 |
| Withdrew: Non-compliance with study schedule | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 4 | 3 | 5 | 3 | 1 |
| Withdrew: Other | 2 | 4 | 1 | 0 | 1 | 0 |
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
| percentage of participants | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12 | 20.0 | 44.0 | 50.0 | 58.3 | 28.0 | 33.3 |
PASI is linear combination of percent of surface area of skin that is affected and severity of E, i, D over 4 body regions: h, t, u, l. The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range: 0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax": 0= no involvement,1= \<10% to 6 =90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. The PASI score ranges from 0 (no disease) to 72 (maximal disease); higher scores indicate greater psoriasis severity. Baseline was defined as last available value before the first dose of study treatment.
| percent change | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12 | -40.65 (-52.98 to -28.33) | -63.42 (-75.73 to -51.11) | -60.56 (-73.12 to -48.01) | -65.18 (-77.74 to -52.62) | -60.84 (-73.14 to -48.54) | -65.85 (-78.40 to -53.30) |
sPGA is 5-point score based on average thickness,erythema,and scaling of all psoriatic lesions.Score ranges:E:0(normal) to 4(bright to deep red coloration of lesions); i (plaque elevation):0(none) to 4(severe thickening with hard edges; D:0(no scaling) to 3(moderate scaling).Overall scoring: average of E,i,D;range:0(clear)= 0 for all 3 symptoms; 1(almost clear)=mean \>0, \<1.5, normal to pink coloration, just detectable(possible slight elevation),no to minimal focal scaling; 2(mild)= mean \>= 1.5, \<2.5, pink to light red coloration, mild thickening, predominantly fine scaling; 3(moderate)= mean \>=2.5,\<3.5, dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling; 4(severe)= mean \>=3.5,bright to deep dark red coloration,severe thickening with hard edges,severe coarse scaling covering almost all or all lesions.Lower score:less body coverage,with 0:complete clearance and 1:minimal disease. Total participants who received score of 0 and 1 are reported.
| percentage of participants | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Percentage of Participants With Static Psoriasis Global Assessment (sPGA) Score 0 (Complete Clearance) or 1 (Minimal Disease) at Week 12 | 24.0 | 36.0 | 54.2 | 58.3 | 36.0 | 50.0 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether 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 or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
| Participants | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Any TEAE | 12 | 27 | 9 | 26 | 7 | 8 |
| Any TESAE | 1 | 1 | 0 | 0 | 1 | 0 |
| Any TEAESI | 1 | 4 | 0 | 1 | 0 | 0 |
| Any TEAE leading to study treatment discontinuation | 1 | 5 | 0 | 1 | 1 | 0 |
| Any TEAE leading to study treatment withdrawal | 0 | 1 | 0 | 2 | 0 | 0 |
Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.
| nanogram per milliliter (ng/mL) | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|
| Week 2 | 289.714 ± 178.652 | 115.745 ± 79.341 | 71.126 ± 33.287 | 32.581 ± 18.090 | 16.685 ± 9.880 |
| Week 4 | 294.928 ± 193.309 | 110.083 ± 72.664 | 74.071 ± 41.391 | 31.011 ± 18.041 | 17.089 ± 10.061 |
| Week 8 | 285.981 ± 200.600 | 101.216 ± 63.100 | 66.287 ± 50.241 | 34.729 ± 21.556 | 14.566 ± 14.117 |
| Week 12 | 242.188 ± 151.416 | 86.317 ± 53.575 | 56.216 ± 34.269 | 30.711 ± 22.277 | 14.650 ± 10.029 |
Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.
