Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis

NCT03977480 | Terminated Phase 2

• 1 other identifier: HM007UC2S01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 25

Brief Summary

This study adopts a multicenter, randomized, double-blind, low-medium-high dose group and placebo parallel controlled clinical study design. After screening, patients with active ulcerative colitis who meet the inclusion criteria and do not meet the exclusion criteria will be randomized by 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• clinical response

  12-week clinical response rate Definition of clinical response: defined as full Mayo score decreased by ≥ 3 points compared with baseline and lowered by ≥ 30% compared with baseline, combined with the rectal bleeding subscore decreased by ≥ 1 point compared with baseline, or the absolute value of rectal bleeding subscore ≤ 1 point.

  12-week

Study Arms (4)

Hemay007 400 mg BID group

ACTIVE COMPARATOR

Patients will orally take Hemay007 tablets 400 mg BID for 12 weeks.

Drug: Hemay007

Hemay007 800 mg QD group

ACTIVE COMPARATOR

Patients will orally take Hemay007 tablets 800 mg QD for 12 weeks.

Drug: Hemay007

Hemay007 600 mg BID group

ACTIVE COMPARATOR

Patients will orally take Hemay007 tablets 600 mg BID for 12 weeks.

Drug: Hemay007

placebo group

PLACEBO COMPARATOR

Patients will orally take placebo tablets for 12 weeks.

Drug: Placebo

Interventions

Hemay007 DRUG

Hemay007 will be orally administered.

Hemay007 400 mg BID group; Hemay007 600 mg BID group; Hemay007 800 mg QD group

Placebo DRUG

Placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-α 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).

You may not qualify if:

• 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-α 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;

Sponsors & Collaborators

• Tianjin Hemay Pharmaceutical Co., Ltd: lead

Study Sites (25)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Army Special Medical Center

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Army Military Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Zhengzhou People's Hospital

Zhengzhou, Henan, China

Location

Tongji hospital, tongji medical college, huazhong university of science and technology

Wuhan, Hubei, China

Location

XiangYa Hospital CentralSouth University

Changsha, Hunan, China

Location

Gulou Hospital Affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Neimenggu, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Neimenggu, China

Location

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Xiaowei Liu, M.D.

  XiangYa Hospital CentralSouth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: June 6, 2019
• Study Start: August 13, 2019
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)