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Chronic Rhinosinusitis With Nasal PolypsPhase 1/2DUBHENCT05324137

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

A Phase 1/2 study testing CM326 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Keymed Biosciences Co.Ltd at 1 site in China.

Completed

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

Official record
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Trial summary

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Rhinosinusitis With Nasal Polyps
What is being tested?
CM326
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteChina
Study dates
11 Jul 2022to 29 Mar 2024
Phase
Phase 1/2
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

  • Subjects who are capable of understanding the nature of the study and voluntarily signing the ICF.
  • Male or female subjects, aged between 18 and 70 years old (inclusive), with a body mass index (BMI) ≥ 19 kg/m2.
  • Diagnosed with Chronic Rhinosinusitis With Nasal Polyps.
  • The total NPS score should be at least 3 points, with at least 1 point in each side of the nasal cavity.
  • Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.
  • Ongoing symptoms for at least 4 weeks before screening：1) Nasal congestion/obstruction; 2) Other symptom, e.g., loss of smell or rhinorrhea.

Who cannot join

  • Allergic or intolerant to mometasone furoate spray or CM326/placebo.
  • Have used of systemic immunosuppressants for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to randomization.
  • Have initiated leukotriene receptor antagonist therapy within 4 weeks prior to randomization.
  • have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
  • Have undergone nasal surgery (including nasal polypectomy) within 6 months prior to screening.
  • Have received medium- and short-acting systemic corticosteroids (including oral, intravenous, intramuscular corticosteroids), nasal dripping corticosteroids, traditional Chinese medicine (including systemic and local herbal products preparations) for chronic rhinosinusitis (CRS) within 4 weeks prior to screening, or long-acting systemic corticosteroids.
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  • With concomitant asthma (including suspected diagnosis of asthma) will be excluded if they meet the following conditions: predicted FEV1 of≤ 60%, or acute exacerbation of asthma within 3 months prior to screening requiring SCS or hospitalization (> 24 hours), or using inhaled corticosteroids (ICS) of > 1000 μg fluticasone propionate or others at equivalent doses
  • With antrochoanal polyps.
  • With severe deviation of the nasal septum occludes at least one nostril.
  • With persistent rhinitis medicamentosas.
  • With allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, cystic fibrosis.
  • With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
  • Have symptoms or whose CT scan suggests allergic fungal sinusitis.
  • With malignant or benign neoplasm of nasal cavities.
  • With other uncontrolled serious diseases or recurrent chronic diseases.
  • Have severe hepatic and renal impairment.
  • Have received live attenuated vaccines within 12 weeks prior to randomization, or during the planned study; or have received inactivated vaccines (e.g., novel coronavirus vaccines) within 30 days prior to randomization.
  • With known or suspected immunosuppression, including, but not limited to, the history of invasive opportunistic infections.
  • Subjects who are pregnant or planning to become pregnant, or breastfeeding during the study.
  • With a history of large alcohol consumption or a history of drug abuse within 3 months prior to screening.
  • With other medical or non-medical conditions that are not suitable for participation in the study in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

Read the detailed description

The study consists of 3 periods, a Screening Period, a Treatment Period and a Safety Follow-up Period.

Subjects who meet eligibility criteria will be randomized to receive either CM326 or placebo subcutaneously.

Being tested
CM326, Placebo

What participants receive

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

  • CM326Drug

    CM326 injection

  • PlaceboOther

    Placebo

Study groups in NCT05324137
Study groupRoleWhat they receive
Group 1: 55mg Q2WExperimentalCM326 55 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Receives: Drug: CM326; Other: Placebo
Group 2: 110mg Q2WExperimentalCM326 110 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Receives: Drug: CM326; Other: Placebo
Group 3: 220mg Q2WExperimentalCM326 220 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Receives: Drug: CM326; Other: Placebo
Group 4: 220mg Q4WExperimentalCM326 220mg or matched placebo, every 4 weeks, subcutaneous (SC)
Receives: Drug: CM326; Other: Placebo

What is being measured

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

  1. Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

    Measured: up to Week 64

  2. Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16.

    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

Secondary outcomes (10)

  1. PK: Concentration of CM326 in plasma

    Concentration of CM326 in plasma

    Measured: up to Week 64

  2. Immunogenicity: anti-drug antibody (ADA)

    Occurrence of positive anti-drug antibody (ADA)

    Measured: up to Week 64

  3. PD: Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration.

    Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration.

    Measured: up to Week 64

  4. PD: Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration.

    Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration.

    Measured: up to Week 64

  5. PD: Changes from baseline in plasma interleukin-5 (IL-5) after CM326 administration

    Changes from baseline in plasma interleukin-5 (IL-5) after CM326 administration

    Measured: up to Week 64

  6. PD: Changes from baseline in plasma interleukin-13 (IL-13) after CM326 administration

    Changes from baseline in plasma interleukin-13 (IL-13) after CM326 administration

    Measured: up to Week 64

  7. PD: Changes from baseline in serum periostin after CM326 administration

    Changes from baseline in serum periostin after CM326 administration

    Measured: up to Week 64

  8. PD: Changes from baseline in blood eosinophilic level after CM326 administration

    Changes from baseline in blood eosinophil level after CM326 administration

    Measured: up to Week 64

  9. PD: Changes from baseline in eosinophilic level of nasal polyp biopsy tissue after CM326 administration

    Changes from baseline in eosinophil level of Nasal polyp biopsy tissue after CM326 administration

    Measured: up to Week 64

  10. Efficacy: changes from baseline of nasal polyp score (NPS) in non-eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP)

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

    Measured: up to Week 64

Timeline

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

  1. First posted12 Apr 2022
  2. Study start11 Jul 2022
  3. Primary completion29 Mar 2024
  4. Study completion29 Mar 2024

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324137
Sponsor's protocol ID
CM326NP001
Acronym
DUBHE
Status last verified
Mar 2024
First submitted
18 Mar 2022
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xian M, Lan F, Yan B, Shen S, Liu S, Wan L, Song X, Jiang L, Jiang Y, Xue J, Chen J, Su L, Ye J, Yang Y, Fang H, Tan G, Zhang Q, Qu S, Wei X, Luo X, Xu Y, Yu S, Xiao Z, Liu F, Li Q, Zhang Y, Xie Y, Wang L, Yang G, Yan H, Zhao G, Chen B, Wang C, Zhang L. An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial. Nat Commun. 2025 Sep 29;16(1):8607. doi: 10.1038/s41467-025-63682-x.

    PubMed 41022848

  • Shen S, Xian M, Yan B, Lan F, Wang C, Zhang L. Anti-thymic stromal lymphopoietin monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps (DUBHE): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled study. Asia Pac Allergy. 2024 Mar;14(1):26-31. doi: 10.5415/apallergy.0000000000000135. Epub 2024 Jan 25.

    PubMed 38482462

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CM326 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Keymed Biosciences Co.Ltd at 1 site 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 6 inclusion and 21 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. (time frame: up to Week 64). 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 NCT05324137, which also lists 2 linked publications.

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 8 Nov 2024.

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