Trial Outcomes & Findings for A Study to Evaluate CBP-201, Rademikibart, in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (NCT NCT04783389)
NCT ID: NCT04783389
Last Updated: 2023-10-17
Results Overview
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 the inferior turbinate or large polyps medial to the middle turbinate (i.e., reaching below the middle turbinate), 4 Large polyps causing complete obstruction of the inferior nasal cavity (i.e., touching the floor of the nose). The most improvement improvement possible from baseline would be -8 and the max worsening possible is +8.
TERMINATED
PHASE2
40 participants
From Baseline to Week 24
2023-10-17
Participant Flow
Participant milestones
| Measure |
CBP-201 300 mg SC Q2W
CBP-201 300 mg Q2W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
CBP-201 300 mg SC Q4W
CBP-201 300 mg Q4W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
14
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
14
|
Reasons for withdrawal
| Measure |
CBP-201 300 mg SC Q2W
CBP-201 300 mg Q2W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
CBP-201 300 mg SC Q4W
CBP-201 300 mg Q4W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Termination of Study by Sponsor
|
10
|
12
|
14
|
Baseline Characteristics
Three NPS endoscopy videos were deemed not evaluable by the central reader.
Baseline characteristics by cohort
| Measure |
CBP-201 300 mg SC Q2W
n=13 Participants
CBP-201 300 mg Q2W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
CBP-201 Dose 2
n=13 Participants
CBP-201 300 mg Q4W subcutaneous (SC) injection.
CBP-201: CBP-201 subcutaneous (SC) injection.
|
Placebo
n=14 Participants
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
10 Participants
n=14 Participants
|
32 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
4 Participants
n=14 Participants
|
8 Participants
n=40 Participants
|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 14.80 • n=13 Participants
|
47.3 years
STANDARD_DEVIATION 11.35 • n=13 Participants
|
47.9 years
STANDARD_DEVIATION 17.96 • n=14 Participants
|
49.4 years
STANDARD_DEVIATION 14.65 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=14 Participants
|
12 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=13 Participants
|
8 Participants
n=13 Participants
|
9 Participants
n=14 Participants
|
28 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
13 Participants
n=14 Participants
|
37 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
4 Participants
n=14 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
10 Participants
n=14 Participants
|
23 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=13 Participants
|
7 participants
n=13 Participants
|
8 participants
n=14 Participants
|
20 participants
n=40 Participants
|
|
Region of Enrollment
China
|
7 participants
n=13 Participants
|
4 participants
n=13 Participants
|
4 participants
n=14 Participants
|
15 participants
n=40 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=13 Participants
|
2 participants
n=13 Participants
|
2 participants
n=14 Participants
|
5 participants
n=40 Participants
|
|
Nasal Polyp Score
|
5.5 units on a scale
STANDARD_DEVIATION 1.73 • n=12 Participants • Three NPS endoscopy videos were deemed not evaluable by the central reader.
|
5.5 units on a scale
STANDARD_DEVIATION 1.38 • n=12 Participants • Three NPS endoscopy videos were deemed not evaluable by the central reader.
|
5.6 units on a scale
STANDARD_DEVIATION 1.56 • n=13 Participants • Three NPS endoscopy videos were deemed not evaluable by the central reader.
|
5.5 units on a scale
STANDARD_DEVIATION 1.52 • n=37 Participants • Three NPS endoscopy videos were deemed not evaluable by the central reader.
|
|
Nasal Congestion Score (NCS)
|
2.4945 units on a scale
STANDARD_DEVIATION 0.5365 • n=13 Participants
|
2.1429 units on a scale
STANDARD_DEVIATION 0.5919 • n=13 Participants
|
2.4507 units on a scale
STANDARD_DEVIATION 0.5090 • n=14 Participants
|
2.3649 units on a scale
STANDARD_DEVIATION 0.5544 • n=40 Participants
|
|
Nasal Peak Inspiratory Flow (NPIF) - AM
|
74.5 L/min
STANDARD_DEVIATION 47.36 • n=13 Participants
|
64.5 L/min
STANDARD_DEVIATION 32.38 • n=13 Participants
|
75.7 L/min
STANDARD_DEVIATION 65.48 • n=14 Participants
|
71.7 L/min
STANDARD_DEVIATION 49.68 • n=40 Participants
|
|
Nasal Peak Inspiratory Flow (NPIF) - PM
|
69.1 L/min
STANDARD_DEVIATION 44.36 • n=13 Participants
|
70.4 L/min
STANDARD_DEVIATION 35.73 • n=13 Participants
|
75.0 L/min
STANDARD_DEVIATION 70.68 • n=14 Participants
|
71.6 L/min
STANDARD_DEVIATION 51.68 • n=40 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: The original intent of the study was to analyze the Full Analysis Set at week 24 but due to the early termination of the study, most patients were discontinued before reaching the 24 week treatment timepoint. Data for Week 24 were not complete for any participant in the CBP-201 300 mg Q4W and Placebo Arms.
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 the inferior turbinate or large polyps medial to the middle turbinate (i.e., reaching below the middle turbinate), 4 Large polyps causing complete obstruction of the inferior nasal cavity (i.e., touching the floor of the nose). The most improvement improvement possible from baseline would be -8 and the max worsening possible is +8.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Endoscopic Nasal Polyp Score (NPS)
|
0 score on a scale
Standard Deviation NA
Only one patient's data available at Week 24 for this treatment group.