| ng/mL | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|
| Day 1 | 135.396 ± 77.175 | 58.449 ± 25.096 | 132.462 ± 71.387 | 59.010 ± 34.099 | 33.008 ± 16.583 |
| Week 2 | 438.750 ± 243.198 | 151.108 ± 72.612 | 158.463 ± 88.156 | 115.275 ± 49.937 | 56.667 ± 16.388 |
| Week 4 | 432.998 ± 224.552 | 176.800 ± 87.429 | 184.854 ± 91.237 | 89.428 ± 45.908 | 45.145 ± 28.222 |
| Week 8 | 428.111 ± 291.601 | 183.570 ± 101.811 | 222.750 ± 168.237 | 100.190 ± 59.421 | 51.175 ± 35.799 |
| Week 12 | 401.897 ± 191.133 | 150.990 ± 80.672 | 153.229 ± 86.896 | 86.200 ± 41.862 | 42.877 ± 24.508 |
Collected over Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/35 (0%) | 1/35 (2.9%) | 12/35 (34.3%) |
| SAR441566 200 mg BID | 0/47 (0%) | 1/47 (2.1%) | 27/47 (57.4%) |
| SAR441566 100 mg BID | 0/24 (0%) | 0/24 (0%) | 9/24 (37.5%) |
| SAR441566 200 mg QD | 0/46 (0%) | 0/46 (0%) | 26/46 (56.5%) |
| SAR441566 100 mg QD | 0/45 (0%) | 1/45 (2.2%) | 6/45 (13.3%) |
| SAR441566 50 mg QD | 0/24 (0%) | 0/24 (0%) | 8/24 (33.3%) |
| Event | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| Fracture Of PenisInjury, poisoning and procedural complications | 1/35 | 0/47 | 0/24 | 0/46 | 0/45 | 0/24 |
| Staphylococcal SepsisInfections and infestations | 0/35 | 0/47 | 0/24 | 0/46 | 1/45 | 0/24 |
| Benign Pancreatic NeoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/35 | 1/47 | 0/24 | 0/46 | 0/45 | 0/24 |
| Event | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD |
|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/35 | 5/47 | 2/24 | 2/46 | 1/45 | 3/24 |
| DysgeusiaNervous system disorders | 0/35 | 5/47 | 0/24 | 0/46 | 0/45 | 0/24 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/35 | 0/47 | 2/24 | 2/46 | 0/45 | 0/24 |
| HeadacheNervous system disorders | 2/35 | 2/47 | 1/24 | 3/46 | 0/45 | 1/24 |
| Abdominal PainGastrointestinal disorders | 0/35 | 3/47 | 0/24 | 0/46 | 0/45 | 0/24 |
| Alanine Aminotransferase IncreasedInvestigations | 2/35 | 3/47 | 0/24 | 0/46 | 0/45 | 0/24 |
| Blood Alkaline Phosphatase IncreasedInvestigations | 0/35 | 3/47 | 1/24 | 0/46 | 0/45 | 0/24 |
| NauseaGastrointestinal disorders | 1/35 | 2/47 | 0/24 | 2/46 | 0/45 | 0/24 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 0/35 | 0/47 | 0/24 | 2/46 | 0/45 | 0/24 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 0/35 | 2/47 | 0/24 | 2/46 | 0/45 | 0/24 |
The randomized population included all participants from screened population who were allocated to a randomized study treatment by interactive web response system regardless of whether the study treatment was received.
| Age, Continuous(years) | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD | Total |
|---|---|---|---|---|---|---|---|
| Mean | 44.0 ± 13.0 | 43.5 ± 13.7 | 45.5 ± 11.0 | 45.4 ± 13.9 | 46.8 ± 12.9 | 38.4 ± 13.2 | 44.3 ± 13.2 |
| Sex: Female, Male(Participants) | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD | Total |
|---|---|---|---|---|---|---|---|
| Female | 13 | 14 | 10 | 12 | 13 | 13 | 75 |
| Male | 22 | 33 | 14 | 34 | 32 | 11 | 146 |
| Race (NIH/OMB)(Participants) | Placebo | SAR441566 200 mg BID | SAR441566 100 mg BID | SAR441566 200 mg QD | SAR441566 100 mg QD | SAR441566 50 mg QD | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 5 | 7 | 6 | 8 | 4 | 2 | 32 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 2 | 0 | 3 |
| Black or African American | 0 | 1 | 2 | 0 | 2 | 1 | 6 |
| White | 29 | 38 | 14 | 37 | 37 | 21 | 176 |
| More than one race | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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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Studies of the drug tested here: Balinatunfib