Trial Outcomes & Findings for A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) (NCT NCT04700449)
NCT ID: NCT04700449
Last Updated: 2024-05-06
Results Overview
Change in adapted Mayo score from baseline at week 12 compared between CBP-307 0.2 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
The adapted Mayo score was evaluated at screening and Week 12 (or early termination visit) during the study Stage 1 as well as at Week 24 (only for the sub-study 2) and Week 48 (or early termination visit) during the study Stage 2.
Results posted on
2024-05-06
Participant Flow
Because 1 subject in stage 1 placebo group was randomized but not treated, so the Enrollment number in the Protocol Section (145) conflicts with the number of participants Started in the Participant Flow module (144).
Participant milestones
| Measure |
Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
Placebo capsules oral administration.
Placebo: Placebo capsules oral administration
|
Open-Label 0.2 mg CBP-307
0.2 mg CBP-307 capsule oral administration
|
|---|---|---|---|---|
|
Stage 1: Double-Blind Period
STARTED
|
39
|
53
|
52
|
0
|
|
Stage 1: Double-Blind Period
COMPLETED
|
28
|
50
|
47
|
0
|
|
Stage 1: Double-Blind Period
NOT COMPLETED
|
11
|
3
|
5
|
0
|
|
Stage 2 Sub-study 1
STARTED
|
12
|
21
|
13
|
0
|
|
Stage 2 Sub-study 1
COMPLETED
|
10
|
17
|
9
|
0
|
|
Stage 2 Sub-study 1
NOT COMPLETED
|
2
|
4
|
4
|
0
|
|
Stage 2 Sub-study 2
STARTED
|
0
|
0
|
0
|
40
|
|
Stage 2 Sub-study 2
COMPLETED
|
0
|
0
|
0
|
17
|
|
Stage 2 Sub-study 2
NOT COMPLETED
|
0
|
0
|
0
|
23
|
Reasons for withdrawal
| Measure |
Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
Placebo capsules oral administration.
Placebo: Placebo capsules oral administration
|
Open-Label 0.2 mg CBP-307
0.2 mg CBP-307 capsule oral administration
|
|---|---|---|---|---|
|
Stage 1: Double-Blind Period
Adverse Event
|
5
|
0
|
1
|
0
|
|
Stage 1: Double-Blind Period
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Stage 1: Double-Blind Period
Withdrawal by Subject
|
2
|
2
|
2
|
0
|
|
Stage 1: Double-Blind Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Stage 1: Double-Blind Period
COVID-19 Restriction
|
3
|
0
|
1
|
0
|
|
Stage 1: Double-Blind Period
Other
|
0
|
0
|
1
|
0
|
|
Stage 2 Sub-study 1
Adverse Event
|
0
|
1
|
0
|
0
|
|
Stage 2 Sub-study 1
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Stage 2 Sub-study 1
Lack of Efficacy
|
0
|
0
|
2
|
0
|
|
Stage 2 Sub-study 1
COVID-19 Restriction
|
0
|
0
|
1
|
0
|
|
Stage 2 Sub-study 1
Other
|
1
|
2
|
0
|
0
|
|
Stage 2 Sub-study 2
Adverse Event
|
0
|
0
|
0
|
7
|
|
Stage 2 Sub-study 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Stage 2 Sub-study 2
Lack of Efficacy
|
0
|
0
|
0
|
9
|
|
Stage 2 Sub-study 2
COVID-19 Restriction
|
0
|
0
|
0
|
1
|
|
Stage 2 Sub-study 2
Other
|
0
|
0
|
0
|
5
|
Baseline Characteristics
Demographic and Other Baseline Characteristics (Stage 1) - Randomized Set
Baseline characteristics by cohort
| Measure |
Double-Blind 0.1 mg CBP-307
n=39 Participants
0.1 mg CBP-307 capsules oral administration.
