A Study to Evaluate CBP-201, Rademikibart, in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps

CT change from baseline at Week 24 in Lund-Mackay Computed Tomography scores. To calculate the Lund-Mackay score on a CT scan of the paranasal sinuses and ostiomeatal complex, the central blinded reader assigns each sinus a score from 0-2: 0 (no abnormality), 1 (partial opacification) or 2 (complete opacification). The ostiomeatal complex is assigned a score of either 0 (not obstructed) or 2 (obstructed).The sinuses are grouped into: frontal sinus, anterior ethmoidal cells, posterior ethmoidal cells, maxillary sinus, sphenoid sinus, ostiomeatal complex. Each side is graded separately. A combined score from 0 to 24 is possible with 0 being no abnormality and 24 being complete obstruction. The maximal possible change from baseline score would be -24 and the maximal worsening from baseline score would be +24.

Change from baseline at Week 24 in University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a commercially available, validated, "scratch and sniff" smell test that has 40 items, where each item has 1 correct answer and 3 incorrect answers or "distractors". An UPSIT result is scored out of 40 where a higher score indicates better olfaction (maximum being 40) and 0 indicates the worst possible olfaction outcome. The maximal possible improvement from baseline would be +40 and the worst possible change from baseline would be a score of -40.

Change from baseline at Week 24 in Visual Analogue Scale for Rhinosinusitis (VAS-RS).

The Visual Analogue Scale for Rhinosinusitis (VAS-RS) is a 10 cm linear scale that ranges from "none" to "more than I can imagine" for each of 14 defined nasal symptoms (runny nose, loss of smell, etc). The VAS instructions direct the patient to mark a vertical line at the point that best corresponds to how bothersome their symptoms have been between visits the VAS-RS is collected. Site staff measure the distance from none to the patient's mark for each of the 14 symptoms and adds the total number of cm. The least possible score is 0 reflecting no symptoms and the maximal score is 140 reflecting the worst possible symptoms. The best possible outcome change from baseline to week 24 would be a score of -140 and the worst possible change from baseline score would be +140.

Change from baseline at Week 24 in Total Nasal Symptom Score (TNSS). The Total Nasal Symptom Score is a Patient Reported Outcome which is a total of 3 sub-question scores which are scored 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe) for Nasal Obstruction, Itching/Sneezing, and Secretion/Runny Nose. The total possible TNSS score is 9 representing the worst symptoms and the a score of 0 represents no symptoms. The worst change from baseline to Week 24 would be a score of +9 and the best possible change from baseline score would be -9.

Change from baseline at Week 24 in 22-item Sinonasal Outcome Test (SNOT-22) The Sino-Nasal Outcome Test (SNOT-22) is a 22-item list of symptoms and social/emotional consequences related to the patient's rhinosinusitis, using a 5-point scale (0,1,2,3,4,5), where score of 0 indicates No Problem, 2 for Very Mild Problem, 3 for Mild or Slight Problem, 4 for Moderate Problem, and 5 for Problem as bad as it can be. The SNOT-22 score range is 0-110, with higher scores representing worse symptoms associated with disease. A maximum improvement or outcome from baseline would be -110 and a maximum worsening of symptoms from baseline would be +110.

Change from baseline at Week 24 in average daily anterior rhinorrhea score. Participants reported symptoms daily on an electronic diary. The diary prompt was "How would you rate your anterior rhinorrhea (the discharge draining from your nose, "runny nose") in the past 24 hours?" The participant entered a score from 0-4: 0 No noticeable discharge from my nose; 1 Minor discharge from my nose, did not require tissues; 2 Some discharge from my nose, required a few tissues; 3 Significant discharge from my nose; 4 Near constant discharge from my nose. The higher the score the worse the outcome with a range of 0-4. The maximum improvement in weekly average of daily symptoms was -4 and the maximal worsening in symptoms was +4.

Change from baseline at Week 24 in average daily posterior rhinorrhea score. Participants reported symptoms daily on an electronic diary. The diary prompt was "How would you rate your posterior rhinorrhea (postnasal phlegm dripping into your throat) in the past 24 hours?" The participant entered a score from 0-4: 0 No noticeable postnasal drip; 1 Some minor postnasal drip; 2 Moderate postnasal drip; 3 Significant postnasal drip; 4 Near constant postnasal drip.

The higher the score the worse the outcome with a range of 0-4. The maximum improvement in weekly average of daily symptoms was -4 and the maximal worsening in symptoms was +4.

Change from baseline at Week 24 in average daily loss of smell score Participants reported symptoms daily on an electronic diary. The diary prompt was "How would you rate your ability to smell?" The participant entered a score from 0-3: 0 Not able to smell anything; 1 Can smell only strong odors; 2 Can smell some, but not all, odors; 3 Have no problem smelling The maximum improvement in weekly average of daily symptoms was +3 and the maximal worsening in symptoms was -3.

Change from baseline at Week 24 in daily subject-assessed nasal peak inspiratory flow (NPIF).

Participants performed a nasal peak inspiratory flow (NPIF) maneuver twice daily at home and recorded the result on an electronic diary device. An improvement in flow rate (L/min) is considered an improvement and a decrease in flow rate is considered a worsening of symptoms. A change from baseline improvement in flow rate would be a positive number and a worsening from baseline would be a negative number. MCID is considered to be a change from baseline of approximately 20 L/min.

Change from baseline will be summarized with descriptive statistics in blood level of IgE.

IgE (ng/mL) was measured in blood samples sent to a central clinical laboratory.

A negative change from baseline will be considered a clinical improvement and a positive change from baseline will be considered a lack of improvement.

Change from baseline will be summarized with descriptive statistics in peripheral eosinophil counts.

Eosinophil counts in the blood (reported as 10^9/L) were determined from blood samples sent to a central clinical laboratory.

A negative change from baseline will be considered a clinical improvement and a positive change from baseline will be considered a lack of clinical improvement.

Change from baseline will be summarized with descriptive statistics in eosinophil cationic protein (ECP).

Eosinophil cationic protein (reported as ng/mL) was measured in blood samples collected from participants and sent to a central clinical laboratory for processing. An decrease in ECP will be considered an improvement in outcome and an increase will be considered a lack of improvement in clinical outcome.

Change from baseline will be summarized with descriptive statistics in thymus and activation-regulated chemokine (TARC).

TARC (reported in pg/mL) was measured in blood samples collected from participants and sent to a central clinical laboratory for processing. A decrease in TARC will be considered an improvement in clinical outcome and an increase in TARC will be considered a lack of clinical improvement.

Change from baseline will be summarized with descriptive statistics in Eotaxin-3.

Eotaxin-3 (reported in pg/mL) was measured in blood samples collected from participants and sent to a central clinical laboratory for processing. A decrease from baseline will be considered a clinically improvement and an increase will be considered a lack of improvement.

Change from baseline will be summarized with descriptive statistics in periostin.

Periostin (reported in ng/mL) was measured in blood samples collected from participants and sent to a central clinical laboratory for processing. A decrease from baseline will be considered a positive clinical outcome and an increase will be be considered to lack a positive outcome.