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A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01805791
Recruitment Status : Terminated (Interim futility analysis results)
First Posted : March 6, 2013
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: HMPL-004 1800 mg/day
Drug: Placebo
Drug: HMPL-004 2400 mg/day
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo HMPL-004 1800 mg/Day HMPL-004 2400 mg/Day
Hide Arm/Group Description

Placebo, oral tablets, three times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times daily (total dose 1800 mg/day) for 56 days (8 weeks).

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times per day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times daily (total dose 2400 mg/day) for 56 days (8 weeks).

Period Title: Overall Study
Started 66 67 68
Completed 44 50 48
Not Completed 22 17 20
Arm/Group Title Placebo HMPL-004 1800 mg/Day HMPL-004 2400 mg/Day Total
Hide Arm/Group Description

Placebo, oral tablets, 3 times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks).

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks).

Total of all reporting groups
Overall Number of Baseline Participants 66 67 68 201
Hide Baseline Analysis Population Description
Demographics and baseline characteristics are summarized in the Safety Population, by treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 67 participants 68 participants 201 participants
45.3  (16.32) 43.9  (15.07) 40.6  (12.33) 43.2  (14.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 67 participants 68 participants 201 participants
Female
23
  34.8%
37
  55.2%
33
  48.5%
93
  46.3%
Male
43
  65.2%
30
  44.8%
35
  51.5%
108
  53.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 67 participants 68 participants 201 participants
Hispanic or Latino
9
  13.6%
9
  13.4%
10
  14.7%
28
  13.9%
Not Hispanic or Latino
57
  86.4%
58
  86.6%
58
  85.3%
173
  86.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 67 participants 68 participants 201 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.5%
0
   0.0%
2
   2.9%
3
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.0%
3
   4.5%
9
  13.2%
14
   7.0%
White
62
  93.9%
63
  94.0%
55
  80.9%
180
  89.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.5%
1
   1.5%
2
   2.9%
4
   2.0%
Current Smoker: Yes, No  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 67 participants 68 participants 201 participants
Yes
6
   9.1%
4
   6.0%
1
   1.5%
11
   5.5%
No
60
  90.9%
63
  94.0%
67
  98.5%
190
  94.5%
Weight, Continuous  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 66 participants 67 participants 68 participants 201 participants
80.94  (16.00) 79.77  (19.35) 82.24  (21.42) 80.99  (19.01)
Height, Continuous  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 66 participants 67 participants 68 participants 201 participants
172.21  (10.30) 170.67  (9.54) 170.28  (8.74) 171.05  (9.53)
1.Primary Outcome
Title Percentage of Subjects With a Clinical Remission at Week 8
Hide Description Clinical remission was defined as a total Mayo Score of ≤2 points with no individual sub-score >1 point and rectal bleeding score = 0.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.
Arm/Group Title HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Hide Arm/Group Description:

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks).

Placebo, oral tablets, 3 times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks).

Overall Number of Participants Analyzed 57 58 52
Measure Type: Count of Participants
Unit of Measure: Participants
9
  15.8%
7
  12.1%
9
  17.3%
2.Secondary Outcome
Title The Proportion of Subjects With Clinical Response at Week 8
Hide Description Clinical response was defined as a decrease in a modified Mayo Score from baseline by ≥3 points and ≥30% decrease in the modified Mayo Score, along with either a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.
Arm/Group Title HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Hide Arm/Group Description:

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks).

Placebo, oral tablets, 3 times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks).

Overall Number of Participants Analyzed 57 58 52
Measure Type: Count of Participants
Unit of Measure: Participants
23
  40.4%
19
  32.8%
16
  30.8%
3.Secondary Outcome
Title The Proportion of Subjects With Mucosal Healing at Week 8
Hide Description Mucosal healing was defined as having normal or inactive disease using a modified Mayo Score to determine if the decrease in the modified Mayo endoscopy sub-score from baseline was ≥1 in at least 1 segment and had an absolute score ≤1 in all segments.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.
Arm/Group Title HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Hide Arm/Group Description:

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks).

Placebo, oral tablets, 3 times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks).

Overall Number of Participants Analyzed 57 58 52
Measure Type: Count of Participants
Unit of Measure: Participants
13
  22.8%
13
  22.4%
14
  26.9%
Time Frame 86 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Hide Arm/Group Description

2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times a day

HMPL-004 2400 mg/day: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg 3 times a day (total dose 2400 mg/day) for 56 days (8 weeks).

