NCT06594146

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

September 10, 2024

Last Update Submit

April 18, 2025

Conditions

Primary Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Adverse event

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

    Up to Week 16

Study Arms (3)

Group 1

EXPERIMENTAL

CM313 injection and placebo

Biological: CM313 injectionOther: placebo

Group 2

EXPERIMENTAL

CM313 injection and placebo

Biological: CM313 injectionOther: placebo

Group 3

EXPERIMENTAL

CM313 injection and placebo

Biological: CM313 injectionOther: placebo

Interventions

CM313 injectionBIOLOGICAL

CM313

Group 1Group 2Group 3
placeboOTHER

placebo

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Lei Zhang

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

November 11, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations

CN(1)