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze the results from the Full Analysis Set at 24 weeks but due to the early termination of the study, most patients were discontinued prior to reaching the 24 week endpoint. Data for Week 24 were not collected for any participant in the Placebo Arm.
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 improvement in NCS would be -3 and maximal worsening would be +3.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=2 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Average Daily Nasal Congestion Score (NCS)
|
-0.8571 score on a scale
Standard Deviation 1.4142
|
-1.8000 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze the Full Analysis Set at Week 24 but due to early termination of the study and too few CTs available for analysis, this endpoint was not collected for any of the treatment groups.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. There were no subjects in the Placebo treatment groups who recorded an UPSIT assessment at 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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in University of Pennsylvania Smell Identification Test (UPSIT)
|
6 score on a scale
|
13 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data was not collected for any of the Placebo treatment group at 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 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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Visual Analogue Scale for Rhinosinusitis (VAS-RS)
|
-33.00 units on a scale
|
-29.70 units on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data was not collected for the placebo treatment group at Week 24 weeks.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Total Nasal Symptom Score (TNSS)
|
-2 score on a scale
|
-2 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data were not collected at Week 24 for any participant in the placebo treatment group.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in 22-item Sinonasal Outcome Test (SNOT-22)
|
-17 score on a scale
|
-6 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data were not collected at Week 24 for any participant in the placebo treatment group.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=2 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Average Daily Anterior Rhinorrhea Score
|
-0.61 score on a scale
Standard Deviation 1.273
|
-1.25 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data were not collected at Week 24 for any participant in the placebo treatment group.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=2 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Average Daily Posterior Rhinorrhea Score
|
-0.66 score on a scale
Standard Deviation 0.485
|
0.25 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data were not collected at Week 24 for any participants in the placebo treatment group.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=2 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Average Daily Loss of Smell Score
|
0.750 score on a scale
Standard Deviation 0.5893
|
0.8571 score on a scale
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: The intent was to analyze change from baseline at 24 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. Data were not collected at Week 24 for any participant.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=2 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change in Daily Subject-assessed Nasal Peak Inspiratory Flow (NPIF)
|
46.5714 L/min
Standard Deviation 66.8721
|
152.5000 L/min
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but due to early termination of the study and too little data, this endpoint was not analyzed. No data was reported at 32 weeks from participants in the CBP-201 300 SC Q4W or placebo treatment groups.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change From Baseline in Blood Level of IgE
|
-35794.02 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but no data was collected at 32 weeks for participants in the CBP-201 SC Q4W or placebo treatment groups.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change From Baseline in Peripheral Eosinophil Counts
|
0.30 10^9 cells/L
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but no data was collected at week 32 from participants in the CBP-201 300 mg SC Q4W or placebo treatment groups.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change From Baseline in Eosinophil Cationic Protein (ECP)
|
-20.68 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but no data was collected at Week 32 from the CBP-201 300 mg SC Q4W or placebo treatment groups.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but due to early termination of the study no data was collected at Week 32 for participants in the CBP-201 300 mg SC Q4W or placebo treatment groups.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change From Baseline in Eotaxin-3
|
0.040 pg/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 32Population: The intent was to analyze change from baseline at 32 weeks in the Full Analysis Set but due to early termination no data was collected for week 32 from participants in the CBP-201 300 Q4W or placebo treatment groups.
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.
Outcome measures
| Measure |
CBP-201 300 mg SC Q2W
n=1 Participants
CBP-201 300 mg subcutaneous (SC) injection Q2W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q2W.
|
CBP-201 300 mg Q4W
CBP-201 300 mg subcutaneous (SC) injection Q4W.
CBP-201: CBP-201 300 mg subcutaneous (SC) injection Q4W.
|
Placebo
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
Change From Baseline in Periostin
|
106.52 ng/mL
|
—
|
—
|
Adverse Events
CBP-201 300 mg Q2W
CBP-201 Dose 2
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBP-201 300 mg Q2W
n=13 participants at risk
CBP-201 300 mg Q2W subcutaneous (SC) injection.
CBP-201: CBP-201 300 mg Q2W subcutaneous (SC) injection.
|
CBP-201 Dose 2
n=13 participants at risk
CBP-201 300 mg Q4W subcutaneous (SC) injection.
CBP-201: CBP-201 300 mg Q4W subcutaneous (SC) injection.
|
Placebo
n=14 participants at risk
Placebo subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/14 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
General disorders
Injection site oedema
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/14 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
General disorders
Injection site pruritis
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/14 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.1%
1/14 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/14 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.1%
1/14 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.1%
1/14 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
7.7%
1/13 • Number of events 1 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
0.00%
0/14 • 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.
The AE definition for this study was in line with the CT.gov definition. In addition, AEs of Special Interest (AESI) were also followed closely per FDA recommendation. AESIs for this study: * Conjunctivitis * Keratitis * Anaphylaxis * AE of injection site reaction lasting \>24 hours * AST/ALT elevated \>5X ULN * Parasitic and opportunistic infections * Pregnancy * Symptomatic overdose (i.e. overdose of study drug resulting in an adverse event)
|
Additional Information
Dr. Malinda Longphre, PhD, Head of Clinical Operations
Connect Biopharma
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60