A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis

JRCT ID: jRCT2061230086

Registered date:09/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Psoriasis
• Date of first enrollment: 13/02/2024
• Target sample size: 207
• Countries of recruitment: United States,Japan,Canada,Japan
• Study type: Interventional

Intervention(s)

Drug: SAR441566
Pharmaceutical form: Tablet, Route of administration: Oral
Drug: Placebo
Pharmaceutical form: Tablet, Route of administration: Oral

Arm description:
- Experimental: SAR441566 dose regimen A
Participants will receive dose regimen A of SAR441566. Intervention: Drug: SAR441566
- Experimental: SAR441566 dose regimen B
Participants will receive dose regimen B of SAR441566. Intervention: Drug: SAR441566
- Experimental: SAR441566 dose regimen C
Participants will receive dose regimen C of SAR441566. Intervention: Drug: SAR441566
- Experimental: SAR441566 dose regimen D
Participants will receive dose regimen D of SAR441566. Intervention: Drug: SAR441566
- Experimental: SAR441566 dose regimen E
Participants will receive dose regimen E of SAR441566. Intervention: Drug: SAR441566
- Placebo Comparator: Placebo
Participants will receive SAR441566 matching placebo. Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

1. Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at Week 12.
[Time frame: Baseline to 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

1. PASI change from baseline to Week 12.
[Time frame: Baseline to week 12]
2. Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) from baseline to Week 12.
[Time frame: 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.
3. Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs).
[Time frame: Baseline to week 14]
Incidence of TEAEs, SAEs, and AESIs.
4. Plasma pre-dose concentrations of SAR441566.
[Time frame: Week 2 to week 12]
5. Plasma post-dose concentrations of SAR441566.
[Time frame: Week 0 to week 12]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and Day 1 (prior to randomization):
- - Psoriasis area and severity index (PASI) >=12 points; and
- - Static psoriasis global assessment (sPGA) score >=3 points; and
- - Body surface area (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).

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- 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 intravenous anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to Day 1, or infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to Day 1.
- 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.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT06073119,2023-503911-14-00