Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (NCT NCT05017480)
NCT ID: NCT05017480
Last Updated: 2024-05-01
Results Overview
The percentage of subjects whose IGA score is 0-1 and decreased by ≥2 points The Validated Investigator Global Assessment for AD (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
330 participants
Primary outcome timeframe
Baseline to Week16
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
Group A: CBP-201 300mg Q2W
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
Group C: Double-blinded CBP-201 300mg Q2W
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks (Q2W) until W50.
|
Group D: Double-blinded CBP-201 300mg Q4W
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 4 weeks. In order to maintain the injection every 2 weeks blind, when not receiving CBP-201, the subjects receive an injection of placebo 2 ml once every 4 weeks until W50.
|
Group E: Open-Label CBP-201 300mg Q2W
Subjects who have not achieved EASI-50 in the W16 pre-administration treatment assessment will receive the following treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks until W50.
|
|---|---|---|---|---|---|
|
Stage 1 Study
STARTED
|
219
|
111
|
0
|
0
|
0
|
|
Stage 1 Study
COMPLETED
|
209
|
102
|
0
|
0
|
0
|
|
Stage 1 Study
NOT COMPLETED
|
10
|
9
|
0
|
0
|
0
|
|
Stage 2 Study
STARTED
|
0
|
0
|
113
|
112
|
86
|
|
Stage 2 Study
COMPLETED
|
0
|
0
|
107
|
99
|
73
|
|
Stage 2 Study
NOT COMPLETED
|
0
|
0
|
6
|
13
|
13
|
Reasons for withdrawal
| Measure |
Group A: CBP-201 300mg Q2W
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
Group C: Double-blinded CBP-201 300mg Q2W
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks (Q2W) until W50.
|
Group D: Double-blinded CBP-201 300mg Q4W
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 4 weeks. In order to maintain the injection every 2 weeks blind, when not receiving CBP-201, the subjects receive an injection of placebo 2 ml once every 4 weeks until W50.
|
Group E: Open-Label CBP-201 300mg Q2W
Subjects who have not achieved EASI-50 in the W16 pre-administration treatment assessment will receive the following treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks until W50.
|
|---|---|---|---|---|---|
|
Stage 1 Study
Withdrawal by Subject
|
8
|
6
|
0
|
0
|
0
|
|
Stage 1 Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
|
Stage 1 Study
Poor Compliance
|
1
|
1
|
0
|
0
|
0
|
|
Stage 1 Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Stage 2 Study
Withdrawal by Subject
|
0
|
0
|
6
|
9
|
11
|
|
Stage 2 Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Stage 2 Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2 Study
COVID-19
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2 Study
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Missing Data
Baseline characteristics by cohort
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 16.65 • n=219 Participants
|
39.6 years
STANDARD_DEVIATION 17.54 • n=111 Participants
|
38.9 years
STANDARD_DEVIATION 16.93 • n=330 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=219 Participants
|
40 Participants
n=111 Participants
|
113 Participants
n=330 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=219 Participants
|
71 Participants
n=111 Participants
|
217 Participants
n=330 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Asian
|
219 Participants
n=219 Participants
|
111 Participants
n=111 Participants
|
330 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=219 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=330 Participants
|
|
BMI
|
23.66 kg/m^2
STANDARD_DEVIATION 3.932 • n=219 Participants
|
24.98 kg/m^2
STANDARD_DEVIATION 4.829 • n=111 Participants
|
24.10 kg/m^2
STANDARD_DEVIATION 4.293 • n=330 Participants
|
|
Severity of Atopic Dermatitis at Baseline
Moderate (IGA=3)
|
99 Participants
n=219 Participants
|
50 Participants
n=111 Participants
|
149 Participants
n=330 Participants
|
|
Severity of Atopic Dermatitis at Baseline
Severe (IGA=4)
|
120 Participants
n=219 Participants
|
61 Participants
n=111 Participants
|
181 Participants
n=330 Participants
|
|
EASI at Baseline
|
29.27 units on a scale
STANDARD_DEVIATION 11.658 • n=219 Participants
|
28.62 units on a scale
STANDARD_DEVIATION 12.092 • n=111 Participants
|
29.05 units on a scale
STANDARD_DEVIATION 11.791 • n=330 Participants
|
|
PP-NRS at Baseline
|
7.19 units on a scale
STANDARD_DEVIATION 1.680 • n=219 Participants
|
7.17 units on a scale
STANDARD_DEVIATION 1.459 • n=111 Participants
|
7.18 units on a scale
STANDARD_DEVIATION 1.607 • n=330 Participants
|
|
BSA at Baseline
|
48.55 units on a scale
STANDARD_DEVIATION 20.666 • n=219 Participants
|
46.64 units on a scale
STANDARD_DEVIATION 21.581 • n=111 Participants
|
47.91 units on a scale
STANDARD_DEVIATION 20.965 • n=330 Participants
|
|
SCORAD at Baseline
|
