Trial Outcomes & Findings for HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis (NCT NCT01882764)
NCT ID: NCT01882764
Last Updated: 2020-01-13
Results Overview
Clinical remission is defined as a modified Mayo Score ≤2 along with no individual score \>1 AND rectal bleeding score = 0.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
52 weeks
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
HMPL-004 1800 mg/Day
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
Placebo
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
19
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
47
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
HMPL-004 1800 mg/Day
n=46 Participants
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
HMPL-004: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks.
|
Placebo
n=19 Participants
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
Placebo: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 14.01 • n=99 Participants
|
47.8 years
STANDARD_DEVIATION 15.64 • n=107 Participants
|
43.4 years
STANDARD_DEVIATION 14.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Region of Enrollment
Lithuania
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Latvia
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Current Smoker: Yes, No
Yes
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Current Smoker: Yes, No
No
|
43 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race
White
|
41 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race
Black
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Weight
|
80.65 kg
STANDARD_DEVIATION 16.70 • n=99 Participants
|
85.99 kg
STANDARD_DEVIATION 24.29 • n=107 Participants
|
82.21 kg
STANDARD_DEVIATION 19.18 • n=206 Participants
|
|
Height
|
170.87 cm
STANDARD_DEVIATION 9.64 • n=99 Participants
|
173.33 cm
STANDARD_DEVIATION 7.99 • n=107 Participants
|
171.59 cm
STANDARD_DEVIATION 9.20 • n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksClinical remission is defined as a modified Mayo Score ≤2 along with no individual score \>1 AND rectal bleeding score = 0.
Outcome measures
| Measure |
HMPL-004 1800 mg/Day
n=46 Participants
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
Placebo
n=19 Participants
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
|---|---|---|
|
The Proportion of Subjects Achieving Clinical Remission
|
0 Participants
|
0 Participants
|
Adverse Events
HMPL-004 1800 mg/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HMPL-004 1800 mg/Day
n=46 participants at risk
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
Placebo
n=19 participants at risk
Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.
Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
|
Infections and infestations
Bronchitis
|
4.3%
2/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
|
Infections and infestations
URTI
|
4.3%
2/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46 • 56 weeks
|
5.3%
1/19 • 56 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.2%
1/46 • 56 weeks
|
5.3%
1/19 • 56 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • 56 weeks
|
10.5%
2/19 • 56 weeks
|
|
General disorders
Pyrexia
|
2.2%
1/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
|
Nervous system disorders
Headache
|
4.3%
2/46 • 56 weeks
|
0.00%
0/19 • 56 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place