AzTrials
AzTrials

Chronic Rhinosinusitis (Diagnosis)Phase 2NCT04805398

Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)

A Phase 2 study testing CM310 in people with Chronic Rhinosinusitis (Diagnosis) and Nasal Polyps, run by Keymed Biosciences Co.Ltd at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CM310
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
19 sitesChina
Study dates
6 Apr 2021to 18 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bilateral CRSwNP.
  • Prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps.
  • Stable dose of intranasal corticosteroids for at least 4 weeks before screening.
  • Ongoing symptoms for at least 4 weeks before screening：1)Nasal congestion/obstruction; 2)Othe symptom, e.g., loss of smell or rhinorrhea.
  • Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
  • NCS score of 2 or 3 at screening and at baseline.
  • Eosinophilic level meets the one of the following criteria: 1) serum eosinophil count ≥6.9% (without concomitant asthma) or ≥3.7% (with concomitant asthma) at screening; 2) absolute count of ≥55 per high power field or percentage of ≥27% in eosinophil level from nasal polyps biospy tissue.
  • Contraception.

Who cannot join

  • Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
  • concurrent disease, e.g., ongoing rhinitis medicamentosa, acute sinusitis, nasal infection or upper respiratory infection, allergic fungal rhinosinusitis, malignancy, uncontrolled chronic disease such as cardivascular diseases, tuberculosis, diabetes etc.
  • Allergic or intolerant to mometasone furoate spray or CM310/placebo.
  • Significant liver or renal dysfunction.
  • Other.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing Chaoyang Hospital, CMU

    Beijing, Beijing Municipality

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Beijing Renmin Hospital

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing Municipality

  • Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Shandong Second Provincial General Hospital (Shandong ENT hospital)

    Jinan, Shangdong

  • Jingzhou Central Hospital

    Jingzhou, Hubei

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Renji Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

Other trials in China

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, PK, PD and Immunogenicity of Subcutaneously Given Multiple-Dose CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Read the detailed description

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks, till End-of-Treatment Visit) and a Safety Follow-up Period (8 weeks, till End-of-Study Visit).

56 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All patients will receive MFNS on a daily basis as a background treatment throughout the study. MFNS is required to use no less than 14 days during Screening/run-in Period.

Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Being tested
CM310, Placebo
Keywords
Chronic Rhinosinusitis with Nasal Polyps
Medical subject headings
Disease, Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM310Biological

    300 mg every two weeks

  • PlaceboBiological

    300 mg every two weeks

Study groups in NCT04805398
Study groupRoleWhat they receive
CM310ExperimentalCM310 300mg is given subcutaneously (SC) every two weeks for 16-week treatment
Receives: Biological: CM310
PlaceboPlacebo comparatorPlacebo is given subcutaneously (SC) every two weeks for 16-week treatment.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bilateral endoscopic Nasal Polyps Score (NPS)

    Change from baseline in the bilateral endoscopic NPS.NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

    Measured: at Week 16

  2. Nasal Congestion/Obstruction SymptomSeverity (NCS) Score

    Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.

    Measured: at Week 16

Secondary outcomes (16)

  1. Time to the first response of NPS

    Time to the first response of NPS (defined as bilateral endoscopic NPS improved ≥1).

    Measured: Baseline up to Week 24

  2. Lund-Mackay score

    Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse nasosinusitis.

    Measured: at Week 16

  3. Volume of the involved area of nasosinusitis on 3D-construction CT scan

    Change from baseline in the volume of the involved area of nasosinusitis on 3D-construction CT scan.

    Measured: at Week 16

  4. Bilateral endoscopic NPS

    Change from baseline in the bilateral endoscopic NPS.

    Measured: at Week 8

  5. Proportion of subjects receiving rescue therapy for nasal polyps

    Proportion of subjects receiving rescue therapy for nasal polyps.

    Measured: Baseline up to Week 24

  6. University of Pennsylvania Smell Identification Test (UPSIT)

    Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.

    Measured: at Week 16

  7. 22-item Sino-nasal Outcome Test Scores(SNOT-22) score

    Change from baseline in SNOT-22 score. SNOT-22 score (0-110). Higher score means a worse outcome.

    Measured: at Week 16

  8. Total Symptom Score(TSS) score

    Change from baseline in TSS score. TSS score (0-9). Higher score means worse nasal symptom.

    Measured: at Week 16

  9. Bilateral endoscopic NPS

    Change from baseline in the bilateral endoscopic NPS in subjects with concurrent asthma.

    Measured: at Week 16

  10. Bilateral endoscopic NCS

    Change from baseline in the NCS in subjects with concurrent asthma.

    Measured: at Week 16

  11. Safety parameters

    Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.

    Measured: Baseline up to Week 24

  12. Pharmacokinetics(PK)

    Trough concentration and exposure.

    Measured: Baseline up to Week 24

  13. Pharmacodynamics(PD)

    Change from baseline in serum biomarker level (TARC, total IgE and eosinophil level).

    Measured: Baseline up to Week 24

  14. PD(eosinophil level in nasal polyps biospy tissue)

    Change from baseline of eosinophil level in nasal polyps biospy tissue.

    Measured: at Week 16

  15. Anti-drug antibodies(ADA)

    Incidence of ADA.

    Measured: Baseline up to Week 24

  16. Neutralizing antibody (Nab)

    Incidence of Nab.

    Measured: Baseline up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start6 Apr 2021
  3. Primary completion18 Mar 2022
  4. Study completion18 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805398
Sponsor's protocol ID
CM310NP001
Status last verified
Nov 2021
First submitted
12 Mar 2021
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Yan B, Shen S, Song X, Jiang Y, Shi L, Zhao C, Yang Y, Jiang L, Li J, Ye J, Liu J, Wan L, Yang Y, Chen J, Liu F, Su L, Xu Y, Tan G, Yu S, Zhang Y, Wang L, Liu S, Yan H, Liu W, Chen B, Wang C, Zhang L. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. EClinicalMedicine. 2023 Jul 5;61:102076. doi: 10.1016/j.eclinm.2023.102076. eCollection 2023 Jul.

    PubMed 37483544

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CM310 in people with Chronic Rhinosinusitis (Diagnosis) and Nasal Polyps, run by Keymed Biosciences Co.Ltd at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bilateral endoscopic Nasal Polyps Score (NPS) (time frame: at Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in