AzTrials
AzTrials

Chronic Rhinosinusitis With Nasal PolypsPhase 2NCT06015243

The Study of Long-term Outcomes 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..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps Read more about this study

Who is it for?
Ages 18 years and older
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?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
18 Aug 2023to 30 Mar 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participation in a clinical study of GR1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the W16 visit.
  • the investigator judges that the subject may benefit from continued use of the test drug.
  • Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form

Who cannot join

  • Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial;
  • Use of any protocol-specified prohibited medication/treatment during the GR1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable.
  • The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit;
  • Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall;
  • Individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial;
  • Any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the GR1802-005 study period for which, in the judgment of the Principal Investigator, the subject is considered unsuitable for participation in the trial;
  • Other.

About this study

Official title: An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps

Read the detailed description

This trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.

Being tested
GR1802 injection

What participants receive

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

  • GR1802 injectionDrug

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

Study groups in NCT06015243
Study groupRoleWhat they receive
Experimental: GR1802ExperimentalGR1802 injection 300mg every two weeks for 16-week treatment
Receives: Drug: GR1802 injection

What is being measured

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

  1. Adverse events

    to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.

    Measured: Baseline up to Week 24

Secondary outcomes (10)

  1. Change From Baseline at each evaluation time point 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: Baseline up to Week 24

  2. Change From Baseline at each evaluation time 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: Baseline up to Week 24

  3. Total Nasal Symptom Score(TNSS) score

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

    Measured: Baseline up to Week 24

  4. University of Pennsylvania Smell Identification Test (UPSIT)

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

    Measured: Baseline up to Week 24

  5. Visual Analogue Scale (VAS) for Rhinosinusitis

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

    Measured: Baseline up to Week 24

  6. Proportion of subjects receiving rescue therapy for nasal polyps

    Rescue therapy includes Systemic Corticosteroids and endoscopic surgery

    Measured: Baseline up to Week 24

  7. Ctrough

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

    Measured: Baseline up to Week 24

  8. Vz/F

    PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.

    Measured: Baseline up to Week 24

  9. CL/F

    PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.

    Measured: Baseline up to Week 24

  10. Anti-drug antibodies(ADA)

    Incidence of ADA

    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 posted29 Aug 2023
  2. Study start18 Aug 2023 (estimated)
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Mar 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015243
Sponsor's protocol ID
GR1802-010
Status last verified
Aug 2023
First submitted
15 Aug 2023
Last updated
29 Aug 2023
Results posted
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..

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 3 inclusion and 7 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 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?

Adverse events (time frame: Baseline up to Week 24). 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 NCT06015243.

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 Aug 2023.

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