Study of PN20 in Adult Patients with Primary Immune Thrombocytopenia (ITP)

Last updated: March 11, 2025
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Dysfunctional Uterine Bleeding

Thrombosis

White Cell Disorders

Treatment

PN20 treatment

Clinical Study ID

NCT06880081
CQPJ-PN20-ITP-Ib
  • Ages 18-65
  • All Genders

Study Summary

The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP). The main questions it aims to answer are:

  • Is PN20 safe in these patients?

  • Could these patients potentially benefit from PN20 treatment?

Participants will

  • Receive one subcutaneous injection of PN20 according to weight;

  • Visit the clinic for assessment.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Aged between 18 and 65 years (inclusive), male or female;

  2. Diagnosed with primary immune thrombocytopenia (ITP) and have a disease course ofmore than 6 months;

  3. Patients who have no response or relapsed after splenectomy. Or patients who havenot been splenectomised and have completed at least 1 prior treatment for ITP (suchas glucocorticoids, immunoglobulin) and have failed to respond or relapsed aftertreatment;

  4. During screening period, the mean of two platelet counts must be < 30 × 10^9/L, withnone >35 × 10^9/L;

  5. Fully understand and are able to comply with the requirements of the protocol,voluntarily participate and sign the informed consent form.

Exclusion

Key Exclusion Criteria:

  1. History of bone marrow stem cell disorder. Any abnormal bone marrow findings otherthan typical of ITP.

  2. Any active malignancy. If prior history of cancer other than basal cell carcinoma orcervical carcinoma in situ, no treatment or active disease within 5 years prior tosigning the ICF.

  3. Diagnosed with arterial thrombotic disease (such as cerebral thrombosis, transientischemic attack, myocardial infarction, peripheral arterial disease, etc.); Patientswith a history or complications of venous thrombosis (such as deep vein thrombosis,pulmonary embolism); or patients who are using anticoagulants or antiplatelet drugsat the beginning of screening.

  4. Subjects who have used romiplostim or its analogs in the past and have notresponded.

  5. Subjects who have used eltrombopag, haitubopag, avatubopag, recombinant humanthrombopoietin (rhTPO), or other drugs with c-MPl stimulating effects within the 4weeks prior to signing the ICF.

  6. Received any anti-malignancy agents (e.g., cyclophosphamide, mercaptopurine,vincristine, vinblastine, interferon-alfa) within 8 weeks prior to signing the ICF.

  7. Less than 4 weeks since end of any clinical trials about therapeutic drug or deviceprior to signing the ICF.

  8. Laboratory abnormalities with clinical significance at screening visit.

  9. In the opinions of investigators, the patients are not suitable for participation inthis trial.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: PN20 treatment
Phase: 1
Study Start date:
March 07, 2025
Estimated Completion Date:
October 28, 2025

Study Description

This is a multicenter, open-label, single-arm, dose-escalation Phase1b study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of a single dose of PN20 in adult patients with primary immune thrombocytopenia (ITP).

The trial is a dose escalation study, including Screening (no more than 14 days), Treatment (single dose) and the post-treatment follow-up (4 weeks).

And the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of PN20 in ITP will be assessed in this study.

Connect with a study center

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550004
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Jining First People's Hospital

    Jining, Shandong 272011
    China

    Active - Recruiting

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin 301609
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650000
    China

    Active - Recruiting

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