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A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (SPECIFI-PSO)

Primary Purpose

Psoriasis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SAR441566
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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% Must 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 is accepted for inclusion. Plaque psoriasis is restricted to scalp, palms, soles, or flexures only. Any other skin diseases that can 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 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 plan to receive one during the trial The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    SAR441566 dose regimen A

    SAR441566 dose regimen B

    SAR441566 dose regimen C

    SAR441566 dose regimen D

    SAR441566 dose regimen E

    Placebo

    Arm Description

    Participants will receive dose regimen A of SAR441566

    Participants will receive dose regimen B of SAR441566

    Participants will receive dose regimen C of SAR441566

    Participants will receive dose regimen D of SAR441566

    Participants will receive dose regimen E of SAR441566

    Participants will receive SAR441566 matching placebo

    Outcomes

    Primary Outcome Measures

    Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12
    The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 (no disease) to 72 (maximal disease). It is a linear combination of percent of surface area of skin (A) that is affected (1 [<10%] to 6 [90% - 100%]) and the severity of erythema [E], induration [I], and desquamation [D] on a scale from 0=no symptoms to 4=very marked over four body regions : head (h), trunk (t), upper extremities (u) and lower extremities (l). 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

    Secondary Outcome Measures

    PASI change from baseline to week 12
    Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) from baseline to week 12
    The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
    Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs).
    Plasma pre-dose concentrations of SAR441566
    Plasma post-dose concentrations of SAR441566

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06073119
    Brief Title
    A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
    Acronym
    SPECIFI-PSO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 16, 2023 (Anticipated)
    Primary Completion Date
    March 13, 2025 (Anticipated)
    Study Completion Date
    April 24, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sanofi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is 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 include 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) (2 weeks ± 3 days). The total number of study visits will be 7.
    Detailed Description
    The overall study duration for each participant will be approximately up to 135 days.

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    207 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SAR441566 dose regimen A
    Arm Type
    Experimental
    Arm Description
    Participants will receive dose regimen A of SAR441566
    Arm Title
    SAR441566 dose regimen B
    Arm Type
    Experimental
    Arm Description
    Participants will receive dose regimen B of SAR441566
    Arm Title
    SAR441566 dose regimen C
    Arm Type
    Experimental
    Arm Description
    Participants will receive dose regimen C of SAR441566
    Arm Title
    SAR441566 dose regimen D
    Arm Type
    Experimental
    Arm Description
    Participants will receive dose regimen D of SAR441566
    Arm Title
    SAR441566 dose regimen E
    Arm Type
    Experimental
    Arm Description
    Participants will receive dose regimen E of SAR441566
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive SAR441566 matching placebo
    Intervention Type
    Drug
    Intervention Name(s)
    SAR441566
    Intervention Description
    Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Tablet
    Primary Outcome Measure Information:
    Title
    Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12
    Description
    The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 (no disease) to 72 (maximal disease). It is a linear combination of percent of surface area of skin (A) that is affected (1 [<10%] to 6 [90% - 100%]) and the severity of erythema [E], induration [I], and desquamation [D] on a scale from 0=no symptoms to 4=very marked over four body regions : head (h), trunk (t), upper extremities (u) and lower extremities (l). 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
    Time Frame
    Baseline to Week 12
    Secondary Outcome Measure Information:
    Title
    PASI change from baseline to week 12
    Time Frame
    Baseline to week 12
    Title
    Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) from baseline to week 12
    Description
    The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
    Time Frame
    Baseline to week 12
    Title
    Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    Description
    Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs).
    Time Frame
    Baseline to week 14
    Title
    Plasma pre-dose concentrations of SAR441566
    Time Frame
    Week 2 to week 12
    Title
    Plasma post-dose concentrations of SAR441566
    Time Frame
    Week 0 to week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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% Must 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 is accepted for inclusion. Plaque psoriasis is restricted to scalp, palms, soles, or flexures only. Any other skin diseases that can 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 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 plan to receive one during the trial The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Trial transparency email recommended (Toll free for US & Canada)
    Phone
    800-633-1610
    Ext
    Option 6
    Email
    contact-us@sanofi.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Sciences and Operations
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    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

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

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