Psoriasis
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Psoriasis
DRI17849 Enrolling

Clinical Trial: Moderate-to-Severe Plaque Psoriasis


Treatment: Oral Age: 18 Years


Who can participate?

Recruitment opens for adults at least 18 years old to 75 years of age (inclusive) at the time of signing the informed consent.

Inclusion Criteria:

  • Have moderate to severe Plaque Psoriasis for at least 6 months.
  • Must be a candidate for phototherapy or systemic therapy.
  • Total body weight of ≥50 kg (110 lb.) and body mass index (BMI) within the range [18 – 35] kg/m² (inclusive).
  • Must not have other forms of psoriasis other than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion.

What are the benefits?

As a participant in our research trial, you will receive an oral investigational treatment (active study drug) or placebo entirely free of cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.

How long will the study last?

  • 14 weeks with 7 visits to the study centre.

Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Wei Jing Loo

Dermatologist

Dr. Kim Alexander Papp

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: April 07, 2024

Official Title

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

ClinicalTrials.gov ID

NCT06073119

Sponsor

Sanofi

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:

    Psoriasis

  • Intervention/Treatment:

    Drug: SAR441566
    Drug: SAR441566
    Drug: SAR441566
    Drug: SAR441566
    Drug: SAR441566
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

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.
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 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 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

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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