|
Double-Blind 0.2 mg CBP-307
n=53 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
Placebo: Placebo capsules oral administration
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 13.41 • n=5 Participants • Demographic and Other Baseline Characteristics (Stage 1) - Randomized Set
|
42.1 years
STANDARD_DEVIATION 10.66 • n=7 Participants • Demographic and Other Baseline Characteristics (Stage 1) - Randomized Set
|
41.2 years
STANDARD_DEVIATION 9.86 • n=5 Participants • Demographic and Other Baseline Characteristics (Stage 1) - Randomized Set
|
42 years
STANDARD_DEVIATION 11.14 • n=4 Participants • Demographic and Other Baseline Characteristics (Stage 1) - Randomized Set
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 participants
n=5 Participants
|
48 participants
n=7 Participants
|
46 participants
n=5 Participants
|
133 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
39 participants
n=5 Participants
|
52 participants
n=7 Participants
|
50 participants
n=5 Participants
|
141 participants
n=4 Participants
|
|
Adapt Mayo Score at Baseline
|
6.00 units on a scale
STANDARD_DEVIATION 1.485 • n=5 Participants
|
5.84 units on a scale
STANDARD_DEVIATION 1.361 • n=7 Participants
|
5.93 units on a scale
STANDARD_DEVIATION 1.178 • n=5 Participants
|
5.92 units on a scale
STANDARD_DEVIATION 1.325 • n=4 Participants
|
|
Complete Mayo Score at Baseline
|
8.15 units on a scale
STANDARD_DEVIATION 1.641 • n=5 Participants
|
8.03 units on a scale
STANDARD_DEVIATION 1.518 • n=7 Participants
|
8.12 units on a scale
STANDARD_DEVIATION 1.282 • n=5 Participants
|
8.10 units on a scale
STANDARD_DEVIATION 1.463 • n=4 Participants
|
PRIMARY outcome
Timeframe: The adapted Mayo score was evaluated at screening and Week 12 (or early termination visit) during the study Stage 1 as well as at Week 24 (only for the sub-study 2) and Week 48 (or early termination visit) during the study Stage 2.Change in adapted Mayo score from baseline at week 12 compared between CBP-307 0.2 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=53 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo
|
-2.60 score on a scale
Interval -3.716 to -1.477
|
-1.95 score on a scale
Interval -3.073 to -0.834
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Change in complete Mayo score from baseline at week 12 after treatment. Complete Mayo scores were calculated based on data in stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. The Mayo scores range from 0 to 12 and consist of 4 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Change in Complete Mayo Score From Baseline
|
-3.87 score on a scale
Interval -5.407 to -2.324
|
-3.67 score on a scale
Interval -4.959 to -2.385
|
-2.74 score on a scale
Interval -4.03 to -1.458
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Comparison of clinical response rate at week 12 by adapted Mayo score (defined as a decrease of ≥ 2 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Comparison of Clinical Response Rate by Adapted Mayo Score
|
35.9 percentage of participants
Interval 20.84 to 50.95
|
52.8 percentage of participants
Interval 39.39 to 66.27
|
32.7 percentage of participants
Interval 19.94 to 45.44
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Comparison of clinical response rate at week 12 by complete Mayo score (defined as a decrease of ≥ 3 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Comparison of Clinical Response Rate by Complete Mayo Score
|
35.9 percentage of participants
Interval 20.84 to 50.95
|
50.9 percentage of participants
Interval 37.48 to 64.4
|
28.8 percentage of participants
Interval 16.53 to 41.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Comparison of clinical remission rate at week 12 by adapted Mayo score (defined as a rectal bleeding subscore = 0 and a stool frequency subscore ≤ 1, with an Endoscopy subscore ≤ 1 \[excluding friability\]).
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Comparison of Clinical Remission Rate by Adapted Mayo Score
|
12.8 percentage of participants
Interval 2.33 to 23.31
|
28.3 percentage of participants
Interval 16.17 to 40.43
|
9.6 percentage of participants
Interval 1.6 to 17.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Comparison of clinical remission rate at week 12 by complete Mayo score (defined as a total Mayo score of ≤ 2 points with no individual subscore \> 1 point).
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Comparison of Clinical Remission Rate by Complete Mayo Score
|
10.3 percentage of participants
Interval 0.73 to 19.78
|
20.8 percentage of participants
Interval 9.84 to 31.67
|
5.8 percentage of participants
Interval 0.0 to 12.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Week 12Mucosal healing rate at week 12 after treatment (mucosal healing is defined as Mayo endoscopic subscore ≤ 1)
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Mucosal Healing Rate
|
20.5 percentage of participants
Interval 7.84 to 33.19
|
30.2 percentage of participants
Interval 17.83 to 42.55
|
21.2 percentage of participants
Interval 10.05 to 32.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: for 12 consecutive weeksThe safety and tolerability will be assessed on basis of incidence, type and severity of TEAEs as well as their relations with the investigational product .
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
n=12 Participants
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
n=21 Participants
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
n=13 Participants
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
n=40 Participants
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Gastrointestinal disorders
|
12 cases
|
16 cases
|
14 cases
|
4 cases
|
11 cases
|
3 cases
|
17 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Infections and infestations
|
14 cases
|
13 cases
|
15 cases
|
2 cases
|
6 cases
|
6 cases
|
10 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Investigations
|
13 cases
|
18 cases
|
9 cases
|
5 cases
|
9 cases
|
3 cases
|
13 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Cardiac disorders
|
9 cases
|
13 cases
|
6 cases
|
4 cases
|
4 cases
|
2 cases
|
6 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Eye disorders
|
5 cases
|
11 cases
|
10 cases
|
5 cases
|
7 cases
|
5 cases
|
5 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Nervous system disorders
|
6 cases
|
8 cases
|
9 cases
|
1 cases
|
5 cases
|
1 cases
|
2 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Skin and subcutaneous tissue disorders
|
9 cases
|
5 cases
|
4 cases
|
5 cases
|
2 cases
|
1 cases
|
3 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Blood and lymphatic system disorders
|
6 cases
|
4 cases
|
8 cases
|
1 cases
|
3 cases
|
0 cases
|
5 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Respiratory, thoracic and mediastinal disorders
|
6 cases
|
6 cases
|
5 cases
|
3 cases
|
5 cases
|
1 cases
|
4 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
General disorders and administration site conditions
|
5 cases
|
7 cases
|
4 cases
|
1 cases
|
4 cases
|
0 cases
|
5 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Metabolism and nutrition disorders
|
4 cases
|
7 cases
|
3 cases
|
2 cases
|
4 cases
|
1 cases
|
3 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Hepatobiliary disorders
|
7 cases
|
5 cases
|
1 cases
|
3 cases
|
3 cases
|
1 cases
|
4 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Musculoskeletal and connective tissue disorders
|
2 cases
|
5 cases
|
2 cases
|
2 cases
|
5 cases
|
2 cases
|
3 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Vascular disorders
|
0 cases
|
3 cases
|
3 cases
|
1 cases
|
2 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Renal and urinary disorders
|
3 cases
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
1 cases
|
2 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Injury, poisoning and procedural complications
|
2 cases
|
1 cases
|
0 cases
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Psychiatric disorders
|
1 cases
|
2 cases
|
0 cases
|
0 cases
|
2 cases
|
0 cases
|
2 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Reproductive system and breast disorders
|
0 cases
|
1 cases
|
1 cases
|
0 cases
|
1 cases
|
1 cases
|
0 cases
|
|
Incidence, Type and Severity of Treatment Emergent Adverse Event (TEAE)
Ear and labyrinth disorders
|
1 cases
|
1 cases
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
1 cases
|
SECONDARY outcome
Timeframe: for 12 consecutive weeksThe safety and tolerability will be assessed on basis of incidence, type and severity of SAEs as well as their relations with the investigational product and SAEs that lead to discontinuation of study.
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
n=12 Participants
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
n=21 Participants
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
n=13 Participants
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
n=40 Participants
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Colitis ulcerative
|
4 cases
|
2 cases
|
2 cases
|
0 cases
|
0 cases
|
0 cases
|
6 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Gastritis
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Transitional cell carcinoma
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Ovarian cyst
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Appendicitis
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Large intestine polyp
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Anal abscess
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Cholera
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Serious Adverse Event (SAE)
Cytomegalovirus infection
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
SECONDARY outcome
Timeframe: for 12 consecutive weeksPopulation: Treatment-Emergent Adverse Events Leading to Study Drug Withdrawal
The safety and tolerability will be assessed on basis of AEs that lead to discontinuation of study, and AEs of special interest (cardiac events as well as pulmonary function tests, ophthalmologic examinations, skin examinations, and nervous system physical examinations)
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=53 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
n=12 Participants
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
n=21 Participants
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
n=13 Participants
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
n=40 Participants
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Incidence, Type and Severity of Adverse Events (AE)
Eye disorders (Leading to Drug Withdrawal)
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Hepatobiliary disorders (Leading to Drug Withdrawal)
|
4 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Gastrointestinal disorders (Leading to Drug Withdrawal)
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
3 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) (Leading to Drug Withdrawal)
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Infections and infestations (Leading to Drug Withdrawal)
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
2 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Hepatobiliary disorders (Treatment-Emergent Adverse Events of Special Interest)
|
4 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Cardiac disorders (Treatment-Emergent Adverse Events of Special Interest)
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
2 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Eye disorders (Treatment-Emergent Adverse Events of Special Interest)
|
1 cases
|
1 cases
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
1 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Respiratory disorders (Treatment-Emergent Adverse Events of Special Interest)
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Investigations (Treatment-Emergent Adverse Events of Special Interest)
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Incidence, Type and Severity of Adverse Events (AE)
Infections and infestations (Treatment-Emergent Adverse Events of Special Interest)
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
1 cases
|
SECONDARY outcome
Timeframe: at Week 12Change from baseline in adapted Mayo score at Week 12 between CBP-307 0.1 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
Outcome measures
| Measure |
Double-Blind 0.2 mg CBP-307
n=39 Participants
0.2 mg CBP-307 capsules oral administration.
