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Telitacicept in Primary APS Patients

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05078710
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
18
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Telitacicept Treatment in Primary APS Patients
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telitacicept arm

Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.

Drug: Telitacicept
160mg once a week for 24 weeks
Other Names:
  • traditional antithrombotic and immunosuppressive treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. new thrombotic event [24 weeks]

      any new thrombotic event during Telitacicept treatment

    Secondary Outcome Measures

    1. improvement of thrombocytopenia during Telitacicept treatment [24 weeks]

      elevated platelet counts

    2. improvement of hemolytic anemia during Telitacicept treatment [24 weeks]

      elevated hemoglobin

    3. improvement of aPL nephropathy during Telitacicept treatment [24 weeks]

      decrease of proteinuria or creatinine

    4. improvement of valve heart disease during Telitacicept treatment [24 weeks]

      decrease of valve thickness or vegetation by echocardiogram

    5. improvement of neurological manifestations during Telitacicept treatment [24 weeks]

      MRI improvement

    6. decrease of aPL titer during Telitacicept treatment [24 weeks]

      titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • meet 2006 Sapporo classification criteria of APS;

    • diagnosis of primary APS, exclude other etiologies of thrombosis;

    • with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;

    • with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.

    Exclusion Criteria:

    • overlap with other connective tissue diseases, such as systemic lupus erythematosus;

    • during pregnancy;

    • can not follow-up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Jiuliang Zhao, M.D., Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05078710
    Other Study ID Numbers:
    • PUMCH-ZS-3026
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    anti phospholipid syndrome
    Additional relevant MeSH terms:
    Antiphospholipid Syndrome
    Immunosuppressive Agents

    Study Results

    No Results Posted as of Oct 14, 2021