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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: SAR441566; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06073119

2023-503911-14-00 (Other Identifier)

2023-503911-14 (Registry Identifier)

U1111-1290-5787 (Registry Identifier)

DRI17849

Details and patient eligibility

About

This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was 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 included 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 was 7.

Full description

The overall study duration for each participant was up to 149 days.

Enrollment: 221 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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%

• Had to 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 was accepted for inclusion.

• Plaque psoriasis was restricted to scalp, palms, soles, or flexures only.

• Any other skin diseases that could 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 have 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 planned to receive one during the trial

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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221 participants in 6 patient groups, including a placebo group

SAR441566 dose regimen A

Experimental group

Description:

Participants received dose regimen A of SAR441566

Treatment:

Drug: SAR441566

SAR441566 dose regimen B

Experimental group

Description:

Participants received dose regimen B of SAR441566

Treatment:

Drug: SAR441566

SAR441566 dose regimen C

Experimental group

Description:

Participants received dose regimen C of SAR441566

Treatment:

Drug: SAR441566

SAR441566 dose regimen D

Experimental group

Description:

Participants received dose regimen D of SAR441566

Treatment:

Drug: SAR441566

SAR441566 dose regimen E

Experimental group

Description:

Participants received dose regimen E of SAR441566

Treatment:

Drug: SAR441566

Placebo

Placebo Comparator group

Description:

Participants received SAR441566 matching placebo

Treatment:

Drug: Placebo