|
Double-Blind Placebo
n=52 Participants
Placebo capsules oral administration.
|
Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Adapted Mayo Score: 0.1 mg Versus Placebo
|
-2.90 score on a scale
Interval -4.121 to -1.679
|
-1.95 score on a scale
Interval -3.073 to -0.834
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 Double-Blind 0.1 mg CBP-307
Serious events: 6 serious events
Other events: 37 other events
Deaths: 0 deaths
Stage 1 Double-Blind 0.2 mg CBP-307
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Stage 1 Double-Blind Placebo
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Stage 2 Double-Blind 0.1 mg CBP-307
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage 2 Double-Blind 0.2 mg CBP-307
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Stage 2 Double-Blind Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Stage 2 Open-label 0.2 mg CBP-307
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Double-Blind 0.1 mg CBP-307
n=39 participants at risk
0.1 mg CBP-307 capsules oral administration.
|
Stage 1 Double-Blind 0.2 mg CBP-307
n=53 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
Stage 1 Double-Blind Placebo
n=52 participants at risk
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
n=12 participants at risk
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
n=21 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
n=13 participants at risk
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
n=40 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
10.3%
4/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
3.8%
2/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
3.8%
2/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.0%
6/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.6%
1/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
4.8%
1/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Infections and infestations
Cholera
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
Other adverse events
| Measure |
Stage 1 Double-Blind 0.1 mg CBP-307
n=39 participants at risk
0.1 mg CBP-307 capsules oral administration.
|
Stage 1 Double-Blind 0.2 mg CBP-307
n=53 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
Stage 1 Double-Blind Placebo
n=52 participants at risk
Placebo capsules oral administration.
|
Stage 2 Double-Blind 0.1 mg CBP-307
n=12 participants at risk
0.1 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind 0.2 mg CBP-307
n=21 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
Stage 2 Double-Blind Placebo
n=13 participants at risk
Placebo capsules oral administration.
|
Stage 2 Open-label 0.2 mg CBP-307
n=40 participants at risk
0.2 mg CBP-307 capsules oral administration.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
30.8%
12/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
30.2%
16/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
26.9%
14/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
33.3%
4/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
52.4%
11/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
23.1%
3/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
42.5%
17/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Infections and infestations
Infections and infestations
|
35.9%
14/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
24.5%
13/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
28.8%
15/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
16.7%
2/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
28.6%
6/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
46.2%
6/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
25.0%
10/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Investigations
Investigations
|
33.3%
13/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
34.0%
18/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
17.3%
9/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
41.7%
5/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
42.9%
9/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
23.1%
3/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
32.5%
13/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Cardiac disorders
Cardiac disorders
|
23.1%
9/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
24.5%
13/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
11.5%
6/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
33.3%
4/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
19.0%
4/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.4%
2/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.0%
6/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Eye disorders
Eye disorders
|
12.8%
5/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
20.8%
11/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
19.2%
10/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
41.7%
5/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
33.3%
7/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
38.5%
5/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
12.5%
5/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Nervous system disorders
Nervous system disorders
|
15.4%
6/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.1%
8/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
17.3%
9/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
23.8%
5/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.0%
2/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
23.1%
9/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.4%
5/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
4/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
41.7%
5/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.5%
2/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.5%
3/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
15.4%
6/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.5%
4/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.4%
8/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
14.3%
3/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
12.5%
5/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
15.4%
6/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
11.3%
6/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.6%
5/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
25.0%
3/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
23.8%
5/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
10.0%
4/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
General disorders
General disorders and administration site conditions
|
12.8%
5/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
13.2%
7/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
4/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
19.0%
4/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
12.5%
5/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
10.3%
4/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
13.2%
7/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.8%
3/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
16.7%
2/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
19.0%
4/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.5%
3/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
17.9%
7/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.4%
5/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
25.0%
3/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
14.3%
3/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
10.0%
4/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
5.1%
2/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.4%
5/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
3.8%
2/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
16.7%
2/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
23.8%
5/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
15.4%
2/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.5%
3/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.7%
3/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.8%
3/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.5%
2/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
7.7%
3/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.0%
2/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
5.1%
2/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
4.8%
1/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Psychiatric disorders
Psychiatric disorders
|
2.6%
1/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
3.8%
2/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
9.5%
2/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
5.0%
2/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
4.8%
1/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
7.7%
1/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
2.6%
1/39 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/53 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
1.9%
1/52 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
8.3%
1/12 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/21 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
0.00%
0/13 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
2.5%
1/40 • Adverse events were persistently monitored throughout the study, from the time of informed consent until 28 days after the last dose, up to 55 weeks.
|
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