SPECIFI-PSO: A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The overall study duration for each participant will be approximately up to 135 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SAR441566 dose regimen A Participants will receive dose regimen A of SAR441566 |
Drug: SAR441566
Tablet
|
| Experimental: SAR441566 dose regimen B Participants will receive dose regimen B of SAR441566 |
Drug: SAR441566
Tablet
|
| Experimental: SAR441566 dose regimen C Participants will receive dose regimen C of SAR441566 |
Drug: SAR441566
Tablet
|
| Experimental: SAR441566 dose regimen D Participants will receive dose regimen D of SAR441566 |
Drug: SAR441566
Tablet
|
| Experimental: SAR441566 dose regimen E Participants will receive dose regimen E of SAR441566 |
Drug: SAR441566
Tablet
|
| Placebo Comparator: Placebo Participants will receive SAR441566 matching placebo |
Drug: Placebo
Tablet
|
Outcome Measures
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 [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 Measures
- PASI change from baseline to week 12 [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 [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) [Baseline to week 14]
Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs).
- Plasma pre-dose concentrations of SAR441566 [Week 2 to week 12]
- Plasma post-dose concentrations of SAR441566 [Week 0 to week 12]
Eligibility Criteria
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.
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Any other skin diseases that can interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection)
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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
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Participant with personal or family history of long QT syndrome
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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
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History of solid organ transplant
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History of alcohol or drug abuse within the past 2 years
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History of diagnosis of demyelinating disease such as but not limited to:
-
Multiple Sclerosis
-
Acute Disseminated Encephalomyelitis
-
Balo's Disease (Concentric Sclerosis)
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Charcot-Marie-Tooth Disease
-
Guillain-Barre Syndrome
-
Human T-lymphotropic virus 1 Associated Myelopathy
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Neuromyelitis Optica (Devic's Disease)
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Planned surgery during the treatment period
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences and Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DRI17849
- 2023-503911-14-00
- U1111-1290-5787