Clinical trial NCT06073119: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) (4 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 149 days.

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

Primary outcomes:
measure: Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: PASI percent change from baseline to week 12
timeFrame: Baseline to week 12
measure: Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12
timeFrame: Week 12
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
timeFrame: Baseline to week 16
measure: Plasma pre-dose concentrations of SAR441566
timeFrame: Week 2 to week 12
measure: Plasma post-dose concentrations of SAR441566
timeFrame: Week 0 to week 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials Site Number : 8400025
state: Arizona
city: Los Angeles
country: United States
facility: Dermatology Research Associates- Site Number : 8400019
state: California
city: Boca Raton
country: United States
facility: Daxia Trials Site Number : 8400022
state: Florida
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group, Inc- Site Number : 8400018
state: Florida
city: Coral Gables
country: United States
facility: Driven Research, LLC- Site Number : 8400012
state: Florida
city: Fort Lauderdale
country: United States
facility: FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Medical Center Inc- Site Number : 8400023
state: Florida
city: Miami
country: United States
facility: FXM Clinical Research Miami, LLC- Site Number : 8400016
state: Florida
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP- Site Number : 8400007
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD, LLP- Site Number : 8400013
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center- Site Number : 8400027
state: Utah
city: Caba
country: Argentina
facility: Investigational Site Number : 0320003
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
state: Ciudad De Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320002
state: Ciudad De Buenos Aires
city: London
country: Canada
facility: Investigational Site Number : 1240006
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Hangzhou
country: China
facility: Investigational Site Number : 1560001
city: Wuxi
country: China
facility: Investigational Site Number : 1560002
city: Brno
country: Czechia
facility: Investigational Site Number : 2030003
city: Batumi
country: Georgia
facility: Investigational Site Number : 2680002
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680001
city: Berlin
country: Germany
facility: Investigational Site Number : 2760003
city: Blankenfelde-Mahlow
country: Germany
facility: Investigational Site Number : 2760004
city: Dusseldorf
country: Germany
facility: Investigational Site Number : 1000001
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number : 2760001
city: Witten
country: Germany
facility: Investigational Site Number : 2760002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480003
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3480002
city: Kamimashiki Gun
country: Japan
facility: Investigational Site Number : 3920004
state: Kumamoto
city: Sakai-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Osaka
city: Itabashi-ku
country: Japan
facility: Investigational Site Number : 3920006
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Tokyo
city: Ichikawa-shi
country: Japan
facility: Investigational Site Number : 3920005
city: Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920001
city: Quatre Bornes
country: Mauritius
facility: Investigational Site Number : 4800001
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160001
city: Katowice
country: Poland
facility: Investigational Site Number : 6160002
city: Guimarães
country: Portugal
facility: Investigational Site Number : 6200003
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200002
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200001
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Manises
country: Spain
facility: Investigational Site Number : 7240003
state: Valencia
city: Alicante
country: Spain
facility: Investigational Site Number : 7240007
city: Madrid
country: Spain
facility: Investigational Site Number : 7240005
city: Madrid
country: Spain
facility: Investigational Site Number : 7240004
city: Zaragoza
country: Spain
facility: Investigational Site Number : 7240002
city: Antalya
country: Turkey
facility: Investigational Site Number : 7920002
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920001
city: Manchester
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
affiliation: Sanofi
name: Clinical Sciences and Operations
role: STUDY_DIRECTOR
References: