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

Phase 2

Active, not recruiting

• Conditions: Primary Immune Thrombocytopenia
• Interventions: Biological: CM313 injection; Other: placebo

• Registration Number: NCT06594146
• Lead Sponsor: Keymed Biosciences Co.Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Study Start: 2024-11-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1	CM313 injection	CM313 injection and placebo
Group 1	placebo	CM313 injection and placebo
Group 2	CM313 injection	CM313 injection and placebo
Group 2	placebo	CM313 injection and placebo
Group 3	CM313 injection	CM313 injection and placebo
Group 3	placebo	CM313 injection and placebo

Primary Outcome Measures

Name	Time	Method
Adverse event	Up to Week 16	Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China