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Chronic Rhinosinusitis with Nasal PolypsPhase 2NCT05873803

The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps

A Phase 2 study testing GR1802 injection in people with Chronic Rhinosinusitis with Nasal Polyps, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Rhinosinusitis with Nasal Polyps
What is being tested?
GR1802 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteChina
Study dates
8 Feb 2023to 30 Dec 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps
  • Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
  • Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).
  • Recorded use of intranasal corticosteroids for at least 4 weeks before screening

Who cannot join

  • Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。
  • Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.
  • Other.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety of GR1802 Injection 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 GR1802 injection 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). Patients will receive GR1802 injection or Placebo every 2 Weeks.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.

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

70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.

Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Being tested
GR1802 injection, placebo

What participants receive

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

  • GR1802 injectionBiological

    150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

  • placeboBiological

    0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Study groups in NCT05873803
Study groupRoleWhat they receive
Experimental: GR1802ExperimentalGR1802 injection 300mg every two weeks for 16-week treatment
Receives: Biological: GR1802 injection
Placebo Comparator: PlaceboPlacebo comparatorPlacebo 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. Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score

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

    Measured: at Week 16

  2. Change From Baseline at Week 16 in Nasal Polyp Score

    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 (12)

  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 rhinosinusitis.

    Measured: at Week 16

  3. Bilateral endoscopic NPS

    Change from baseline in the bilateral endoscopic NPS at Week 4, 8, 12, 24.

    Measured: at Week 4, 8, 12, 24

  4. Nasal Congestion/Obstruction Symptom score(NCS)

    Change from baseline in NCS at Week 4, 8, 12, 24.

    Measured: at Week 4, 8, 12, 24

  5. 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

  6. Total Nasal Symptom Score(TNSS) score

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

    Measured: at Week 16

  7. Visual Analogue Scale (VAS) for Rhinosinusitis

    Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.

    Measured: at Week 16

  8. Proportion of subjects receiving rescue therapy for nasal polyps

    Rescue therapy includes Systemic Corticosteroids and endoscopic surgery

    Measured: Baseline up to Week 24

  9. Pharmacokinetics(PK)

    Plasma concentration of GR1802 injection. PK parameter including trough concentration and exposure（CL/F, Vz/F etc.）

    Measured: Baseline up to Week 24

  10. Pharmacodynamics(PD)

    Change from baseline in serum biomarker level (Periostin, TARC, total IgE and eosinophil level) and biomarkers in nasal secretions and nasal exfoliated cells。

    Measured: at Week 16

  11. Anti-drug antibodies(ADA)

    Incidence of ADA

    Measured: Baseline up to Week 24

  12. Safety parameters

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

    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 posted24 May 2023
  2. Study start8 Feb 2023
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05873803
Sponsor's protocol ID
GR1802-005
Status last verified
Jun 2024
First submitted
16 May 2023
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GR1802 injection in people with Chronic Rhinosinusitis with Nasal Polyps, run by Genrix (Shanghai) Biopharmaceutical 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 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. 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?

Results are not available in the source record.

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?

Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score (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 NCT05873803.

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 25 Sep 2024.

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