A Study to Evaluate Efficacy and Safety of SAR441566 in A... | NCT06073119 | Trialant
NCT06073119
Sponsor
Sanofi
Status
Completed
Last Update Posted
Nov 10, 2025Actual
Enrollment
221Actual
Phase
Phase 2
Conditions
Psoriasis
Interventions
SAR441566
Placebo
Countries
United States
Argentina
Bulgaria
Canada
Chile
China
Czechia
Georgia
Germany
Hungary
Japan
Mauritius
Poland
Portugal
Spain
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT06073119
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DRI17849
Secondary IDs
ID
Type
Description
Link
2023-503911-14
Registry Identifier
CTIS
U1111-1290-5787
Registry Identifier
ICTRP
2023-503911-14-00
Registry Identifier
CTIS
2023-503911-14
EudraCT Number
Brief Title
A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Official Title
A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Plaque Psoriasis
Acronym
SPECIFI-PSO
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 26, 2023Actual
Primary Completion Date
Nov 13, 2024Actual
Completion Date
Dec 11, 2024Actual
First Submitted Date
Oct 4, 2023
First Submission Date that Met QC Criteria
Oct 4, 2023
First Posted Date
Oct 10, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Oct 13, 2025
Results First Submitted that Met QC Criteria
Oct 27, 2025
Results First Posted Date
Nov 10, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 27, 2025
Last Update Posted Date
Nov 10, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
The overall study duration for each participant was up to 149 days.
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
221Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SAR441566 dose regimen A
Experimental
Participants received dose regimen A of SAR441566
Drug: SAR441566
SAR441566 dose regimen B
Experimental
Participants received dose regimen B of SAR441566
Drug: SAR441566
SAR441566 dose regimen C
Experimental
Participants received dose regimen C of SAR441566
Drug: SAR441566
SAR441566 dose regimen D
Experimental
Participants received dose regimen D of SAR441566
Drug: SAR441566
SAR441566 dose regimen E
Experimental
Participants received dose regimen E of SAR441566
Drug: SAR441566
Placebo
Placebo Comparator
Participants received SAR441566 matching placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SAR441566
Drug
Tablet
SAR441566 dose regimen A
SAR441566 dose regimen B
SAR441566 dose regimen C
SAR441566 dose regimen D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline (Day 1) and Week 12
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and D1 (prior to randomization):
PASI ≥ 12 points;
and sPGA score ≥ 3 points;
and BSA score ≥ 10%
Had to be a candidate for phototherapy or systemic therapy.
Total body weight ≥ 50 kg (110 lb) and body mass index (BMI) within the range [18 - 35] kg/m^2 (inclusive)
Exclusion Criteria:
Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis was accepted for inclusion.
Plaque psoriasis was restricted to scalp, palms, soles, or flexures only.
Any other skin diseases that could interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection)
Other immunologic (autoimmune or inflammatory) disorder, except medically controlled diabetes or thyroid disorder as per Investigator's judgement
History of recurrent or recent serious infection (eg, pneumonia, septicemia), or infection(s) requiring hospitalization or treatment with IV antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
Participant with personal or family history of long QT syndrome
History of moderate to severe congestive heart failure (New York Heart Association Class III or IV), or recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would have put the participant at risk by participation in the protocol
History of solid organ transplant
History of alcohol or drug abuse within the past 2 years
History of diagnosis of demyelinating disease such as but not limited to:
Multiple Sclerosis
Acute Disseminated Encephalomyelitis
Balo's Disease (Concentric Sclerosis)
Charcot-Marie-Tooth Disease
Guillain-Barre Syndrome
Human T-lymphotropic virus 1 Associated Myelopathy
Neuromyelitis Optica (Devic's Disease)
Planned surgery during the treatment period
Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin
Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or planned to receive one during the trial
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences and Operations
Sanofi
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Scottsdale Clinical Trials Site Number : 8400025
Scottsdale
Arizona
85260
United States
Dermatology Research Associates- Site Number : 8400019
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
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
221 participants were randomized in 2 different strata: naïve targeted immunotherapy population (NTIP) and experienced targeted immunotherapy population (ETIP). 147 participants were randomized into NTIP in 1:1:1:1:1:1 ratio to receive either placebo or SAR441566 at 200 mg BID, 100 mg BID, 200 mg QD, 100 mg QD or 50 mg QD. 74 participants were randomized into ETIP in 2:2:2:1 ratio to receive either placebo or SAR441566 at 200 mg BID, 200 mg QD, 100 mg QD. ETIP was used for exploratory analysis.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
FG001
SAR441566 200 mg BID
Participants received 200 milligrams (mg) twice a day (BID) of SAR441566 orally from Day 1 up to 12 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 25, 2024
Oct 13, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Placebo
SAR441566 dose regimen E
Placebo
Drug
Tablet
Placebo
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.
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.
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.
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.
2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12
Los Angeles
California
90045
United States
Daxia Trials Site Number : 8400022
Boca Raton
Florida
33431
United States
Renaissance Research and Medical Group, Inc- Site Number : 8400018
Cape Coral
Florida
33991
United States
Driven Research, LLC- Site Number : 8400012
Coral Gables
Florida
33134
United States
FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
Fort Lauderdale
Florida
33308
United States
Direct Helpers Medical Center Inc- Site Number : 8400023
Hialeah
Florida
33012
United States
FXM Clinical Research Miami, LLC- Site Number : 8400016
Miami
Florida
33175
United States
Center for Clinical Studies, LTD. LLP- Site Number : 8400007
Houston
Texas
77004
United States
Center for Clinical Studies, LTD, LLP- Site Number : 8400013
Webster
Texas
77598
United States
Jordan Valley Dermatology Center- Site Number : 8400027
South Jordan
Utah
84095
United States
Investigational Site Number : 0320003
CABA
Buenos Aires
C1023AAB
Argentina
Investigational Site Number : 0320001
Buenos Aires
Buenos Aires F.D.
1060
Argentina
Investigational Site Number : 0320002
CABA
Buenos Aires F.D.
C1425DKG
Argentina
Investigational Site Number : 1000001
Sofia
1404
Bulgaria
Investigational Site Number : 1240006
London
Ontario
N6H 5L5
Canada
Investigational Site Number : 1240002
Waterloo
Ontario
N2J 1C4
Canada
Investigational Site Number : 1520003
Santiago
Reg Metropolitana de Santiago
7580206
Chile
Investigational Site Number : 1520001
Santiago
Reg Metropolitana de Santiago
7640881
Chile
Investigational Site Number : 1520004
Santiago
Reg Metropolitana de Santiago
8330034
Chile
Investigational Site Number : 1520002
Santiago
Reg Metropolitana de Santiago
8420383
Chile
Investigational Site Number : 1560001
Hangzhou
310009
China
Investigational Site Number : 1560002
Wuxi
610017
China
Investigational Site Number : 2030003
Brno
602 00
Czechia
Investigational Site Number : 2680002
Batumi
6000
Georgia
Investigational Site Number : 2680001
Tbilisi
0179
Georgia
Investigational Site Number : 2760004
Blankenfelde-Mahlow
15827
Germany
Investigational Site Number : 2760001
Frankfurt am Main
60590
Germany
Investigational Site Number : 2760002
Witten
58453
Germany
Investigational Site Number : 3480003
Budapest
1083
Hungary
Investigational Site Number : 3480002
Debrecen
4032
Hungary
Investigational Site Number : 3920004
Kamimashiki Gun
Kumamoto
861-3106
Japan
Investigational Site Number : 3920003
Sakai-shi
Osaka
593-8324
Japan
Investigational Site Number : 3920006
Itabashi-ku
Tokyo
173-8610
Japan
Investigational Site Number : 3920002
Tachikawa-shi
Tokyo
190-0023
Japan
Investigational Site Number : 3920005
Ichikawa-shi
272-0033
Japan
Investigational Site Number : 3920001
Yokohama
221-0825
Japan
Investigational Site Number : 4800001
Quatre Bornes
72218
Mauritius
Investigational Site Number : 6160001
Bydgoszcz
85-796
Poland
Investigational Site Number : 6160002
Katowice
40-081
Poland
Investigational Site Number : 6200003
Guimarães
4810-061
Portugal
Investigational Site Number : 6200002
Lisbon
1649-035
Portugal
Investigational Site Number : 6200001
Lisbon
1998-018
Portugal
Investigational Site Number : 7240003
Manises
Valencia
46940
Spain
Investigational Site Number : 7240007
Alicante
03010
Spain
Investigational Site Number : 7240005
Madrid
28040
Spain
Investigational Site Number : 7240004
Madrid
28041
Spain
Investigational Site Number : 7240002
Zaragoza
50009
Spain
Investigational Site Number : 7920002
Antalya
07070
Turkey (Türkiye)
Investigational Site Number : 7920001
Kayseri
38039
Turkey (Türkiye)
Investigational Site Number : 8260001
Manchester
M23 9QZ
United Kingdom
FG002
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
FG003
SAR441566 200 mg QD
Participants received 200 mg once a day (QD) of SAR441566 orally from Day 1 up to 12 weeks.
