NCT04783389

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

Terminated Phase 2 Results posted Last updated 17 October 2023

What this trial tests

Phase 2 trial testing CBP-201 in Chronic Rhinosinusitis With Nasal Polyps in 40 participants. Terminated before completion.

Timeline

16 June 2021

Primary endpoint
15 April 2022

10 June 2022

Quick facts

Lead sponsor	Connect Biopharm LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	16 June 2021
Primary completion	15 April 2022
Estimated completion	10 June 2022
Sites	68 locations across Ukraine, Poland, China, United States, Spain

Drugs / interventions tested

• CBP-201 — full drug profile →
• Placebo

Conditions studied

• Chronic Rhinosinusitis With Nasal Polyps — all drugs for Chronic Rhinosinusitis With Nasal Polyps →

Sponsor

Connect Biopharm LLC — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Rhinosinusitis With Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Endoscopic Nasal Polyp Score (NPS) Primary · From Baseline to Week 24

Change from baseline at Week 24 in endoscopic Nasal Polyp Score (NPS). Endoscopic NPS is assessed by central clinical specialist assessment of video recordings of nasal endoscopy. NPS is graded based on polyp size (recorded as the sum of the right and left nostril scores with a range of 0 to 8; higher scores indicate worse status). The scoring for each nostril is as follows: 0 No polyps, 1 Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 Polyps reaching below the lower border of the middle turbinate, 3 Large polyps reaching the lower border of

Group	Value	95% CI
CBP-201 300 mg SC Q2W	0	± NA

Change in Average Daily Nasal Congestion Score (NCS) Primary · From Baseline to Week 24

Change from baseline at Week 24 in average daily Nasal Congestion Score (NCS). Daily NCS wase assessed by patient diary from screening and throughout the study by using a 0 to 3 categorical scale for severity of symptoms from none to severe over the past 24 hours. The patient diary prompt: "How would you rate nasal congestion over the last 24 hours?" The answers are: 0 None,1 Minor, 2 Moderate, 3 Severe. The lowest possible weekly average is 0 and the highest possible is 3. The higher the NCS score, the worse the symptoms. Change from baseline in weekly average score is the outcome. Maximal im

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-0.8571	± 1.4142
CBP-201 300 mg SC Q4W	-1.8000

Change in University of Pennsylvania Smell Identification Test (UPSIT) Secondary · From Baseline to Week 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.

Group	Value	95% CI
CBP-201 300 mg Q2W	6
CBP-201 300 mg Q4W	13

Change in Visual Analogue Scale for Rhinosinusitis (VAS-RS) Secondary · From Baseline to Week 24

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

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-33.00
CBP-201 300 mg SC Q4W	-29.70

Change in Total Nasal Symptom Score (TNSS) Secondary · From Baseline to Week 24

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.

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-2
CBP-201 300 mg SC Q4W	-2

Change in 22-item Sinonasal Outcome Test (SNOT-22) Secondary · From Baseline to Week 24

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 worsen

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-17
CBP-201 300 mg SC Q4W	-6

Change in Average Daily Anterior Rhinorrhea Score Secondary · From Baseline to Week 24

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

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-0.61	± 1.273
CBP-201 300 mg SC Q4W	-1.25

Change in Average Daily Posterior Rhinorrhea Score Secondary · From Baseline to Week 24

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

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-0.66	± 0.485
CBP-201 300 mg SC Q4W	0.25

Change in Average Daily Loss of Smell Score Secondary · From Baseline to Week 24

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.

Group	Value	95% CI
CBP-201 300 mg SC Q2W	0.750	± 0.5893
CBP-201 300 mg SC Q4W	0.8571

Change in Daily Subject-assessed Nasal Peak Inspiratory Flow (NPIF) Secondary · From Baseline to Week 24

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.

Group	Value	95% CI
CBP-201 300 mg SC Q2W	46.5714	± 66.8721
CBP-201 300 mg SC Q4W	152.5000

Change From Baseline in Blood Level of IgE Secondary · From Baseline to Week 32

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.

Group	Value	95% CI
CBP-201 300 mg SC Q2W	-35794.02

Change From Baseline in Peripheral Eosinophil Counts Secondary · From Baseline to Week 32

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.

Group	Value	95% CI
CBP-201 300 mg Q2W	0.30

Adverse events — posted to ClinicalTrials.gov

Time frame: Both AEs and SAEs were recorded from the time the patient signs the ICF until Visit 17 (32 weeks) or Early Termination Visit, whichever occured first.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBP-201 300 mg Q2W

Serious: 0/13 (0%)

Deaths: 0/13

CBP-201 Dose 2

Serious: 0/13 (0%)

Deaths: 0/13

Placebo

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (8 terms — click to expand)

Reaction	System	CBP-201 300 mg Q2W	CBP-201 Dose 2	Placebo
Injection site erythema	General disorders	—	—	—
Injection site oedema	General disorders	—	—	—
Injection site pruritis	General disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Migraine	Nervous system disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—

Data from ClinicalTrials.gov NCT04783389 adverse events section.

Sponsor's own description

This study will evaluate the effect of CBP-201, rademikibart, in adult patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biologics for chronic rhinosinusitis.
   Chong LY, Piromchai P, Sharp S, Snidvongs K, et al · · 2021 · cited 44× · PMID 33710614 · DOI 10.1002/14651858.cd013513.pub3