Trial Outcomes & Findings for Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis (NCT NCT01585155)
NCT ID: NCT01585155
Last Updated: 2026-01-07
Results Overview
Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day. CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
COMPLETED
PHASE3
21 participants
Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
2026-01-07
Participant Flow
Participant milestones
| Measure |
TA-650
Patients received TA-650 5 mg/kg at Weeks 0, 2, and 6; patients with a decreased CAI score at Week 8 were considered to be responders and received further doses at Week 14 and 22. Non-responders (patients with unchanged/increased CAI score) at Week 8 did not receive further study treatment. Assessments were conducted until Week 30 in responders and until Week 14 in non-responders.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
TA-650
Patients received TA-650 5 mg/kg at Weeks 0, 2, and 6; patients with a decreased CAI score at Week 8 were considered to be responders and received further doses at Week 14 and 22. Non-responders (patients with unchanged/increased CAI score) at Week 8 did not receive further study treatment. Assessments were conducted until Week 30 in responders and until Week 14 in non-responders.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Worsening ulcerative colitis
|
2
|
Baseline Characteristics
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
TA-650
n=21 Participants
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 2.1 • n=9 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30Population: Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.
Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day. CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
Outcome measures
| Measure |
TA-650
n=21 Participants
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Percent of Patients Who Achieved CAI Remission
Weeks 2
|
60.0 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 6
|
80.0 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 8
|
80.0 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 10
|
77.8 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 14
|
87.5 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 18
|
87.5 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 22
|
64.3 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 26
|
85.7 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
Weeks 30
|
64.3 percentage of participants
|
|
Percent of Patients Who Achieved CAI Remission
The last time point
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30Population: Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.
CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
Outcome measures
| Measure |
TA-650
n=21 Participants
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
CAI Score
Baseline
|
9.7 units on a scale
Standard Deviation 2.7
|
|
CAI Score
Weeks 2
|
4.0 units on a scale
Standard Deviation 3.2
|
|
CAI Score
Weeks 6
|
3.5 units on a scale
Standard Deviation 3.5
|
|
CAI Score
Weeks 8
|
3.2 units on a scale
Standard Deviation 3.5
|
|
CAI Score
Weeks 10
|
2.7 units on a scale
Standard Deviation 2.9
|
|
CAI Score
Weeks 14
|
2.7 units on a scale
Standard Deviation 3.0
|
|
CAI Score
Weeks 18
|
2.6 units on a scale
Standard Deviation 2.6
|
|
CAI Score
Weeks 22
|
3.3 units on a scale
Standard Deviation 3.1
|
|
CAI Score
Weeks 26
|
2.5 units on a scale
Standard Deviation 2.3
|
|
CAI Score
Weeks 30
|
3.5 units on a scale
Standard Deviation 2.2
|
|
CAI Score
The last time point
|
5.6 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30Population: Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.
Mayo score consists of four subscores (stool frequency, rectal bleeding, physician's global assessment and findings of endoscopy), each of which was assessed according to a four-level rating scale (0 to 3 points), and was determined from a total of the four subscores (0 to 12 points). In addition, the sum of the subscores (0 to 9 points) for stool frequency, rectal bleeding and physician's global assessment was used as a partial Mayo score. A higher score indicates greater disease activity.
Outcome measures
| Measure |
TA-650
n=21 Participants
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Partial Mayo Score
Baseline
|
5.6 units on a scale
Standard Deviation 1.6
|
|
Partial Mayo Score
Weeks 2
|
2.6 units on a scale
Standard Deviation 2.3
|
|
Partial Mayo Score
Weeks 6
|
2.2 units on a scale
Standard Deviation 2.0
|
|
Partial Mayo Score
Weeks 8
|
1.7 units on a scale
Standard Deviation 1.7
|
|
Partial Mayo Score
Weeks 10
|
2.2 units on a scale
Standard Deviation 2.1
|
|
Partial Mayo Score
Weeks 14
|
1.9 units on a scale
Standard Deviation 1.9
|
|
Partial Mayo Score
Weeks 18
|
2.1 units on a scale
Standard Deviation 1.8
|
|
Partial Mayo Score
Weeks 22
|
2.4 units on a scale
Standard Deviation 2.1
|
|
Partial Mayo Score
Weeks 26
|
1.8 units on a scale
Standard Deviation 1.7
|
|
Partial Mayo Score
Weeks 30
|
2.8 units on a scale
Standard Deviation 1.9
|
|
Partial Mayo Score
The last time point
|
3.7 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30Population: Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.
PUCAI score was determined as a total of the subscores for each of the six evaluation items (0 to 85), including abdominal pain, rectal bleeding, stool consistency of most stools, number of stools per 24 hours, nocturnal stools and activity level. A higher score indicates greater disease activity.
Outcome measures
| Measure |
TA-650
n=21 Participants
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
The last time point
|
28.8 units on a scale
Standard Deviation 22.5
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Baseline
|
47.1 units on a scale
Standard Deviation 15.2
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 2
|
20.3 units on a scale
Standard Deviation 16.3
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 6
|
17.3 units on a scale
Standard Deviation 17.5
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 8
|
12.5 units on a scale
Standard Deviation 13.5
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 10
|
14.7 units on a scale
Standard Deviation 16.9
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 14
|
12.2 units on a scale
Standard Deviation 12.0
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 18
|
14.4 units on a scale
Standard Deviation 16.8
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 22
|
18.2 units on a scale
Standard Deviation 15.6
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 26
|
13.2 units on a scale
Standard Deviation 14.0
|
|
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Weeks 30
|
19.3 units on a scale
Standard Deviation 18.8
|
Adverse Events
TA-650
Serious adverse events
| Measure |
TA-650
n=21 participants at risk
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
9.5%
2/21
|
|
Gastrointestinal disorders
Enterocolitis
|
4.8%
1/21
|
Other adverse events
| Measure |
TA-650
n=21 participants at risk
TA-650 is administered at a dose of 5 mg/kg at Weeks 0, 2 and 6, followed by administration at 8-week intervals at Weeks 14 and 22, based on the evaluation index such as CAI score.
|
|---|---|
|
Infections and infestations
Bronchitis
|
4.8%
1/21
|
|
Infections and infestations
Enteritis infectious
|
9.5%
2/21
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
7/21
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21
|
|
Infections and infestations
Subcutaneous abscess
|
4.8%
1/21
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
9.5%
2/21
|
|
Nervous system disorders
Headache
|
4.8%
1/21
|
|
Eye disorders
Scleritis
|
4.8%
1/21
|
|
Vascular disorders
Vasculitis
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.8%
1/21
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.8%
1/21
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
4.8%
1/21
|
|
Gastrointestinal disorders
Cheilitis
|
4.8%
1/21
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21
|
|
Gastrointestinal disorders
Pancreatitis
|
4.8%
1/21
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21
|
|
General disorders
Chest discomfort
|
4.8%
1/21
|
|
General disorders
Infusion site pain
|
4.8%
1/21
|
|
Investigations
Antinuclear antibody increased
|
4.8%
1/21
|
|
Investigations
Blood pressure decreased
|
4.8%
1/21
|
|
Investigations
Double stranded DNA antibody positive
|
57.1%
12/21
|
|
Investigations
Protein urine present
|
4.8%
1/21
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.8%
1/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER