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

CompletadoFase 2ClinicalTrials.gov

ID: NCT06073119Tipo: INTERVENTIONALInicio: 26 de oct de 2023Fin estimado: 11 de dic de 2024

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Resumen

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.

Descripción detallada

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

SAR441566

Tablet

drug

Placebo

Tablet

Ubicaciones

Investigational Site Number : 0320003

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320002

CABA, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalSanofi

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