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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE)

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The POETYK SLE-1/SLE-2 (IM011-246/247) studies are two identical studies. If eligible, you will be enrolled in only one of these two studies. Participation may last between approximately 14 and 38 months and consists of a screening period, a double-blind treatment period, an optional open-label long-term extension period, and a follow-up period. Approximately 980 participants will be enrolled in the studies and will be randomized to receive either the investigational medication or a placebo to be taken orally, while remaining on your current standard-of-care treatment. Regardless of whether you are assigned to receive the investigational medication or the placebo, you will still receive the same level of study-related care.

Details

Protocol number 20232025

Eligibility

Eligible participants must:

鈥� Be 18 to 75 years of age

鈥� Have a diagnosis of active SLE with signs and symptoms including joint

involvement and/or rash

鈥� Have positive antibodies (ANA, or anti-dsDANA or anti-Smith) based on

laboratory screening

鈥� Be receiving a background therapy for SLE, such as immunosuppressants

(azathioprine, 6-mercaptopurine, methotrexate, leflunomide, tacrolimus,

mizoribine, or mycophenolate mofetil) and/or antimalarials (chloroquine,

hydroxychloroquine, or quinacrine)

鈥� Participants must not be taking more than one immunosuppressant

鈥� NOT be diagnosed with other autoimmune diseases (e.g., multiple sclerosis,

psoriasis, inflammatory bowel disease, etc.)

鈥� Exceptions: type 1 diabetes mellitus, thyroid autoimmune disease,

celiac disease, and secondary Sj枚gren鈥檚 syndrome

There are additional eligibility criteria, which your study doctor can explain to you.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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