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(352) 733-0111

AEVI-007

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.

Details

Full study title A Phase 1b, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of AEVI-007 in Subjects with Adult Onset Still s Disease
Protocol number OCR39998
ClinicalTrials.gov ID NCT04752371
Phase Phase 1

Eligibility

Inclusion Criteria:

  1. Subject is 18 to 75 years of age (inclusive) at the time of consent. The date of signature of the informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).

  2. Subject has been diagnosed with AOSD based on classification criteria (according to Yamaguchi et al, 1992) defined as having 5 or more of the following criteria, 2 of

Which are major:

a. Major Criteria i. Fever >39°C, lasting 1 week or longer ii. Arthralgia or

arthritis, lasting 2 weeks or longer iii. Typical rash iv. Leukocytes >10,000 mm3 with

>80% polymorphonuclear cells b. Minor Criteria i. Sore throat ii. Recent development

of significant lymphadenopathy iii. Hepatomegaly or splenomegaly iv. Abnormal liver

function tests v. Negative tests for antinuclear antibody and rheumatoid factor

  1. Subject has reported a recurring fever >38°C, consistent with active disease, within the last 5 days of the Screening and Baseline Visits.

  2. If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAID), subject is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).

  3. If undergoing treatment with glucocorticoids, subject is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).

  4. If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), subject is on a stable dose for at least 4 weeks prior to the Baseline Visit (Visit 2).

  5. For subjects who have received treatment with biological DMARDs, subject has the required washout (normalization) period prior to the Baseline Visit (Visit 2). The washout (normalization) period for biological DMARDs is as follows:

    1. Anakinra * 1 week

    2. Etanercept, rilonacept * 4 weeks

    3. Adalimumab, certolizumab, infliximab, golimumab, abatacept, tocilizumab and canakinumab * 8 weeks

    4. Rituximab * 36 weeks

  6. Non-pregnant female subjects of childbearing potential who are heterosexually active and non-sterile male subjects with female sexual partners of childbearing potential agree to use a highly effective method of contraception during treatment and for 25 weeks following the last dose of investigational product. A highly effective method of birth control is defined as one that results in a low failure rate (ie,

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

    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.