A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps

Female and male patients aged > 18 and < 75 years at the time of screening.

Patients who are diagnosed with chronic rhinosinusitis with bilateral polyps despite treatment with systemic corticosteroid within the past 2 years and/or medical contraindication/intolerance to systemic corticosteroids. The polyps have a minimum bilateral NPS of 5 out of a maximum score of 8 with at least a score of 2 for each nostril at screening and baseline evaluated by endoscopy (assessed by independent central readers).

Nasal congestion/blockade/obstruction with moderate or severe symptom severity (Nasal Congestion Score of > 2) at screening and a weekly average severity of > 1 at time of randomization.

Patients using nasal mometasone at least 200 mcg per day, or equivalent daily dosing of another INCS, for at least 28 days before randomization, and willing to continue for the duration of the study. Note: For patients who are using an alternative INCS product other than MFNS prior to the screening visit, the investigator must switch the patient to MFNS at V1.

Patients willing to enter eDiary daily symptom assessments and maintain stable dosing with MFNS with a compliance of at least 70% in the 7 days preceding randomization. Note: Patients must use nasal mometasone at least 200 mcg/day, or equivalent, for at least 28 days before randomization, which can include days prior to screening with supportive documentation. Run-in can be 7-31 days with the compliance determined in the week prior to dosing.

Male patients who are nonsterilized and sexually active with a female partner of childbearing potential agree to use highly effective contraception from randomization until 8 weeks after last dose.

Female patients of childbearing potential who are sexually active with a nonsterilized male partner should have a confirmed negative serum beta-human chorionic gonadotropin test at Visit 1 and agrees to use highly effective contraception from signing of informed consent throughout the duration of the study and for 8 weeks after last dose.

Patient able to read and understand and willing to sign the informed consent form (ICF) prior to any study related procedures being performed.

Willing and able to comply with study visits and study-related procedures, in the opinion of the Investigator.

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 146

F.1.3 Elderly (>=65 years) yes

F.1.3.1 Number of subjects for this age range 1

Patients unable to use MFNS.

Patients who are taking or have taken the following prohibited therapies as specified:

a. Systemic steroids within 28 days prior to screening

b. Other nonbiologic investigational drugs within 60 days (or 5 half-lives, whichever is longer) of screening

c. Intranasal corticosteroid drops or CS-administering devices within 28 days prior to screening

d. Non-steroidal immunosuppressants within 60 days or 5 half-lives, whichever is longer, of screening

e. Any monoclonal antibody therapy or investigational biologic drug for asthma or other diseases within 60 days or 5 half-lives, whichever is longer, of screening

f. Leukotriene antagonists/modifiers within 7 days prior to screening for patients who were not on continuous treatment for = 30 days prior to screening.

g. Allergen immunotherapy for patients who were not on maintenance treatment for at least 90 days prior to screening.

Patients who did not respond favorably to previous dupilumab treatment.

Patients who have undergone any nasal surgery within 6 months before screening; or have a history of sinus or nasal surgery modifying the structure of the nose such that assessment of NPS is not possible, or have had uncontrolled epistaxis requiring surgical or procedural intervention, including nasal packing.

Patients with conditions/concomitant diseases making them non evaluable at screening or for the primary efficacy endpoint.

Signs or a CT scan suggestive of Allergic Fungal Rhinosinusitis.

Patients with co-morbid asthma are excluded if:

a. FEV1 = 50% of normal predicted value.

OR

b. An exacerbation within 90 days prior screening that required hospitalization (> 24 hours).

OR

c. Are on a daily dose of inhaled corticosteroids (ICS) higher than 1000 mcg fluticasone or the equivalent.

Known or suspected history of immunosuppression, including history of invasive opportunistic infections. Tuberculosis testing would be performed on a country by country basis according to local guidelines if required by regulatory authorities or ethics committees.

Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) or hepatitis C (HCV) antibody; or positive HIV serology.

A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent that has not been treated with, or has failed to respond to, standard of care therapy

Evidence of infection requiring treatment with systemic antibacterials, antivirals, antifungals, antiparasitics, or antiprotozoals within 7 days before baseline, or significant viral infections within 14 days before screening that may not have received antiviral treatment.

Live, attenuated vaccinations within 28 days prior to screening or planned live, attenuated vaccinations during the study.

Pregnant or intent to become pregnant during the study, or breast-feeding women.

Any disorder or major physical impairment that is not stable in the opinion of the investigator and may affect the safety of the patient throughout the study, or influence the findings of the studies or their interpretations, or impede the patient’s ability to complete the entire duration of study.

Any clinically significant abnormal findings in physical examination, vital signs, safety lab tests during screening/run-in period, which in the opinion of the investigator, may pu