Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.
This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Matching dose of placebo will be given orally in capsules three times per day for 56 days. |
|
| HMPL-004 low dose | Experimental | A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
|
| HMPL-004 high dose | Experimental | A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-004 low dose | Drug | HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Response at Week 8 | Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Remission at Week 8 | The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score >1) at week 8. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were required to have mild to moderate ulcerative colitis to enter the study. Study was conducted at medical clinics and hospitals in the United States, Ukraine and Romania.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Dose HMPL-004 (1800 mg/Day) | HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day. |
| FG001 | Low Dose HMPL-004 (1200 mg/Day) | HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| FG002 | Placebo | Placebo, t.i.d. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The demographic characteristics of the ITT population, all 224 subjects but 1 were included, are summarized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Dose HMPL-004 (1800 mg/Day) | HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day. |
| BG001 | Low Dose HMPL-004 (1200 mg/Day) | HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Clinical Response at Week 8 | Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome. | Based on number of subjects with a non-missing value in each treatment group. | Posted | Count of Participants | Participants | 8 weeks |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose HMPL-004 (1200 mg/Day) | HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rongjun Liu | Hutchison Medipharma | +86 21 2067 3203 | rongjunl@hmplglobal.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713167 | Andrographis paniculata extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching dose of Placebo |
|
| HMPL-004 high dose | Drug | HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day). |
|
|
| 8 weeks |
| Number of Participants With Mucosal Healing at Week 8 | The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome. | 8 weeks |
| BG002 | Placebo | Placebo, t.i.d. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | High Dose HMPL-004 (1800 mg/Day) | HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day. |
| OG002 | Placebo | Placebo, t.i.d. |
|
|
| Secondary | Number of Participants With a Clinical Remission at Week 8 | The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score >1) at week 8. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome. | Based on number of subjects with a non-missing value in each treatment group. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Number of Participants With Mucosal Healing at Week 8 | The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome. | Based on number of subjects with a non-missing value in each treatment group. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 75 |
| 2 |
| 75 |
| 45 |
| 75 |
| EG001 | High Dose HMPL-004 (1800 mg/Day) | HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day. | 0 | 74 | 2 | 74 | 39 | 74 |
| EG002 | Placebo | Placebo, t.i.d. | 0 | 75 | 2 | 75 | 45 | 75 |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Gamma-glutamyl transferase increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Basophilia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |