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Will Be Recruiting
Astellas Study ID
5502-CL-0001

copy from PPLD when it has been finalized Primary Sjögren’s syndrome

Astellas Study ID
5502-CL-0001
Clinicaltrials.gov ID
N/A
EUCTIS ID
test ID #2
EudraCT ID
test ID #1
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

Test with apostrophe in condition field for mapping

copy final text PPLD

Primary Sjögren’s syndrome is a condition when the body’s immune system attacks glands

that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry

mouth. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition.

In this study, ASP5502 is being given to humans for the first time. The people taking part are healthy adults or adults with primary Sjögren’s syndrome.

The main aims of the study are to check the safety of ASP5502 and how people cope with

(tolerate) taking ASP5502 tablets.

This study will be in 3 parts.

In Part 1, healthy men and women will take tablets of ASP5502 or a placebo just once. In

this study, the placebo looks like the ASP5502 tablet but doesn’t have any medicine in it.

Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. One small group will take tablets of ASP5502 or

placebo with and without food.

Additional Study Details

Phase
Phase 1
Product
ASP5502
Product
  • ASP5502
  • Placebo
    • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    140
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for copy from PPLD when it has been finalized Primary Sjögren’s syndrome? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
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    • Austria
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    • Brazil
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    • China
    • Colombia
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    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
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    • Former Serbia and Montenegro
    • France
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    • Slovakia
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    • South Africa
    • Spain
    • Sweden
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    • Taiwan, Province of China
    • Thailand
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    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Trial info
      Age
      18 - 65 Years
      Diamond icon
      Condition
    • Healthy Volunteer
      • Show more
    • Sjogren's Syndrome
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Aug 2024 - Jul 2027
      Additional Study Details
      Inclusion Criteria

        Inclusion Criteria for Healthy Participants

      • Participant is healthy and has no clinically significant medical conditions based on the review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
      • Female participant is not pregnant and at least 1 of the following conditions apply:
        • Not a women of childbearing potential (WOCBP)
        • WOCBP who has a negative blood pregnancy test at screening and a urine pregnancy test on day -1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives or 30 days, whichever is longer, after final study intervention administration. Female participants on hormonal contraceptives must also be using a double barrier method as defined in Contraceptive Requirements.
      • text criteria

        • Inclusion Criteria for Participants with Primary Sjögren’s syndrome (pSS)

      • Participant is diagnosed based on the 2016 American College of Rheumatology (ACR)- European Alliance of Associations for Rheumatology (EULAR) Classification Criteria for pSS . Diagnosis should have been established at least 6 months prior to day -1 and no clinically significant medical condition is present on the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
      • Female participant is not pregnant and at least 1 of the following conditions apply:
        • Not a WOCBP
      • test criteria
      MaximizeExclusion Criteria

        Exclusion Criteria for Healthy Participants

      • Participant has been pregnant within 6 months prior to screening.
      • Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
      • Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).

        • Exclusion Criteria for Participants with pSS

      • Participant has been diagnosed with secondary Sjögren’s syndrome or any other systemic autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
      • Participant has severe complications of Sjögren’s syndrome, such as neurologic or cardiac involvement, interstitial lung disease and severe myositis.
      • Participant is using immunosuppressant therapy (e.g. methotrexate, azathioprine, mycophenolate mofetil), B-cell depleting agents (e.g. rituximab, belimimab), Janus kinase inhibitors (JAKi) (e.g. tofacitinib), calcineurin inhibitors (e.g. tacrolimus, cyclosporin), and other biologics (e.g. abatacept, cyclophosphamide, leflunomide).
      • test only

      Frequently Asked Questions

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