None listed
Conditions
Interventions
CT-P13 SC: from Week 10, CT-P13 SC 120 mg will be administered every 2 weeks via prefilled syringe (PFS) through Week 54.
Group name:2 Type of group
Placebo SC: from Week 10, Placebo SC (matching volume to CT-P13 SC 120 mg) will be administered every 2 weeks via prefilled syringe (PFS) through Week 54.
Sponsors
CELLTRION, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is male or female aged 18 to 75 years, inclusive. 2. Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points at Screening. 3. Patient with average (of 7 days) daily stool frequency ≥4 points (of Type 6 or Type 7 on the BSFS and/or an average (of 7 days) worst daily abdominal pain of ≥2 points (using 4 point scale) at Screening. 4. Patient who has a SES CD of ≥6 points for ileal-colonic CD or ≥4 points including ulcer score from at least 1 segment for ileal CD or colonic CD at Screening. 5. Patient who has CD, confirmed at any time in the past by radiography, histology, or endoscopy, of at least 3 months’ disease duration prior to the first administration of the study drug (Day 0). 6. Patient who has been treated for active CD but has not responded despite a full and adequate course of therapy with corticosteroids and/or immunosuppressants; or who is intolerant to or has medical contraindications for such therapies. 7. Patient who is receiving a stable dose of the following CD treatments or currently not receiving CD treatment during the specified time frame: • Azathioprine (AZA), 6-mercaptopurine (6-MP) or Methotrexate (MTX) 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 a dose of 6 mg/day or less for at least 4 weeks prior to the first administration of the study drug (Day 0) • 5-Aminosalicylates (5-ASA) or antibiotics (i.e., ciprofloxacin, metronidazole) for at least 4 weeks prior to the first administration of the study drug (Day 0) 8. Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results: • Serum creatinine 50 mL/min (by Cockcroft-Gault formula) • Serum alanine aminotransferase <2.5×ULN • Serum aspartate aminotransferase <2.5×ULN • Serum total bilirubin <2×ULN 9. Patient who has the following clinical hematology results at Screening: • Hemoglobin ≥8.5 g/dL (SI [Système International d´Unites] units: ≥85 g/L or 5.28 mmol/L) • White blood cell count ≥3.5×103 cells/µL (SI units: ≥3.5×109 cells/L) • Neutrophil count ≥1.5×103 cells/µL (SI units: ≥1.5×109 cells/L) • Platelet count ≥100×103 cells/µL (SI units: ≥100×109 cells/L) 10. 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 (ICF) prior to participation in the study. 11. 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 diaph
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives prior to the first administration of the study drug (Day 0). 2. Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD. 3. Patient who has previously received infliximab for treatment of CD or other disease. 4. 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. 5. Patient who has received or has a plan to receive any of following prohibited medications or treatments: • Parenteral corticosteroids for the treatment of CD within 2 weeks prior to the first administration of the study drug (Day 0) • Janus kinase (JAK) inhibitors therapy including but not limited to tofacitinib and baricitinib within 4 weeks prior to the first administration of the study drug (Day 0) • Alkylating agents within 12 months prior to the first administration of the study drug (Day 0) • Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to the first administration of the study drug (Day 0) • Live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 0) • Abdominal surgery for, including but not limited to, active gastrointestinal bleeding, peritonitis, intestinal obstruction, gastrointestinal resection or intra abdominal or pancreatic abscess requiring surgical drainage within 6 months prior to the first administration of the study drug (Day 0) • Nonautologous stem cell therapy (e.g., Prochymal) within 12 months prior to the first administration of the study drug (Day 0) • Apheresis (e.g., Adacolumn apheresis) for the treatment of CD within 3 weeks prior to the first administration of the study drug (Day 0) • Use of total parenteral nutrition within a month prior to the first administration of the study drug (Day 0) • Use of exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 weeks prior to the first administration of the study drug (Day 0) 6. Patient who has a current or history of any of the following infections: • Known infection with hepatitis B or hepatitis C (active or carrier state), or infection with human immunodeficiency virus (HIV). However, a patient who is without cirrhosis of liver and recovered from a past hepatitis B or hepatitis C infection can be enrolled. In case of hepatitis C infection, patient who has achieved a sustained virologic response (SVR) for at least 12 weeks after completing the treatment for hepatitis C infection can be enrolled. • Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 0) • Other serious infection, in the investigator’s opinion, within 6 months prior to the first administration of the study drug (Day 0) • Other chronic or recurrent infection, in the investigator’s opinion, within 6 weeks prior to the first administration of the study drug (Day 0) • Past or current granulomatous infections or opportunistic infections (e.g., herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, or mycobacteria other than TB) or invas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Absolute CDAI score Measure:Efficacy Assessments: Clinical remission at Week 54 Timepoints:At Week 54 ; Outcome name:SES-CD score Measure:Efficacy Assessments: Endoscopic response at Week 54 (50% decrease in SES-CD score from the baseline value) Timepoints:At Week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:CDAI score Measure:Efficacy Assessments: Maintenance of clinical response at Week 54 (CDAI-100 response at Week 54, among the patients in CDAI-100 response at Week 10) Timepoints:At Week 54 ; Outcome name:Average worst daily abdominal pain score and average daily loose/watery stool frequency Measure:Efficacy Assessments: Sustained clinical response at both Week 22 and Week 54 Timepoints:At Week 22 and Week 54 ; Outcome name:Absolute SES-CD score Measure:Efficacy Assessments: Endoscopic remission, (absolute SES-CD score of ≤4 and at least 2-point reduction from the baseline value with no sub-score of >1) Timepoints:At the time points specified in the schedule ; Outcome name:SES-CD score Measure:Efficacy Assessments: Endoscopic response (50% decrease in SES-CD score from the baseline value) Timepoints:At the time points specified in the schedule ; Outcome name:A question that asks a patient’s position on achieving remission from his or her CD symptoms (Yes or No) Measure:Efficacy Assessments: Patient global scale Timepoints:At the time points specified in the schedule ; Outcome name:Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Measure:Efficacy Assessments: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Timepoints:At the time points specified in the schedule ; Outcome name:Ctrough and Cmax Measure:Pharmacokinetic Assessments Timepoints:Up to Week 52 ; Outcome name:C-reactive protein [CRP] and fecal calprotectin Measure:Pharmacodynamic Assessments Timepoints:Prior to study drug administration at the time points specified in the schedule of events ; Outcome name:Adverse Events Measure:Safety Assessments Timepoints:During all study ; Outcome name:CDAI score Measure:Efficacy Assessments: CDAI-100 response at Week 54 | — |
Countries
Austria, Belarus, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Latvia, Mexico, Modalvia, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United States
Contacts
Public ContactElena Camacho
PPD Peru S.A.C.
Outcome results
None listed