A Phase 2 interventional study of GR1802 injection in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 2, Interventional, and Treatment
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
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.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GR1802 injection 300mg every two weeks for 16-week treatment
Drug: GR1802 injection
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Adverse events
to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.
Time frame: Baseline up to Week 24
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.
Time frame: Baseline up to Week 24
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.
Time frame: Baseline up to Week 24
Total Nasal Symptom Score(TNSS) score
Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
Time frame: Baseline up to Week 24
University of Pennsylvania Smell Identification Test (UPSIT)
Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
Time frame: Baseline up to Week 24
Visual Analogue Scale (VAS) for Rhinosinusitis
Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
Time frame: Baseline up to Week 24
Proportion of subjects receiving rescue therapy for nasal polyps
Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
Time frame: Baseline up to Week 24
Ctrough
PK parameter: trough concentration of GR1802 injection. and exposure（CL/F, Vz/F etc.）
Time frame: Baseline up to Week 24
Vz/F
PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.
Time frame: Baseline up to Week 24
CL/F
PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.
Time frame: Baseline up to Week 24
Anti-drug antibodies(ADA)
Incidence of ADA
Time frame: Baseline up to Week 24
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Telikibart
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