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

April 18, 2025 updated by: Keymed Biosciences Co.Ltd

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
CM313 injection and placebo
Other: placebo
placebo
Biological: CM313 injection
CM313
Experimental: Group 2
CM313 injection and placebo
Other: placebo
placebo
Biological: CM313 injection
CM313
Experimental: Group 3
CM313 injection and placebo
Other: placebo
placebo
Biological: CM313 injection
CM313

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: Up to Week 16
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Lei Zhang, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM313-111101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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