Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis
- Conditions
- Moderately to Severely Active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-003849-15-HR
- Lead Sponsor
- Celltrion, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 615
-Patient is male or female aged 18 to 75 years, inclusive.
-Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of = 2 points at Screening.
-Patient with UC, confirmed by endoscopic or radiographic and histological criteria. Histopathology report supporting the diagnosis must be available in the source documents prior to the first administration of the study drug (Day 0).
-Patient who has been treated for active UC but has not responded despite conventional therapy including corticosteroids alone or in combination with 6-mercaptopurine (6-MP) or azathioprine or who is intolerant to or has medical contraindications to such therapies.
-Patient who is receiving stable doses of the following UC treatments or currently not receiving UC
treatment during specified time frame:
*Azathioprine, or 6-MP, or methotrexate for at least 8 weeks prior to the first administration of the
study drug (Day 0)
*Oral corticosteroids at the equivalent dose of 20 mg/day or less of prednisone for at least 2 weeks
prior to the first administration of the study drug (Day 0)
*Oral budesonide at the dose of 9 mg/day or less at least for 2 weeks prior to the first administration
of the study drug (Day 0)
*Oral 5-ASA for at least 4 weeks prior to the first administration of the study drug (Day 0)
*Antibiotics (e.g., ciprofloxacin, metronidazole) for at least 4 weeks prior to the first administration
of the study drug (Day 0). Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
*Serum creatinine < 1.5×upper limit of normal (ULN) or an estimated creatinine clearance level
> 50 mL/min (by Cockcroft-Gault formula).
*Serum alanine aminotransferase < 2.5×ULN
*Serum aspartate aminotransferase < 2.5×ULN
*Serum total bilirubin < 2×ULN
-Patient who has the following clinical hematology results at Screening:
*Hemoglobin = 8.5 g/dL (SI [Système International d'Unités] units: = 85 g/L or 5.28 mmol/L)
*White blood cell count = 3.5×10 3 cells/µL (SI units: = 3.5×10 9 cells/L)
*Neutrophil count = 1.5×10 3 cells/µL (SI units: = 1.5×10 9 cells/L)
*Platelet count = 100×10 3 cells/µL (SI units: = 100×10 9 cells/L)
-Patient (or legal guardian, if applicable) who is informed of the full nature and purpose of the study,
including possible risks and side effects, has the ability to cooperate with the investigator and is given
ample time and opportunity to read or understand verbal and/or written instructions, and has signed and dated the written informed consent form with date prior to participation in the study.
-For both male and female patients, the patient and his or her partner of childbearing potential who agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
*Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
*Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal
patches, or contraceptive rings)
*Intrauterine device
Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any of medically acceptable methods of contraception. Menopausal fema
-Patient who has previously received 2 or more biologic agents, 2 or more JAK inhibitors or 2 or more both biologic agents and JAK inhibitors
-Patient who has previously received either TNFa inhibitor or biologic agent within 5 half-lives prior to the 1st administration of the IP (Day 0)
-Patient who has previously demonstrated inadequate response or intolerance to TNFa inhibitors
-Patient who has previously received infliximab
-Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or has a hypersensitivity to immunoglobulin products
-Patient who has received or has a plan to receive: parenteral corticosteroids for the treatment of UC within 2 wks prior to the 1st administration of IP, rectally administered medications containing corticosteroids or 5-ASA for the treatment of UC within 2 wks prior to the 1st administration of the IP, JAK inhibitors including within 4 wks prior to the 1st administration of IP, alkylating agents within 12 mths prior to the 1st administration of IP, cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 8 wks prior to the 1st administration of IP, live or live-attenuated vaccine within 4 wks prior to the 1st administration of IP, abdominal surgery within 6 mths prior to the 1st administration of IP, nonautologous stem cell therapy within 12 mths prior to the 1st administration of IP, apheresis for the treatment of UC within 3 wks prior to the 1st administration of IP, total parenteral nutrition within a month prior to the 1st administration of IP, exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 wks prior to the 1st administration of IP
-Patient who has a current or history infections: hepatitis B or hepatitis C (active or carrier state) or infection with HIV), acute infection requiring oral antibiotics within 2 wks or parenteral injection of antibiotics within 4 wks prior to the 1st administration of IP, other serious infection within 6 mths prior to the 1st administration of IP, other chronic or recurrent infection within 6 wks prior to the 1st
administration of IP, past or current granulomatous infections or opportunistic infections or invasive fungal infection, infection with Clostridium difficile toxin within 3 mths prior to the 1st administration
of IP, positive stool examinations for enteric pathogens, pathogenic ova or parasites
-Patient who has a medical condition including 1 or more of the following:
*Ulcerative colitis limited to only the rectum or to less than 15 cm of the colon
*Evidence of toxic megacolon
*Diagnosed with Crohn’s Disease or indeterminate colitis
*Extensive colonic resection prior to the first administration of IP
*Evidence of fixed symptomatic stenosis or obstruction of the large intestine
*Evidence of colonic mucosal dysplasia or adenomatous polyps. ?
*Currently require or are anticipated to require surgical intervention for UC during the study
*Stoma (e.g., ileostomy or colostomy) within 6 months prior to the first administration of the study
drug (Day 0)
*Body mass index = 35 kg/m 2
*Uncontrolled diabetes mellitus, even after insulin treatment
*Uncontrolled hypertension (as defined by systolic blood pressure = 160 mmHg or diastolic blood
pressure = 100 mmHg)
*A known malignancy within 5 years prior to the first administration of the study drug (Day 0), except completely excised and cured squamous carc
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