Back to resultsA Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
SAR441566
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or female with mild to moderate psoriatic participants, between 18 and 65 years of age, inclusive.
- Body mass index between 18.0 and 35.0 kg/m2, inclusive (body weight not under 50.0 Kg).
- Female participants who are only postmenopausal or are sterilized (e.g post-bilateral surgical oophorectomy not linked to a history of cancer) can be included in the study.
- Participant must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, vital signs, ECG, clinical laboratories, and urinalysis.
- Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months prior to screening with mild to moderate severity, defined as PASI ≤ 16.
- Participant must have at least two lesions with TLSS≥4 at both screening and baseline excluding the scalp.
Exclusion Criteria:
- Pre-existing signs of skin atrophy, telangiectasia or striae in the affected area
- Use of systemic immunosuppressants within 4 weeks of entering the study and during the entire study duration
- Current evidence of non-plaque forms of psoriasis (e.g., erythrodermic, guttate or pustular), psoriatic arthritis
- Currently evidence or suspicion of drug-induced psoriasis (e.g., new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Use of any of the following therapies within 4 weeks prior to Baseline (Day 1): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens
- Use of topical corticosteroid preparations (except hydrocortisone 1%), topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to randomization (Day 1)
- Prior use of any biologicals for treatment of psoriasis
- Participants who received any live vaccination within 3 months, any initial non-live vaccination within 30 days or non-live booster vaccination within 14 days of first IMP administration or intend to receive any vaccination during the study.
- Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (including an ongoing biological proven SARS-CoV-2 infection and recurrent infection) or any condition that may affect participant safety in the judgment of the Investigator including participants who are not adequately vaccinated against a SARS-CoV-2 infection according to local regulations.
- Opportunistic infections within 6 months before randomization (Day 1)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number :2760001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAR441566
Placebo
Arm Description
Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions
Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events (TEAE) including SAE and AESI
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI
Secondary Outcome Measures
Percent change from baseline in the target lesion severity score (TLSS) to weeks 2 and 4
TLSS consists of a sum score of 3 clinical severity parameters (scaling, erythema, plaque elevation/induration; each graded on a 5-point severity scale; 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe/very severe) with a sum score ranging between 0 and 12 points
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05453942
Brief Title
A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Clinical Response After 4-week Oral Treatment With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a parallel, Phase 1, single center, 2-arm, double-blind, randomized, placebo-controlled with a ratio 2 active: 1 placebo study for treatment of mild to moderate psoriasis participants. Approximately 36 participants (24 in the SAR441566 group and 12 in the placebo group) are to be enrolled to have a total of 33 evaluable participants (22 in the SAR441566 group and 11 in the placebo group).
The objective of this study is primarily to evaluate the tolerability and safety and secondarily the clinical response over 4-week oral treatment with SAR441566 in participants with mild to moderate psoriasis. The clinical response is measured by the relative change from baseline in Total Lesion Severity Score (TLSS).
The study comprises an up to 4-week screening period, a 4-week treatment period with SAR441566 or placebo. The end-of-study visit will be carried out 10 ±3 days after the last investigational medicinal product administration. The frequency of visits is once a week during the treatment period.
Detailed Description
Screening period: up to 4 weeks
Treatment: 4 weeks (from Day 1 to Day 28)
End-of-Study: between 7 to 13 days after the last IMP administration (from Day 35 to Day 41) Total study duration: 37 to 69 days maximum (approximately between 6 and 10 weeks)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR441566
Arm Type
Experimental
Arm Description
Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition
Intervention Type
Drug
Intervention Name(s)
SAR441566
Intervention Description
Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAE) including SAE and AESI
Description
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI
Time Frame
Up to 69 days
Secondary Outcome Measure Information:
Title
Percent change from baseline in the target lesion severity score (TLSS) to weeks 2 and 4
Description
TLSS consists of a sum score of 3 clinical severity parameters (scaling, erythema, plaque elevation/induration; each graded on a 5-point severity scale; 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe/very severe) with a sum score ranging between 0 and 12 points
Time Frame
Baseline to week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female with mild to moderate psoriatic participants, between 18 and 65 years of age, inclusive.
Body mass index between 18.0 and 35.0 kg/m2, inclusive (body weight not under 50.0 Kg).
Female participants who are only postmenopausal or are sterilized (e.g post-bilateral surgical oophorectomy not linked to a history of cancer) can be included in the study.
Participant must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, vital signs, ECG, clinical laboratories, and urinalysis.
Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months prior to screening with mild to moderate severity, defined as PASI ≤ 16.
Participant must have at least two lesions with TLSS≥4 at both screening and baseline excluding the scalp.
Exclusion Criteria:
Pre-existing signs of skin atrophy, telangiectasia or striae in the affected area
Use of systemic immunosuppressants within 4 weeks of entering the study and during the entire study duration
Current evidence of non-plaque forms of psoriasis (e.g., erythrodermic, guttate or pustular), psoriatic arthritis
Currently evidence or suspicion of drug-induced psoriasis (e.g., new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Use of any of the following therapies within 4 weeks prior to Baseline (Day 1): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens
Use of topical corticosteroid preparations (except hydrocortisone 1%), topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to randomization (Day 1)
Prior use of any biologicals for treatment of psoriasis
Participants who received any live vaccination within 3 months, any initial non-live vaccination within 30 days or non-live booster vaccination within 14 days of first IMP administration or intend to receive any vaccination during the study.
Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (including an ongoing biological proven SARS-CoV-2 infection and recurrent infection) or any condition that may affect participant safety in the judgment of the Investigator including participants who are not adequately vaccinated against a SARS-CoV-2 infection according to local regulations.
Opportunistic infections within 6 months before randomization (Day 1)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :2760001
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
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