Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03977480
• Date of registration: 27/04/2019
• Prospective Registration: Yes
• Primary sponsor: Tianjin Hemay Pharmaceutical Co., Ltd
• Public title: Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis
• Date of first enrolment: August 13, 2019
• Target sample size: 70
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03977480
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xiaowei Liu, M.D.
• Affiliation: XiangYa Hospital CentralSouth University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Willing to participate in the trial and signing the informed consent forms;

- Age =18 years old and =70 years old, male or female;

- Diagnosed as ulcerative colitis (UC) = 3 months at screening with clinical
manifestations and evidence of endoscopy and confirmed by histopathological reports;

- Active ulcerative colitis with full Mayo score = 4 points, and the subscore
"endoscopic findings" in the Mayo endoscopic score within 14 days before randomization
= 2 points;

- UC treatment failure or intolerance (intolerance is defined as the discontinuation of
drug use due to adverse reactions judged by the investigators) experienced by patients
using at least one of the following:

Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA); Oral
administration of corticosteroids; Azathioprine or 6-mercaptopurine; Anti-TNF-a treatment:
infliximab or adalimumab, etc.;

- If the patient is using the following drugs to treat ulcerative colitis at the time of
screening, it is necessary to receive stable treatment during the screening period and
the following requirements during the study period are as follows:

- Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA)
maintaining stable for at least = 2 weeks prior to endoscopy during the screening
period and maintaining stable during the study period; and/or

- Oral administration of low-dose corticosteroids (=25 mg/d prednisolone or equivalent
drug dose) maintaining stable for at least = 2 weeks prior to endoscopy during the
screening period;

- At least one of the following effective contraceptive methods should be adopted for
female patients with fertility and male patients who have not undergone vasectomy
during the entire study period from the date of signing the informed consent to 3
months after the last dose. Acceptable contraceptive methods in this study include: a.
abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined
with male condoms. This measure must be applied at least 30 days prior to the first
administration of investigational drug, otherwise another acceptable method of
contraception must be used; c. intra-uterine device (IUD) combined with male condoms;
d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms;
exceptional circumstances: a) females who have been menopausal for 5 years and more,
and b) surgical sterilization (proof should be provided).

Exclusion Criteria:

- Pregnant or lactating women, or women planning to become pregnant during the study;

- Knownto be allergic to any component of Hemay007 tablets (the main component is
hemay007, and the main excipients are microcrystalline cellulose, pregelatinized
starch, croscarmellose sodium, magnesium stearate);

- Patients with suspected or confirmed Crohn's disease, undiagnosed types of colitis,
fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis or
radioactive colitis based on medical history and endoscopy and/or histological
results;

- Patients with the disease confined to the rectum (ulcerative proctitis) according to
the endoscopy during screening;

- Patients who have undergone surgical treatment for ulcerative colitis or who require
surgery during the study;

- Patientswith evidence of pathogenic intestinal infection;

- Patients receiving the following treatments:

Patients who have used azathioprine/6-mercaptopurine, methotrexate within 7 days before
randomization; Patients who have used cyclosporine, mycophenolate mofetil,
tacrolimus/sirolimus within 4 weeks before randomization; Patients who have used interferon
within 8 weeks before randomization; Patients who have received anti-TNF-a treatment within
8 weeks before randomization; Intravenous corticosteroids or rectal administration of
corticosteroids or rectal administration of 5-ASA within 2 weeks prior to randomization;
Patients who have used thalidomide within 8 weeks before randomization;Patients who have
received antibiotic treatment within 1 week before randomization;

• Patients with positive mycobacterium tuberculosis or potential mycobacterium tuberculosis
infection, i.e. patients conforming to any one of the following definitions will be
excluded: QuantiFERON®-TB Gold (QFT-G) or T-SPOT.TB test positive or purified protein
derivative (PPD) skin test induration result = 5 mm (within 3 months before screening);
Chest imaging examination indicating positive tuberculosis (TB) infection lesion within 3
months prior to screening; History of latent or active TB infection;

- Patients with hemoglobin <8 g/dL or hematocrit <30%, white blood cells <3.0 × 10^9/L
or neutrophils <1.2 × 10^9/L, platelets <100 × 10^09/L at screening;

- Total bilirubin (TBIL), aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) = 2 upper limits of normal (ULN) at screening;

- Glomerular filtration rate (eGFR) = 40 ml/min;

- Patients with hereditary immunodeficiency disease;

- Patients with a history of lymphoproliferative disorders (e.g. EBV-related
lymphoproliferative disorders), or with lymphoma, leukemia, myeloproliferative
disease, multiple myeloma;

- Patients previously receiving drugs or treatment depleting lymphocytes (e.g.
alemtuzumab, alkylating agents (e.g. cyclophosphamide or chlorambucil), total lymph
node radiotherapy, etc.), however, patients can be enrolled if they used rituximab or
other selective B lymphocyte depleting drugs more than one year before screening;

- Lymphocyte apheresis or selective mononuclear granulocyte apheresis was performed
within 12 months before the screening or is planned to be performed during the study;

- The electrocardiogram during the screening period is abnormal and clinically
significant, with the safety risk possibly increasing judged by the investigator;

- Blood donation =500 ml within 2 months before randomization;

- Patients with malignant tumor or with a history of malignancy other than well-treated
or resected basal cell or squamous cell skin cancer;

- Patients with conditions that may affect oral drug absorption, e.g. gastrectomy or
clinically significant diabetes-related gastrointestinal disorders, or specific types
of obesity surgery such as gastric bypass, however, patients only subjected to the
division of the stomach into independent chambers, like gastric banding, will not be
excluded;

- Patients with previous surgery on small intestine or colon and with evidence of
colonic dysplasia o


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Hemay007

Drug: Placebo

Primary Outcome(s)

clinical response [Time Frame: 12-week]

Secondary ID(s)

HM007UC2S01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors