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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
221
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
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Scottsdale Clinical Trials Site Number : 8400025
Scottsdale, Arizona, United States
Dermatology Research Associates- Site Number : 8400019
Los Angeles, California, United States
Daxia Trials Site Number : 8400022
Boca Raton, Florida, United States
Renaissance Research and Medical Group, Inc- Site Number : 8400018
Cape Coral, Florida, United States
Driven Research, LLC- Site Number : 8400012
Coral Gables, Florida, United States
FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
Fort Lauderdale, Florida, United States
Direct Helpers Medical Center Inc- Site Number : 8400023
Hialeah, Florida, United States
FXM Clinical Research Miami, LLC- Site Number : 8400016
Miami, Florida, United States
Center for Clinical Studies, LTD. LLP- Site Number : 8400007
Houston, Texas, United States
Center for Clinical Studies, LTD, LLP- Site Number : 8400013
Webster, Texas, United States
...and 41 more locations
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