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Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Initial Efficacy of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia

NCT06594146•Keymed Biosciences Co.Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years old ≤ 75 years old, male or female.
•Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form.

Exclusion Criteria

•Previously received allogeneic stem cell transplantation or organ transplantation.
•Laboratory abnormalities with clinical significance at screening visit.
•Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period.
•With any other situations that are not suitable for participation in this study by the investigator.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Key Dates

Start Date

November 11, 2024

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

April 23, 2025

Enrollment

ACTUAL participants

Conditions

Primary Immune Thrombocytopenia

Interventions

CM313 injection

BIOLOGICAL

placebo

OTHER

Safety Study of CC312 in Autoimmune Disease Patients

NCT06888960

Systemic Lupus Erythematosus (SLE)Idiopathic Inflammatory Myopathy (IIM)+4 more

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COMPLETEDPHASE2

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

NCT04278924

Primary Immune Thrombocytopenia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

Inclusion Criteria

Exclusion Criteria

Safety Study of CC312 in Autoimmune Disease Patients

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA