A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Condition: Crohn's Disease; Ulcerative Colitis (Part 2 Only)
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: CT-P13; CT-P13; CT-P13; CT-P13; CT-P13; CT-P13
Intervention description: CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1); CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1); CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1); CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1); CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2); CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
Intervention MeSH terms: Infliximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate
      efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous
      (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has active Crohn's disease with a score on the Crohn's disease activity index
             between 220 and 450 points.

          -  Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and
             12 points (Part 2 only).

        Exclusion Criteria:

          -  Patient who has previously received a biological agent for the treatment of CD and UC
             and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other
             disease

          -  Patient who has allergies to any of the excipients of infliximab or any other murine
             and/or human proteins or patient with a hypersensitivity to immunoglobulin product

          -  Patient who has a current or past history of infection with HIV, hepatitis B, or
             hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into
             the study, but past hepatitis B resolved can be enrolled)

          -  Patient who has 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, other serious infection within 6 months prior to the first
             administration of study drug or recurrent herpes zoster or other chronic or recurrent
             infection within 6 weeks prior to the first administration of the study drug

          -  Patient who has an indeterminate result for interferon-γ release assay (IGRA) or
             latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at
             Screening, 1 retest will be possible during the screening. If the repeated IGRA result
             is negative, the patient can be included in the study.