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Tests treatment safety and results for Chronic Rhinosinusitis With Nasal Polyps
Official title Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
ClinicalTrials.gov ID: NCT07132827
What this study is testing
What is SHR-1905 Injection?
SHR-1905 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic rhinosinusitis with nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Weight ≥40kg
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
- NCS ≥2 at screening and baseline.
- SNOT-22≥30 at screening period and baseline.
You likely can't join if
- Any comorbidities that may affect the how well it works evaluation of nasal polyps.
- Any comorbidities except for asthma that may affect blood EOS levels.
- Concomitant with immunodeficiency.
- Concomitant with contraindications or not suitable for nasal endoscopy.
- Uncontrolled hypertension and/or uncontrolled diabetes.
- Concomitant with infection within 4 weeks prior to randomization.
See the full eligibility criteria
- Weight ≥40kg
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
- NCS ≥2 at screening and baseline.
- SNOT-22≥30 at screening period and baseline.
- Recorded persistent NP symptoms for over 4 weeks prior to screening.
- people received standard therapy with intranasal corticosteroids (INCS) prior to randomization.
- NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances).
- Any comorbidities that may affect the how well it works evaluation of nasal polyps.
- Any comorbidities except for asthma that may affect blood EOS levels.
- Concomitant with immunodeficiency.
- Concomitant with contraindications or not suitable for nasal endoscopy.
- Uncontrolled hypertension and/or uncontrolled diabetes.
- Concomitant with infection within 4 weeks prior to randomization.
- Uncontrolled epistaxis within 4 weeks prior to randomization.
- Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
- Parasitic infection within 6 months before randomization.
- Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
- Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
- Abnormalities of laboratory tests at screening or baseline.
- Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
- Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to people.
- FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
- Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
- SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
- Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
- Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
- Allergen immunotherapy within 8 weeks before randomization.
- Smoking at screening, or smoking cessation less than 6 months at screening.
- Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization. Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.