68 units on a scale
STANDARD_DEVIATION 12.940 • n=219 Participants
|
67.37 units on a scale
STANDARD_DEVIATION 12.531 • n=111 Participants
|
67.79 units on a scale
STANDARD_DEVIATION 12.788 • n=330 Participants
|
|
POEM at Baseline
|
21.4 units on a scale
STANDARD_DEVIATION 6.10 • n=219 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 6.13 • n=111 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 6.11 • n=330 Participants
|
|
DLQI at Baseline
|
16.0 units on a scale
STANDARD_DEVIATION 7.32 • n=217 Participants • Missing Data
|
15.7 units on a scale
STANDARD_DEVIATION 6.11 • n=108 Participants • Missing Data
|
15.9 units on a scale
STANDARD_DEVIATION 6.93 • n=325 Participants • Missing Data
|
PRIMARY outcome
Timeframe: Baseline to Week16The percentage of subjects whose IGA score is 0-1 and decreased by ≥2 points The Validated Investigator Global Assessment for AD (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Investigator Global Assessment (IGA) (0-1)
|
29.0 percentage of participants
Interval 23.0 to 35.0
|
5.9 percentage of participants
Interval 1.4 to 10.4
|
SECONDARY outcome
Timeframe: Baseline to Week16The percentage of subjects achieving EASI-75 (EASI score is decreased by ≥75% from baseline) The total EASI score ranges from 0 (lowest) to 72 (highest); the higher the score, the higher the severity of AD (more severe).
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Eczema Area and Severity Index (EASI)-75
|
58.6 percentage of participants
Interval 51.9 to 65.3
|
22.6 percentage of participants
Interval 14.5 to 30.7
|
SECONDARY outcome
Timeframe: Baseline to Week16The percentage of subjects whose weekly average PP-NRS is decreased by ≥ 4 points The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=216 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=110 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 4 Points)
|
36.3 percentage of participants
Interval 29.7 to 42.8
|
10.5 percentage of participants
Interval 4.5 to 16.5
|
SECONDARY outcome
Timeframe: Baseline to Week16The percentage of subjects whose weekly average PP-NRS is decreased by ≥ 3 points The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=218 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 3 Points)
|
50.0 percentage of participants
Interval 43.2 to 56.9
|
20.3 percentage of participants
Interval 12.7 to 28.0
|
SECONDARY outcome
Timeframe: Baseline to Week16Change in the weekly average PP-NRS The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Change in the Weekly Average Peak Pruritus Numerical Rating Scale(PP-NRS)
|
-2.95 score on a scale
Interval -3.28 to -2.62
|
-0.99 score on a scale
Interval -1.46 to -0.53
|
SECONDARY outcome
Timeframe: Baseline to Week16The percentage of subjects achieving EASI-90 (EASI score is decreased by ≥90% from baseline) The total EASI score ranges from 0 (lowest) to 72 (highest); the higher the score, the higher the severity of AD (more severe).
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Eczema Area and Severity Index (EASI)-90
|
33.4 percentage of participants
Interval 27.0 to 39.8
|
6.4 percentage of participants
Interval 1.4 to 11.4
|
SECONDARY outcome
Timeframe: Baseline to Week16Percentage change in the weekly average PP-NRS The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".
Outcome measures
| Measure |
Group A: CBP-201 300mg Q2W
n=219 Participants
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 Participants
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
|---|---|---|
|
Percentage Change in the Weekly Average Peak Pruritus Numerical Rating Scale(PP-NRS)
|
-40.00 percentage change of PP-NRS value
Interval -44.8 to -35.2
|
-13.50 percentage change of PP-NRS value
Interval -20.19 to -6.82
|
Adverse Events
Group A: CBP-201 300mg Q2W
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Group B: Placebo Q2W
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Group C: Double-blinded CBP-201 300mg Q2W
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Group D: Double-blinded CBP-201 300mg Q4W
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Group E: Open-Label CBP-201 300mg Q2W
Serious events: 6 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: CBP-201 300mg Q2W
n=219 participants at risk
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 participants at risk
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
Group C: Double-blinded CBP-201 300mg Q2W
n=113 participants at risk
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks (Q2W) until W50.
|
Group D: Double-blinded CBP-201 300mg Q4W
n=112 participants at risk
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 4 weeks. In order to maintain the injection every 2 weeks blind, when not receiving CBP-201, the subjects receive an injection of placebo 2 ml once every 4 weeks until W50.
