BridgeMD
A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis
EU CTIS ID: 2023-503911-14-00
What this study is testing
To demonstrate the superiority of SAR441566 over placebo in participants with moderate to severe plaque psoriasis, in the Naïve Targeted Immunotherapy Population (NTIP)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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%,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/m2 (inclusive).
You likely can't join if
- Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion.
- 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.
See the full eligibility 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%,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/m2 (inclusive).
- Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion.
- 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.
- 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 anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral anti-infectives (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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- Chile
- United States
- Georgia
- Canada
- Turkey
- Argentina
- China
- Mauritius
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; Chile; United States; Georgia; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.