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

NCT02883452 | Completed Phase 1 Results DMC

• 2 other identifiers: CT-P13 1.6 (SC)2016-002124-89
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Crohn's Disease; Ulcerative Colitis (Part 2 Only)

Outcome Measures

Primary Outcomes (2)

• Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)

  For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.

  Week 22, 24, 26 and 28

• Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)

  For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).

  Week 22

Secondary Outcomes (6)

• Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)

  up to Week 54

• Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)

  up to Week 54

• Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)

  up to Week 54

• Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)

  up to Week 54

• Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)

  up to Week 54

Study Arms (6)

Cohort 1: CT-P13 IV 5 mg/kg

ACTIVE COMPARATOR

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

Biological: CT-P13

Cohort 2: CT-P13 SC 120 mg

EXPERIMENTAL

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

Biological: CT-P13

Cohort 3: CT-P13 SC 180 mg

EXPERIMENTAL

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

Biological: CT-P13

Cohort 4: CT-P13 SC 240 mg

EXPERIMENTAL

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

Biological: CT-P13

Arm 1: CT-P13 SC 120/240 mg

EXPERIMENTAL

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

Biological: CT-P13

Arm 2: CT-P13 IV 5 mg/kg

ACTIVE COMPARATOR

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)

Biological: CT-P13

Interventions

CT-P13 BIOLOGICAL

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

Also known as: Infliximab

Cohort 1: CT-P13 IV 5 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Related Publications (2)

• D'Haens G, Reinisch W, Schreiber S, Cummings F, Irving PM, Ye BD, Kim DH, Yoon S, Ben-Horin S. Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial. Clin Drug Investig. 2023 Apr;43(4):277-288. doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1.

  PMID: 37004656 DERIVED

• Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.

  PMID: 33676969 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

CT-P13; Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: SungHyun Kim
• Organization: Celltrion, Inc.

sunghyun.kim@celltrion.com

+82 32 850 5778

Study Officials

• MoonSun Choi

  Celltrion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: September 29, 2016
• Primary Completion: February 4, 2019
• Study Completion: October 2, 2019
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)