|
Group E: Open-Label CBP-201 300mg Q2W
n=85 participants at risk
Subjects who have not achieved EASI-50 in the W16 pre-administration treatment assessment will receive the following treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks until W50.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury,poisoning and procedural complications
|
0.46%
1/219 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.8%
2/111 • Number of events 2 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.2%
1/85 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.46%
1/219 • Number of events 2 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.90%
1/111 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.89%
1/112 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.2%
1/85 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.90%
1/111 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.89%
1/112 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/85 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.88%
1/113 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.2%
1/85 • Number of events 2 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.4%
2/85 • Number of events 3 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Endocrine disorders
Endocrine disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.2%
1/85 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.89%
1/112 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/85 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.88%
1/113 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/85 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Eye disorders
Eye disorders
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/113 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/112 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.2%
1/85 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
Other adverse events
| Measure |
Group A: CBP-201 300mg Q2W
n=219 participants at risk
The subjects receive a subcutaneous injection of CBP-201 600 mg on Day 1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 ml) from Week 2 (W2), and receive treatment at the same dose every 2 weeks thereafter(Q2W) until W14.
|
Group B: Placebo Q2W
n=111 participants at risk
The subjects receive a subcutaneous injection of placebo 4 ml, begin to receive a subcutaneous injection of placebo 2 ml from W2, and receive placebo 2 ml every 2 weeks (Q2W) thereafter until W14.
|
Group C: Double-blinded CBP-201 300mg Q2W
n=113 participants at risk
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks (Q2W) until W50.
|
Group D: Double-blinded CBP-201 300mg Q4W
n=112 participants at risk
Subjects who have achieved EASI-50 in the W16 pre-administration treatment assessment will be 1:1 randomized to one of the following two groups to receive study treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 4 weeks. In order to maintain the injection every 2 weeks blind, when not receiving CBP-201, the subjects receive an injection of placebo 2 ml once every 4 weeks until W50.
|
Group E: Open-Label CBP-201 300mg Q2W
n=85 participants at risk
Subjects who have not achieved EASI-50 in the W16 pre-administration treatment assessment will receive the following treatment starting from W16:
The subjects receive a subcutaneous injection of CBP-201 300 mg every 2 weeks until W50.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
10.5%
23/219 • Number of events 25 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.4%
6/111 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.7%
3/113 • Number of events 3 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
7.1%
8/112 • Number of events 10 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.9%
5/85 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Metabolism and nutrition disorders
hyperuricemia
|
9.6%
21/219 • Number of events 22 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
4.5%
5/111 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
6.2%
7/113 • Number of events 8 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.7%
3/112 • Number of events 3 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
3/85 • Number of events 3 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Skin and subcutaneous tissue disorders
Atopic Dermatitis
|
10.5%
23/219 • Number of events 31 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
17.1%
19/111 • Number of events 23 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
12.4%
14/113 • Number of events 16 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
24.1%
27/112 • Number of events 35 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
16.5%
14/85 • Number of events 20 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
upper respiratory infection
|
6.4%
14/219 • Number of events 14 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
6.3%
7/111 • Number of events 7 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
10.6%
12/113 • Number of events 13 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
10.7%
12/112 • Number of events 13 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
17.6%
15/85 • Number of events 15 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
General disorders
Injection site erythema
|
5.0%
11/219 • Number of events 20 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.90%
1/111 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.7%
3/113 • Number of events 4 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.4%
6/112 • Number of events 7 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
3/85 • Number of events 4 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
COVID-19
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
33.6%
38/113 • Number of events 38 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
30.4%
34/112 • Number of events 35 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
24.7%
21/85 • Number of events 21 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
General disorders
Fever
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
8.0%
9/113 • Number of events 10 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
8.0%
9/112 • Number of events 9 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
8.2%
7/85 • Number of events 8 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
4.4%
5/113 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.4%
6/112 • Number of events 7 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.9%
5/85 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
Tested positive for SARS-CoV-2
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
4/113 • Number of events 4 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
6.2%
7/112 • Number of events 7 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.4%
2/85 • Number of events 2 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Infections and infestations
conjunctivitis
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
4/113 • Number of events 4 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
2.7%
3/112 • Number of events 5 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
7.1%
6/85 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Injury, poisoning and procedural complications
Elevated alanine aminotransferase
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
4/113 • Number of events 4 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
1.8%
2/112 • Number of events 2 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.9%
5/85 • Number of events 5 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
|
Injury, poisoning and procedural complications
Weight Gain
|
0.00%
0/219 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.00%
0/111 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
5.3%
6/113 • Number of events 8 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
0.89%
1/112 • Number of events 1 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
3.5%
3/85 • Number of events 6 • Stage 1 treatment period (Day1~Week16) - Stage 2 treatment period (Week16~Week52) - Follow-up period (Week53~Week60)
|
Additional Information
John Guo, Director of Clinical Operation
Suzhou Connect Biopharmaceuticals, Ltd
Phone: 051253577866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60