A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

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

Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.

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

Population: The safety population included all randomized participants who took at least 1 dose of study treatment, regardless of the amount of treatment administered.

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

Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.

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

Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.

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

Population: The PK population included all participants from the safety population with at least 1 post-baseline PK result with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.

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

Population: The pharmacokinetic (PK) population included all participants from the safety population with at least 1 post-baseline PK result with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.