FG004
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
FG005
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
FG00035 subjects
FG00147 subjects
FG00224 subjects
FG00346 subjects
FG00445 subjects
FG00524 subjects
COMPLETED
FG00027 subjects
FG00136 subjects
FG00220 subjects
FG00341 subjects
FG00439 subjects
FG00523 subjects
NOT COMPLETED
FG0008 subjects
FG00111 subjects
FG0024 subjects
FG0035 subjects
FG0046 subjects
FG0051 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Non-compliance with study schedule
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0035 subjects
FG004
Other
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG0030 subjects
FG004
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
BG001
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
BG002
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
BG003
SAR441566 200 mg QD
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
BG004
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
BG005
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00147
BG00224
BG00346
BG00445
BG00524
BG006221
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.0± 13.0
BG00143.5± 13.7
BG00245.5± 11.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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 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.
The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
Posted
Number
percentage of participants
Baseline (Day 1) and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG002
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG003
SAR441566 200 mg QD
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
OG004
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
OG005
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
Units
Counts
Participants
OG00025
OG00125
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00144.0
OG00250.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Adjusted for baseline PASI score (<=20, >20).
0.0874
A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.
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.
The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (Day 1) to Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
Secondary
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.
The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
Posted
Number
percentage of participants
Baseline (Day 1) and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 200 mg BID
Secondary
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.
The safety population included all randomized participants who took at least 1 dose of study treatment, regardless of the amount of treatment administered.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days
ID
Title
Description
OG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 200 mg BID
Secondary
Pre-Dose Plasma Concentration of SAR441566
Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.
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.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
1 hour pre-dose on Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG002
SAR441566 200 mg QD
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
OG003
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
Secondary
Post-Dose Plasma Concentration of SAR441566
Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.
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.
Posted
Mean
Standard Deviation
ng/mL
2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG001
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
OG002
SAR441566 200 mg QD
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
OG003
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
Time Frame
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.
Description
Analysis was performed on the safety population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
0
35
1
35
12
35
EG001
SAR441566 200 mg BID
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
0
47
1
47
27
47
EG002
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
0
24
0
24
9
24
EG003
SAR441566 200 mg QD
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
0
46
0
46
26
46
EG004
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
0
45
1
45
6
45
EG005
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
0
24
0
24
8
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Staphylococcal Sepsis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected46 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected24 at risk
Benign Pancreatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Fracture Of Penis
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0015 events5 affected47 at risk
EG0022 events2 affected24 at risk
EG0032 events2 affected46 at risk
EG0041 events1 affected45 at risk
EG0053 events3 affected24 at risk
Dysgeusia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0016 events5 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Headache
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0013 events2 affected47 at risk
EG0022 events1 affected24 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected24 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0002 events2 affected35 at risk
EG0014 events3 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events3 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Abscess Limb
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Furuncle
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Localised Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Viral Labyrinthitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Seborrhoeic Keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Idiopathic Neutropenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Diabetic Metabolic Decompensation
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Irritability
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Post-Traumatic Stress Disorder
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Tension
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Burning Sensation
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Syncope
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Eye Irritation
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Faeces Soft
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0013 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Toothache
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Alopecia Areata
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Dandruff
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue
General disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Influenza Like Illness
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Malaise
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Pyrexia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Bilirubin Conjugated Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Electrocardiogram Qt Interval Abnormal
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected24 at risk
EG003
Pregnancy Of Partner
Social circumstances
MedDra 27.1
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.
A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.