Phase 1
Completed N=175
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Crohn's Disease · Ulcerative Colitis (Part 2 Only)
Source: ClinicalTrials.gov NCT02883452 ↗
Enrolled (actual)
175
Serious AEs
13.7%
Results posted
Jun 2020
Primary outcomePrimary: Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) — 20825679.963; 7821587.111; 12609504.125; 9377712.620 hr*ng/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) |
20825679.963; 7821587.111; 12609504.125; 9377712.620; 7409271.434; 6736990.881 | — |
| PRIMARY Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) |
20.9844; 1.8181 | — |
| SECONDARY Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) |
296.38; 294.75; 194.89; 191.03; 164.99; 144.94 | — |
| SECONDARY Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) |
13; 9; 16; 17; 19; 18 | — |
| SECONDARY Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) |
5.4; 5.9; 3.3; 3.3; 2.6; 2.5 | — |
| SECONDARY Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) |
20; 25; 28; 31; 30; 33 | — |
| SECONDARY Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) |
23.5432; 21.8589; 15.4736; 14.0747; 3.7865; 20.9700 | — |
| SECONDARY Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) |
2094.2; 2605.2; 697.0; 455.0; 735.3; 567.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02883452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.