A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Phase 1

Conditions: lcerative Colitis (UC)
MedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-002116-27-CZ

Lead Sponsor: utrition Science Partners Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

1) Subjects must be currently receiving mesalamine = 2.4 g/day (or the equivalent) for at least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior to entering the screening phase of the study to ensure a stable dose is established at least 2 weeks prior to the
endoscopic procedures.
2) Have active mild to moderate ulcerative colitis defined by a modified Mayo Score 4-10, and with endoscopy score activity of 2-3 points confirmed by a full colonoscopy within 2 weeks prior to randomization. Activity can be in any of the 5 colon segments.
3) Age = 18 years.
4) Subjects have no prior exposure to HMPL-004.
5) Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
6) All fertile male and female subjects must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, and progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one and continues for the duration of the trial, contraceptive patch, or condom with spermicide.
7) 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
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1) Subjects with intolerance or adverse reactions to mesalamine (or equivalent medications).
2) 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 indeterminate colitis.
3) Severe disease with an ulcerative colitis modified Mayo Clinic score above 10 points at baseline.
4) Positive stool test for pathogens for sample taken within the previous 2 weeks prior to study entry.
5) Active Clostridium difficile (C. diff) infection.
6) Use of IBD related herbal supplements including supplements containing andrographis and probiotics two weeks prior to study entry or during the study.
7) Toxic megacolon or toxic colitis.
8) Probable requirement for intestinal surgery within 12 weeks after the start of study medication.
9) Receiving oral or rectal steroids within 1 month prior to study entry.
10) Receiving rectal mesalamine within one week prior to study entry.
11) Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy at the time of screening or within the preceding 6 weeks.
12) Receiving anti-TNF-a agents such as infliximab, adalimumab, golimumab, or certolizumab pegol at the time of screening or within the preceding 8 weeks.
13) Receiving other investigational drugs or biologics within 1 month or five half lives.
14) Receiving antibiotics within 2 weeks of study entry.
15) Hemoglobin concentration < 9 g/dl.
16) WBC below 3,000/ cm3, or platelets below 100,000/ cm3.
17) SGOT, SGPT, alkaline phosphatase >2.5 upper limit of normal.
18) Serum creatinine >1.5 times upper limit of normal.
19) 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.
20) Chronic Hepatitis B any history of Hepatitis C.
21) Previous colonic surgery except for simple polypectomy.
22) History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, and in situ cervical cancer.
23) Subjects with a history of or concurrent colonic dysplasia associated with UC, except those with completely excised sporadic colorectal polyps.
24) Women who are pregnant or breast feeding.
25) Subjects known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder.
26) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
27) Known allergy to plants of the Acanthaceae family.
28) Unwillingness to participate in the study.
29) 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.