A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE SUBCUTANEOUS INJECTION OF CT-P13 (CT-P13 SC) AS MAINTENANCE THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE
- Conditions
- -K509 Crohn´s disease, unspecifiedCrohn´s disease, unspecifiedK509
- Registration Number
- PER-022-19
- Lead Sponsor
- CELLTRION, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
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 <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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Absolute CDAI score<br>Measure:Efficacy Assessments:<br>Clinical remission at Week 54<br><br>Timepoints:At Week 54<br>;<br>Outcome name:SES-CD score<br>Measure:Efficacy Assessments:<br>Endoscopic response at Week 54 (50% decrease in SES-CD score from the baseline value)<br><br>Timepoints:At Week 54<br>
- Secondary Outcome Measures
Name Time Method