A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine
- Conditions
- active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 pointsMedDRA version: 9.1Level: LLTClassification code 10066678Term: Acute ulcerative colitis
- Registration Number
- EUCTR2007-005166-12-DE
- Lead Sponsor
- Hutchison MediPharma Enterprises Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
1) Have active confirmed mild to moderate ulcerative colitis defined by a Mayo score 4-10, and with activity confirmed by study colonoscopy or sigmoidoscopy within 2 weeks prior to study entry.
2) Minimum Mayo endoscopy score of =1 at the time of study colonoscopy or sigmoidoscopy.
3) Age = 18 years
4) Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
5) Female patients must be of non-childbearing potential defined as meeting at least one of the following criteria:
• Age = 50 years and naturally amenorrhoeic for = 1 year*.
• Premature ovarian failure confirmed by a specialist gynaecologist.
• Previous bilateral salpingo-oophorectomy, or hysterectomy.
• XY genotype, Turner’s syndrome, uterine agenesis.
*Amenorrhoea following cancer therapy does not rule out childbearing potential.
Fertile male and their partners must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one, contraceptive patch, or condom with spermicide during the study participation and within 3 months thereafter.
6) Show evidence of a personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial
7) May be on Mesalamine (or equivalent medications sulfasalazine, balsalazide, olsalazine) if they have been on it for at least 4 weeks prior to randomization, and the dose has been stable for = 2 weeks prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
1) Have active confirmed mild to moderate ulcerative colitis defined by a Mayo score 4-10, and with activity confirmed by study colonoscopy or sigmoidoscopy within 2 weeks prior to study entry.
2) Minimum Mayo endoscopy score of =1 at the time of study colonoscopy or sigmoidoscopy.
3) Age = 18 years
4) Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
5) Female patients must be of non-childbearing potential defined as meeting at least one of the following criteria:
• Age = 50 years and naturally amenorrhoeic for = 1 year*.
• Premature ovarian failure confirmed by a specialist gynaecologist.
• Previous bilateral salpingo-oophorectomy, or hysterectomy.
• XY genotype, Turner’s syndrome, uterine agenesis.
*Amenorrhoea following cancer therapy does not rule out childbearing potential.
Fertile male and their partners must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one, contraceptive patch, or condom with spermicide during the study participation and within 3 months thereafter.
6) Show evidence of a personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial
7) May be on Mesalamine (or equivalent medications sulfasalazine, balsalazide, olsalazine) if they have been on it for at least 4 weeks prior to randomization, and the dose has been stable for = 2 weeks prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Diagnosed with Crohn’s Disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope which would be suspicious for Crohn’s disease, or with a diagnosis of indeterminant colitis;
2) Severe disease with an ulcerative colitis Mayo Clinical score above 10 points at baseline.
3) Positive stool test for pathogens on any one of three samples taken within the previous 2 weeks prior to study entry.
4) Toxic megacolon or toxic colitis
5) Probable requirement for intestinal surgery within 12 weeks after the start of study medication
6) Receiving oral or rectal steroids within 1 month prior to study entry.
7) Receiving rectal Mesalamine within one week prior to study entry
8) Receiving Azathioprine, 6 MP, or other immunosuppressive therapy including anti-TNF-a agents at the time of screening or within the preceding 6 weeks.
9) Receiving other investigational drugs or biologics within 1 month.
10) Receiving antibiotics within 2 week of study entry
11) Hemoglobin concentration < 9 g/dl
12) WBC below 3,000/cmm, or platelets below 100,000/cmm
13) SGOT, SGPT, alkaline phosphatase >2.5 upper limit of normal
14) Serum creatinine >1.5 times upper limit of normal
15) Significant concurrent medical diseases including: active peptic ulcer disease; uncompensated congestive heart disease; myocardial infarction within the last 12 months; unstable angina pectoris; uncontrolled hypertension; pulmonary disease requiring oxygen therapy.
16) Chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative) or any history of Hepatitis C.
17) Previous colonic surgery except for simple polypectomy.
18) History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, in situ cervical cancer and surgically removed colon polyps.
19) Women who are pregnant or breast feeding ;
20) Patients known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder
21) Patients with a history of tuberculosis or exposure to tuberculosis, or a history of a chest X ray suspicious for tuberculosis, unless shown to be PPD negative.
22) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure;
23) Known allergy to plants of the Acanthaceae family;
24) Unwillingness to participate in the study;
25) Any underlying medical condition that in the Investigator’s opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
;
1) Diagnosed with Crohn’s Disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope which would be suspicious for Crohn’s disease, or with a diagnosis of indeterminant colitis;
2) Severe disease with an ulcerative colitis Mayo Clinical score above 10 points at baseline.
3) Positive stool test for pathogens on any one of three samples taken within the previous 2 weeks prior to study entry.
4) Toxic megacolon or toxic colitis
5) Probable requirement for intestinal surgery within 12 weeks after the start of study medication
6) Receiving oral or rectal steroids within 1 month prior to study entry.
7) Receiving rectal Mesalamine within one week prior to study entry
8) Receiving Azathioprine, 6 MP, or other immunosuppressive therapy including anti-TNF-a agents at the time of screening or within the preceding 6 weeks.
9) Receiving other investigational drugs or biologics within 1 month.
10) Receiving antibiotics within 2 week of study entry
11) Hemoglobin concentration < 9 g/dl
12) WBC below 3,000/cmm, or platelets below 100,000/cmm
13) SGOT, SGPT, alkaline phosphatase >2.5 upper limit of normal
14) Serum creatinine >1.5 times upper limit of normal
15) Significant concurrent medical diseases including: active peptic ulcer disease; uncompensated congestive heart disease; myocardial infarction within the last 12 months; unstable angina pectoris; uncontrolled hypertension; pulmonary disease requiring oxygen therapy.
16) Chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative) or any history of Hepatitis C.
17) Previous colonic surgery except for simple polypectomy.
18) History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, in situ cervical cancer and surgically removed colon polyps.
19) Women who are pregnant or breast feeding ;
20) Patients known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder
21) Patients with a history of tuberculosis or exposure to tuberculosis, or a history of a chest X ray suspicious for tuberculosis, unless shown to be PPD negative.
22) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure;
23) Known allergy to plants of the Acanthaceae family;
24) Unwillingness to participate in the study;
25) Any underlying medical condition that in the Investigator’s opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method