Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(904) 244-0411

SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE

  • Status
    Accepting Candidates
  • Age
    18 Years - 63 Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Description

The purpose of this program is to assess the safety and efficacy of upadacitinib compared with placebo (fake drug) for the treatment of signs and symptoms in adults with moderately to severely active systemic lupus erythematosus (SLE, also called lupus)

Details

Protocol number 20233520

Eligibility

Inclusion criteria:

- Subjects or their legally authorized representative (if required per local regulations) must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.

- Clinical diagnosis of SLE at least 24 weeks prior to Screening as defined by the 2019 EULAR/ACR classification criteria for SLE.

- The subject must be on stable background treatment for ≥ 30 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for ≥14 days prior to Baseline)

- Must not have prior exposure to a JAK inhibitor (including Tyk2 inhibitors), including but not limited to commercial upadacitinib (Rinvoq®), tofacitinib (Xeljanz®), ruxolitinib (Jakafi® or Opzelura®), baricitinib (Olumiant®), peficitinib (Smyraf®), abrocitinib (Cibinqo®), filgotinib (Jyseleca®), fedratinib (Inrebic), and deucravacitinib (Sotyktu®).

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  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

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.