Trial Outcomes & Findings for Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease (NCT NCT01580670)
NCT ID: NCT01580670
Last Updated: 2026-01-07
Results Overview
Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
TA-650
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Induction Period (Week 0 to 14)
STARTED
|
14
|
|
Induction Period (Week 0 to 14)
COMPLETED
|
14
|
|
Induction Period (Week 0 to 14)
NOT COMPLETED
|
0
|
|
Maintenance Period (Week 14 to 54)
STARTED
|
14
|
|
Maintenance Period (Week 14 to 54)
COMPLETED
|
12
|
|
Maintenance Period (Week 14 to 54)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
TA-650
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Maintenance Period (Week 14 to 54)
Adverse Event
|
1
|
|
Maintenance Period (Week 14 to 54)
Lack of Efficacy
|
1
|
Baseline Characteristics
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Baseline characteristics by cohort
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.9 • n=37 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54Population: 2 patients were discontinued because of an adverse event and a lack of efficacy respectively.
Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Percent of Patients Who Achieved PCDAI Response
Week 2
|
78.6 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 6
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 10
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 14
|
92.9 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 18
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 26
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 30
|
92.9 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 34
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 38
|
91.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 42
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 46
|
91.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 50
|
100.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 54
|
91.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
The last time point
|
85.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI Response
Week 22
|
92.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54Population: 2 patients were discontinued because of an adverse event and a lack of efficacy respectively.
Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
PCDAI Score
Week 2
|
15.71 units on a scale
Standard Deviation 9.63
|
|
PCDAI Score
Week 6
|
8.75 units on a scale
Standard Deviation 6.56
|
|
PCDAI Score
Week 10
|
6.43 units on a scale
Standard Deviation 5.86
|
|
PCDAI Score
Week 22
|
9.11 units on a scale
Standard Deviation 10.68
|
|
PCDAI Score
Week 30
|
10.36 units on a scale
Standard Deviation 10.14
|
|
PCDAI Score
Week 38
|
9.17 units on a scale
Standard Deviation 8.14
|
|
PCDAI Score
Week 42
|
5.00 units on a scale
Standard Deviation 6.03
|
|
PCDAI Score
Week 46
|
8.33 units on a scale
Standard Deviation 8.42
|
|
PCDAI Score
Week 50
|
2.92 units on a scale
Standard Deviation 4.50
|
|
PCDAI Score
Week 0
|
36.43 units on a scale
Standard Deviation 4.78
|
|
PCDAI Score
Week 14
|
7.86 units on a scale
Standard Deviation 8.82
|
|
PCDAI Score
Week 18
|
5.36 units on a scale
Standard Deviation 5.87
|
|
PCDAI Score
Week 26
|
6.25 units on a scale
Standard Deviation 6.63
|
|
PCDAI Score
Week 34
|
5.21 units on a scale
Standard Deviation 5.88
|
|
PCDAI Score
Week 54
|
7.08 units on a scale
Standard Deviation 9.16
|
|
PCDAI Score
The last time point
|
10.18 units on a scale
Standard Deviation 12.03
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54Population: 2 patients were discontinued because of an adverse event and a lack of efficacy respectively.
Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Change From Baseline of PCDAI Score
Week 30
|
-26.07 units on a scale
Standard Deviation 8.86
|
|
Change From Baseline of PCDAI Score
Week 34
|
-30.21 units on a scale
Standard Deviation 7.11
|
|
Change From Baseline of PCDAI Score
Week 38
|
-26.25 units on a scale
Standard Deviation 10.03
|
|
Change From Baseline of PCDAI Score
Week 42
|
-30.42 units on a scale
Standard Deviation 7.37
|
|
Change From Baseline of PCDAI Score
Week 46
|
-27.08 units on a scale
Standard Deviation 9.99
|
|
Change From Baseline of PCDAI Score
Week 50
|
-32.50 units on a scale
Standard Deviation 5.84
|
|
Change From Baseline of PCDAI Score
Week 54
|
-28.33 units on a scale
Standard Deviation 10.08
|
|
Change From Baseline of PCDAI Score
The last time point
|
-26.25 units on a scale
Standard Deviation 10.69
|
|
Change From Baseline of PCDAI Score
Week 2
|
-20.71 units on a scale
Standard Deviation 8.57
|
|
Change From Baseline of PCDAI Score
Week 6
|
-27.68 units on a scale
Standard Deviation 6.24
|
|
Change From Baseline of PCDAI Score
Week 10
|
-30.00 units on a scale
Standard Deviation 6.35
|
|
Change From Baseline of PCDAI Score
Week 14
|
-28.57 units on a scale
Standard Deviation 7.05
|
|
Change From Baseline of PCDAI Score
Week 18
|
-31.07 units on a scale
Standard Deviation 6.63
|
|
Change From Baseline of PCDAI Score
Week 22
|
-27.32 units on a scale
Standard Deviation 9.01
|
|
Change From Baseline of PCDAI Score
Week 26
|
-30.18 units on a scale
Standard Deviation 7.37
|
SECONDARY outcome
Timeframe: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54Population: 2 patients were discontinued because of an adverse event and a lack of efficacy respectively.
Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 2
|
42.9 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 6
|
78.6 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 10
|
71.4 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 34
|
83.3 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 38
|
75.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 42
|
83.3 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 46
|
75.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 50
|
91.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 54
|
75.0 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
The last time point
|
64.3 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 14
|
85.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 18
|
85.7 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 22
|
71.4 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 26
|
78.6 percentage of participants
|
|
Percent of Patients Who Achieved PCDAI-Based Remission Rate.
Week 30
|
64.3 percentage of participants
|
SECONDARY outcome
Timeframe: After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.Population: This table does not include the data after an increased dose of 10 mg/kg. In the case of missing examination values or the case where measurement was impossible due to problems with test samples, the relevant measurement result was treated as a missing value.
Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650.
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Serum TA-650 Concentration
Week 46, 1 hr after end of dose
|
126.13 μg/mL
Interval 100.26 to 176.54
|
|
Serum TA-650 Concentration
Week 50
|
12.04 μg/mL
Interval 3.99 to 25.51
|
|
Serum TA-650 Concentration
Week 54
|
3.62 μg/mL
Interval 0.13 to 9.78
|
|
Serum TA-650 Concentration
Week 0, 1 hr after end of dose
|
91.48 μg/mL
Interval 74.35 to 105.37
|
|
Serum TA-650 Concentration
Week 2, before dose
|
17.47 μg/mL
Interval 8.02 to 26.59
|
|
Serum TA-650 Concentration
Week 6, before dose
|
13.47 μg/mL
Interval 3.33 to 27.89
|
|
Serum TA-650 Concentration
Week 10
|
16.46 μg/mL
Interval 3.92 to 32.5
|
|
Serum TA-650 Concentration
Week 14, before dose
|
4.54 μg/mL
Interval 0.0 to 13.52
|
|
Serum TA-650 Concentration
Week 18
|
14.80 μg/mL
Interval 5.29 to 21.19
|
|
Serum TA-650 Concentration
Week 22, before dose
|
3.03 μg/mL
Interval 0.5 to 7.45
|
|
Serum TA-650 Concentration
Week 22, 1 hr after end of dose
|
104.80 μg/mL
Interval 81.96 to 150.79
|
|
Serum TA-650 Concentration
Week 26
|
10.97 μg/mL
Interval 5.21 to 29.5
|
|
Serum TA-650 Concentration
Week 30, before dose
|
3.75 μg/mL
Interval 0.91 to 11.17
|
|
Serum TA-650 Concentration
Week 34
|
11.55 μg/mL
Interval 3.99 to 24.85
|
|
Serum TA-650 Concentration
Week 38, before dose
|
2.04 μg/mL
Interval 0.0 to 8.38
|
|
Serum TA-650 Concentration
Week 42
|
9.48 μg/mL
Interval 3.36 to 27.46
|
|
Serum TA-650 Concentration
Week 46, before dose
|
1.42 μg/mL
Interval 0.0 to 9.6
|
|
Serum TA-650 Concentration
Week 0, before dose
|
0.0 μg/mL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Until the last time point during the period from administration of the study drug to Week 54Population: The analysis population is overall patients receiving at least one dose of TA-650 5 mg/kg or 10 mg/kg.
Outcome measures
| Measure |
TA-650
n=14 Participants
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
The Percent of the Patients Who Experienced an Adverse Event
|
100 percentage of participants
|
Adverse Events
TA-650
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-650
n=14 participants at risk
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
7.1%
1/14
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.1%
1/14
|
Other adverse events
| Measure |
TA-650
n=14 participants at risk
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|---|---|
|
Infections and infestations
Acute sinusitis
|
7.1%
1/14
|
|
Infections and infestations
Enteritis infectious
|
7.1%
1/14
|
|
Infections and infestations
Folliculitis
|
7.1%
1/14
|
|
Infections and infestations
Gastroenteritis
|
21.4%
3/14
|
|
Infections and infestations
Impetigo
|
7.1%
1/14
|
|
Infections and infestations
Influenza
|
14.3%
2/14
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14
|
|
Infections and infestations
Skin infection
|
7.1%
1/14
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14
|
|
Infections and infestations
Viral infection
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
|
Nervous system disorders
Headache
|
21.4%
3/14
|
|
Eye disorders
Blepharitis
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis allergic
|
7.1%
1/14
|
|
Eye disorders
Eyelid oedema
|
7.1%
1/14
|
|
Cardiac disorders
Atrioventricular dissociation
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
1/14
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
1/14
|
|
Hepatobiliary disorders
Hepatic steatosis
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Eczema
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14
|
|
General disorders
Peripheral swelling
|
7.1%
1/14
|
|
Investigations
Amylase increased
|
7.1%
1/14
|
|
Investigations
Antinuclear antibody increased
|
7.1%
1/14
|
|
Investigations
Double stranded DNA antibody positive
|
50.0%
7/14
|
|
Investigations
Weight increased
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER