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

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073119
• Other study ID #: DRI17849
• Secondary ID: 2023-503911-14U1
• Status: Recruiting
• Phase: Phase 2
• Start date: October 26, 2023
• Est. completion date: May 8, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The overall study duration for each participant will be approximately up to 135 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 207
• Est. completion date: May 8, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• SAR441566
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320001	Buenos Aires	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320002	Caba	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320003	Caba	Buenos Aires
Canada	Investigational Site Number : 1240006	London	Ontario
Canada	Investigational Site Number : 1240002	Waterloo	Ontario
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520004	Santiago	Reg Metropolitana De Santiago
China	Investigational Site Number : 1560001	Hangzhou
China	Investigational Site Number : 1560002	Wuxi
Czechia	Investigational Site Number : 2030003	Brno
Georgia	Investigational Site Number : 2680002	Batumi
Georgia	Investigational Site Number : 2680001	Tbilisi
Germany	Investigational Site Number : 2760003	Berlin
Germany	Investigational Site Number : 2760004	Blankenfelde-Mahlow
Germany	Investigational Site Number : 1000001	Dusseldorf
Germany	Investigational Site Number : 2760001	Frankfurt am Main
Germany	Investigational Site Number : 2760002	Witten
Hungary	Investigational Site Number : 3480003	Budapest
Hungary	Investigational Site Number : 3480002	Debrecen
Japan	Investigational Site Number : 3920005	Ichikawa-shi
Japan	Investigational Site Number : 3920006	Itabashi-ku	Tokyo
Japan	Investigational Site Number : 3920004	Kamimashiki Gun	Kumamoto
Japan	Investigational Site Number : 3920003	Sakai-shi	Osaka
Japan	Investigational Site Number : 3920002	Tachikawa-shi	Tokyo
Japan	Investigational Site Number : 3920001	Yokohama-Shi	Kanagawa
Mauritius	Investigational Site Number : 4800001	Quatre Bornes
Poland	Investigational Site Number : 6160001	Bydgoszcz
Poland	Investigational Site Number : 6160002	Katowice
Portugal	Investigational Site Number : 6200003	Guimarães
Portugal	Investigational Site Number : 6200001	Lisboa
Portugal	Investigational Site Number : 6200002	Lisboa
Spain	Investigational Site Number : 7240007	Alicante
Spain	Investigational Site Number : 7240001	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240004	Madrid
Spain	Investigational Site Number : 7240005	Madrid
Spain	Investigational Site Number : 7240003	Manises	Valencia
Spain	Investigational Site Number : 7240002	Zaragoza
Turkey	Investigational Site Number : 7920002	Antalya
Turkey	Investigational Site Number : 7920001	Kayseri
United Kingdom	Investigational Site Number : 8260001	Manchester
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	First OC Dermatology Site Number : 8400005	Fountain Valley	California
United States	Center for Dermatology Clinical Research, Inc. Site Number : 8400003	Fremont	California
United States	Direct Helpers Medical Center Inc Site Number : 8400023	Hialeah	Florida
United States	Center for Clinical Studies, LTD. LLP Site Number : 8400007	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC Site Number : 8400008	Indianapolis	Indiana
United States	Dermatology Research Associates Site Number : 8400019	Los Angeles	California
United States	FXM Clinical Research Miami, LLC Site Number : 8400016	Miami	Florida
United States	Therapeutics Clinical Research Site Number : 8400006	San Diego	California
United States	Scottsdale Clinical Trials Site Number : 8400025	Scottsdale	Arizona
United States	Jordan Valley Dermatology Center Site Number : 8400027	South Jordan	Utah
United States	Center for Clinical Studies, LTD, LLP Site Number : 8400013	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  China,  Czechia,  Georgia,  Germany,  Hungary,  Japan,  Mauritius,  Poland,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to Week 12
Secondary	PASI change from baseline to week 12		Baseline to week 12
Secondary	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.	Baseline to week 12
Secondary	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).	Baseline to week 14
Secondary	Plasma pre-dose concentrations of SAR441566		Week 2 to week 12
Secondary	Plasma post-dose concentrations of SAR441566		Week 0 to week 12