GB001 in Adult Subjects with Chronic Rhinosinusitis
- Conditions
- Chronic Rhinosinusitis with or without Nasal PolypsMedDRA version: 21.1Level: PTClassification code 10071399Term: Chronic eosinophilic rhinosinusitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-001682-33-CZ
- Lead Sponsor
- GB001, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Age: = 18 to 75 years of age at the time of Screening visit.
3. Sex: Males or females:
a. Women of childbearing potential (WOCBP) must use an acceptable method of contraception at least 1 month prior to screening through 28 days after the last dose of IP.
4. Diagnosis: Diagnosis of chronic rhinosinusitis with or without bilateral nasal polyps for at least 12 weeks prior to Visit 1.
5. Nasal symptoms: Presence of at least two of the following symptoms prior to Visit 1:
• nasal blockade/obstruction/congestion
• nasal discharge (anterior/posterior nasal drip)
• facial pain/pressure
• preduction or loss of smell
6. INCS: Subjects must be on a stable administration of intranasal corticosteroids (INCS) for = 2 months prior to Visit 1. For subjects using a specialized delivery device (eg, XHANCE™) or corticosteroids administered via irrigation (eg, budesonide + sterile saline), they must be on MFNS for = 2 weeks prior to screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Nasal symptoms: SNOT-22 score <20 as assessed at screening. 2.Prior polyp surgery: Subjects who have undergone any nasal surgery (excluding polypectomy performed as an outpatient procedure) within 4 months before screening or have had =4 sinonasal surgeries in the past. 3.Comorbidities: Presence of a known pre-existing clinically important condition including: active tuberculosis, pulmonary fibrosis, bronchopulmonary aspergillosis, eosinophilic granulomatous polyangiitis (Churg-Strauss syndrome), Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, and cystic fibrosis.Clinically significant endocrine, autoimmune, metabolic, neurological, renal (calculated creatinine clearance <60 mL/min), gastrointestinal, hepatic, cardiovascular, hematological, or any other system abnormalities that are uncontrolled with standard treatment. 4.Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to screening (subjects will not be excluded if they had localized carcinoma of the skin that was resected for cure). 5.Liver Disease: Known pre-existing liver disorders (ie, non-alcoholic fatty liver disease (NALFD) or Gilbert's syndrome),or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, or known biliary abnormalities. 6.Prior anti-inflammatory treatment: Subjects who have required a burst of systemic corticosteroids (eg, oral, intravenous, intramuscular corticosteroids) within the 1 month before screening or are scheduled to receive systemic corticosteroids during the study period for another condition, or who have required intranasal corticosteroid drops within 1 month prior to screening.
7.Intolerant to mometasone furoate nasal spray. 8.Specific conditions/concomitant diseases: Subjects with conditions such as: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril; acute sinusitis, invasive fungal rhinosinusitis, neutrophilic polyposis, nasal infection or upper respiratory infection at screening or in the 2 weeks before screening. Subjects requiring chronic systemic antibiotic treatment for rhinosinusitis. 9.Ongoing rhinitis medicamentosa. 10.ECG Assessment: Subjects with QTcF =450 msec for males or QTcF =470 msec for females on the Screening visit ECG. However, if QTcF is above this prespecified limit and there are no other clinically significant ECG abnormalities in the opinion of the Investigator, the assessment can be repeated in triplicate. The triplicate QTcF values should be averaged by the Investigator to determine eligibility of the subject to enter the Run-in period. However, if any of the triplicate ECGs show a clinically significant abnormality in the opinion of the Investigator, the subject should be excluded, regardless of the average QTcF of the triplicates. 11.Alcohol/Marijuana/Illicit Drugs/Substance Abuse: A known or suspected history of alcohol misuse, marijuana, illicit drugs, or substance abuse within 12 months prior to Screening visit. 12.Smoking history: Asthma or COPD patients that are current smokers (any substance), or former smokers with a smoking history of =10 pack-years [(number of cigarettes per day/20) × number of years smoked]. A former smoker is defined as a subject who quit smoking at least 6 months prior to Screening visit. This includes electronic cigarettes and vaping. 13.Immunodeficiency: A
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the effect of GB001 on the Sino-Nasal Outcome Test-22 (SNOT-22);Secondary Objective: • To evaluate the effect of GB001 on reducing opacification of the sinuses as measured by CT scan<br>• To evaluate the effect of GB001 in the treatment of bilateral NP by assessment of the endoscopic nasal polyp score (NPS) in a subset of patients with nasal polyps<br>• To evaluate the effect of GB001 in improving patient reported symptoms<br>• To evaluate the effect of GB001 in improving sense of smell (University of Pennsylvania Smell Identification Test, UPSIT)<br>• To evaluate the effect of GB001 on chronic rhinosinusitis (CRS) exacerbation<br>• To evaluate the safety and tolerability of GB001 compared with placebo;Primary end point(s): • Change from baseline to Week 16 in SNOT-22;Timepoint(s) of evaluation of this end point: Week 16<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change from baseline to Week 16 in opacification of sinuses as measured by Lund-Mackay score on CT scan<br>• Change from baseline to Week 16 in NPS<br>• Time to first response (= 1 point improvement from baseline) in NPS<br>• Change from baseline to Week 16 in nasal congestion (NC)<br>• Change from baseline to Week 16 in total symptom score (TSS)<br>• Change from baseline to Week 16 in UPSIT<br>• Time to first CRS exacerbation, defined as deterioration of CRS symptoms requiring treatment with an antibiotic, an anti-inflammatory drug, or a symptom reliever; an Emergency Department visit; or hospitalization<br>• Incidence of treatment-emergent adverse events (TEAEs)<br>• Change from baseline in laboratory, electrocardiogram (ECG), and vital signs parameters;Timepoint(s) of evaluation of this end point: 1. Week 16<br>2. Screening period and weeks 0, 2, 4, 8, 12, 16, Early Withdrawal from Study, Early Discontinuation of IP, week 20