NCT07519577

Brief Summary

This is an open-label, single-arm, multicenter, extension study to evaluate the safety and efficacy of CM512 in patients With Chronic Rhinosinusitis with Nasal Polyposis

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
22mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress9%
May 2026May 2028

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

April 2, 2026

Last Update Submit

June 26, 2026

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    Incidences of adverse events

    Up to week 60

Study Arms (1)

CM512

EXPERIMENTAL
Biological: CM512

Interventions

CM512BIOLOGICAL

Administered subcutaneous injection

CM512

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in the clinical study of CM512 in patients with Chronic Rhinosinusitis with Nasal Polyposis (Study No. of CM512-102101) .

You may not qualify if:

  • Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
  • Administration of a live attenuated vaccine within 30 days prior to baseline or planning to receive one during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tong-Ren hospital

Beijing, China

Location

Central Study Contacts

Qian Jia

CONTACT

028-88610620clinicaltrial@keymedbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

May 31, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations

CN(1)