NCT06930612

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

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
4mo left

Started May 2025

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Progress73%
May 2025Sep 2026

First Submitted

Initial submission to the registry

April 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

  • Nasal Polyps Score (NPS)

    Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

    at week 24

Study Arms (4)

CM512 Dose 1

EXPERIMENTAL
Biological: CM512

CM512 Dose 2

EXPERIMENTAL
Biological: CM512

CM512 Dose 3

EXPERIMENTAL
Biological: CM512

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CM512BIOLOGICAL

Administered subcutaneous injection

CM512 Dose 1CM512 Dose 2CM512 Dose 3
PlaceboDRUG

Administered subcutaneous injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • with chronic rhinosinusitis with nasal polyposis (CRSwNP).
  • Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
  • Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.
  • Contraception.

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.
  • Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tong-Ren hospital

Beijing, China

Location

Study Officials

  • Luo Zhang

    Beijing Tong-Ren hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620qianjia@keymedbio.com

Study Design

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

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 16, 2025

Study Start

May 16, 2025

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations

CN(1)