A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-29

Study Completion Date

2019-10-02

Brief Summary

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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).

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Detailed Description

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A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.

Conditions

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Crohn's Disease Ulcerative Colitis (Part 2 Only)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: CT-P13 IV 5 mg/kg

CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks (Part 1)

Group Type ACTIVE_COMPARATOR

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)

Cohort 2: CT-P13 SC 120 mg

CT-P13 SC (Infliximab), 120 mg by SC injection every 2 weeks (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)

Cohort 3: CT-P13 SC 180 mg

CT-P13 SC (Infliximab), 180 mg by SC injection every 2 weeks (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)

Cohort 4: CT-P13 SC 240 mg

CT-P13 SC (Infliximab), 240 mg by SC injection every 2 weeks (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)

Arm 1: CT-P13 SC 120/240 mg

CT-P13 SC (Infliximab), either 120 mg or 240 mg every 2 weeks by SC injection (Part 2)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

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)

Arm 2: CT-P13 IV 5 mg/kg

CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks up to Week 22. CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC (Infliximab) treatment, and further doses with CT-P13 SC were given up to Week 54. (Part 2)

Group Type ACTIVE_COMPARATOR

CT-P13

Intervention Type BIOLOGICAL

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)

Interventions

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CT-P13

CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)

Intervention Type BIOLOGICAL

CT-P13

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)

Intervention Type BIOLOGICAL

CT-P13

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 Type BIOLOGICAL

Other Intervention Names

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Infliximab Infliximab Infliximab Infliximab Infliximab Infliximab

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No