1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day

HMPL-004 1800 mg/day: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg 3 times a day (total dose 1800 mg/day) for 56 days (8 weeks).

Placebo, oral tablets, 3 times a day

Placebo: Subjects randomized to the arm of Placebo will receive matching Placebo 3 times a day for 56 days (8 weeks).

All-Cause Mortality
HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/67 (0.00%)   0/66 (0.00%) 
Hide Serious Adverse Events
HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/67 (0.00%)   4/66 (6.06%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage *  0/68 (0.00%)  0/67 (0.00%)  1/66 (1.52%) 
General disorders       
Pyrexia *  0/68 (0.00%)  0/67 (0.00%)  1/66 (1.52%) 
Infections and infestations       
Appendicitis *  0/68 (0.00%)  0/67 (0.00%)  1/66 (1.52%) 
Vascular disorders       
Deep vein thrombosis *  0/68 (0.00%)  0/67 (0.00%)  1/66 (1.52%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
HMPL-004 2400 mg/Day HMPL-004 1800 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/68 (45.59%)   25/67 (37.31%)   21/66 (31.82%) 
Blood and lymphatic system disorders       
Anaemia *  2/68 (2.94%)  1/67 (1.49%)  1/66 (1.52%) 
Gastrointestinal disorders       
Diarrhoea *  4/68 (5.88%)  2/67 (2.99%)  3/66 (4.55%) 
Abdominal pain *  3/68 (4.41%)  1/67 (1.49%)  2/66 (3.03%) 
Nausea *  2/68 (2.94%)  2/67 (2.99%)  4/66 (6.06%) 
Rectal hemorrhage *  3/68 (4.41%)  1/67 (1.49%)  0/66 (0.00%) 
Vomiting *  3/68 (4.41%)  1/67 (1.49%)  0/66 (0.00%) 
Abdominal pain upper *  3/68 (4.41%)  0/67 (0.00%)  0/66 (0.00%) 
Constipation *  0/68 (0.00%)  2/67 (2.99%)  2/66 (3.03%) 
Dry mouth *  2/68 (2.94%)  0/67 (0.00%)  0/66 (0.00%) 
Dyspepsia *  0/68 (0.00%)  2/67 (2.99%)  1/66 (1.52%) 
Flatulence *  2/68 (2.94%)  0/67 (0.00%)  1/66 (1.52%) 
GERD *  2/68 (2.94%)  0/67 (0.00%)  0/66 (0.00%) 
General disorders       
Fatigue *  2/68 (2.94%)  1/67 (1.49%)  0/66 (0.00%) 
Pyrexia *  2/68 (2.94%)  0/67 (0.00%)  1/66 (1.52%) 
Infections and infestations       
Nasopharyngitis *  2/68 (2.94%)  1/67 (1.49%)  1/66 (1.52%) 
Sinusitis *  2/68 (2.94%)  0/67 (0.00%)  0/66 (0.00%) 
Tooth abscess *  0/68 (0.00%)  2/67 (2.99%)  0/66 (0.00%) 
Gastroenteritis *  0/68 (0.00%)  0/67 (0.00%)  2/66 (3.03%) 
Musculoskeletal and connective tissue disorders       
Back pain *  2/68 (2.94%)  1/67 (1.49%)  0/66 (0.00%) 
Myalgia *  2/68 (2.94%)  1/67 (1.49%)  0/66 (0.00%) 
Arthralgia *  0/68 (0.00%)  2/67 (2.99%)  2/66 (3.03%) 
Nervous system disorders       
Dizziness *  2/68 (2.94%)  2/67 (2.99%)  0/66 (0.00%) 
Dysgeusia *  3/68 (4.41%)  0/67 (0.00%)  0/66 (0.00%) 
Psychiatric disorders       
Depression *  2/68 (2.94%)  1/67 (1.49%)  0/66 (0.00%) 
Insomnia *  2/68 (2.94%)  0/67 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders       
Cough *  0/68 (0.00%)  2/67 (2.99%)  0/66 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash *  2/68 (2.94%)  0/67 (0.00%)  0/66 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rongjun Liu
Organization: Hutchison MediPharma Ltd
Phone: +86 21 2067 3203
EMail: rongjunl@hmplglobal.com
Layout table for additonal information
Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT01805791    
Other Study ID Numbers: HMPL-004-03
First Submitted: March 4, 2013
First Posted: March 6, 2013
Results First Submitted: December 13, 2019
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020