A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps

Genrix (Shanghai) Biopharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Placebo; Drug: GR1802

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516302

GR1802-007

Details and patient eligibility

About

The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are:

1. Does GR1802 reduce the need for surgery and systemic corticosteroid use？
2. What medical problems do participants have when taking GR1802?

Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP.

Participants will:

Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.

Full description

A randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. The clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , maintenance treatment period and safety follow-up period.

The clinical trial aimed to evaluate the efficacy, safety and immunogenicity of GR1802 injection in CRSwNP participants.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as CRSwNP and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening.
• An endoscopic bilateral NPS at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity).
• Nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) .
• Willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol.

Exclusion criteria

• Biologic therapy within 5 half-lives or within 10 weeks before baseline.
• Anti-IL-4Rα antibody before screening.
• An experimental drug within 5 half-lives or 1 months before baseline.
• Systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline.
• Initiation of allergen immunotherapy within 3 months before screening.
• Participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days.
• Participants with FEV1 50% or less of predicted normal were excluded.
• Participants who have undergone any intranasal and/or sinus surgery within 6 months before screening.
• Acute sinusitis or upper respiratory infection within a defined time period before screening.
• A nasal cavity tumor (malignant or benign).
• Evidence of fungal rhinosinusitis.
• Presence of another diagnosis associated with nasal polyps (i.e., eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, cystic fibrosis).
• Rhinitis medicamentosa.
• Nasal septal deviation occluding at least one nostril.
• Antrochoanal polyps.
• Pregnant or lactating woman.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

GR1802 group

Experimental group

Description:

GR1802 300mg is administrated every 2 weeks (first dose doubled) for a total of 26 doses, of which an additional 2 ml of placebo is given at week 24.

Treatment:

Drug: GR1802

placebo group

Placebo Comparator group

Description:

Placebo is administered every 2 weeks for the first 16 weeks. GR1802 is given every 2 weeks from week 24 to W50.

Treatment:

Drug: Placebo