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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM313 injection

Biological

CM313

Placebo

Other

placebo

Primary outcomes

Adverse event

Time frame: Up to Week 16

Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2024
Registry last updated: Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting