Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC

NCT06274294 | Recruiting Phase 3

• 1 other identifier: 2023/12
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care. The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Diseases; Crohn's disease; Ulcerative colitis; Infliximab / CT-P13; Intravenous; Subcutaneous; Pharmacokinetics; Efficacy; Safety; AUC; Ctrough; Fecal calprotectin; Antibodies to infliximab; C-reactive protein; TSQM; IBD disability index

Outcome Measures

Primary Outcomes (1)

• Ratio SC/IV

  The ratio (SC/IV) of log-normal means of Ctrough at W6 and its 95% CI. Non inferiority will be considered as demonstrated if the lower limit of the 95%CI is higher than 80%.

  Week 6

Secondary Outcomes (10)

• Ctrough at week 24 (non-inferiority)

  Week 24

• AUC at week 24

  Week 24

• Clinical response at week 6 and week 24

  Weeks 6 and 24

• IBD disability index at week 6

  Week 6

• Fecal calprotectin at week 24

  Week 24

Study Arms (2)

SC CT-P13 induction

EXPERIMENTAL

Experimental arm: SC induction of 240 mg of CT-P13 at week 1, then 120 mg at weeks 2, 3, 4 then every 2 weeks until week 24.

Drug: CT-P13

IV CT-P13 induction

OTHER

Control arm: IV induction of 5 mg/kg of CT-P13 at weeks 1 and 2 then SC (120 mg) every 2 weeks until week 24.

Drug: CT-P13

Interventions

CT-P13 DRUG

Induction treatment.

IV CT-P13 induction; SC CT-P13 induction

Eligibility Criteria

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

You may qualify if:

• Male or female, aged at least 18 years old.
• Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months:
• moderately to severely active CD (Crohn's disease)
• moderately to severely active UC (Ulcerative colitis)
• Patients had received conventional therapy for active UC (corticosteroids alone or in combination with thiopurines and 5-aminosalicylates) or CD (corticosteroids and/or immunomodulators) but had not responded despite an adequate course of therapy.
• Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging.
• Initiation of infliximab CT-P13 as part of standard of care.
• Patient suffering from anal suppuration related to CD can be included.
• Person who has received full information about the organization of the research, who has not objected to his or her participation and to the use of his or her data.
• Person affiliated to or beneficiary of a social security plan.
• Women of childbearing age should consider the use of appropriate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment. Women should choose one of the following methods of contraception:
• Combined hormonal contraception containing estrogen and progesterone (oral, IUD, transdermal, injectable) combined with ovulation inhibition.
• Initiated at least 30 days before Baseline Day 1.
• Progestin-only hormonal contraception (oral, injectable, implantable) associated with ovulation inhibition initiated at least 30 days before the first injection.
• Bilateral tubal occlusion (can be performed by hysteroscopy, provided that hysterosalpingography confirms the success of the procedure).

You may not qualify if:

• Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD.
• Patient who has allergies to any of the excipients of infliximab CT-P13 or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
• Patient who had current or past history of chronic infection with hepatitis C or human immunodeficiency virus (HIV)-1 or -2 or current infection with hepatitis B.
• Patient who had 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.
• Patients with a positive interferon-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy.
• Patients with moderate or severe heart failure (NYHA class III/IV).
• Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: pregnant woman, parturient, or breastfeeding woman, minor person (non-emancipated), adult person under legal protection (any form of public guardianship), adult person incapable of giving consent.
• Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Sponsors & Collaborators

• CMC Ambroise Paré: lead
• Paris IBD Center: collaborator
• Celltrion HealthCare France: collaborator

Study Sites (1)

Institut des MICI

Neuilly-sur-Seine, 92200, France

RECRUITING

Related Publications (2)

• 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 RESULT

• Iannone F, Conti F, Cauli A, Farina A, Caporali R. Subcutaneously-Administered Infliximab in the Management of Rheumatoid Arthritis: A Short Narrative Review of Current Clinical Evidence. J Inflamm Res. 2022 Jun 1;15:3259-3267. doi: 10.2147/JIR.S240593. eCollection 2022.

  PMID: 35673354 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

CT-P13

Condition Hierarchy (Ancestors)

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

Study Officials

• Yoram Bouhnik, PhD.Med.

  Paris IBD Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angèle Benoit, M.Pharm.

CONTACT

0787518342; angele.benoit@institutdesmici.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows: * Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24. * Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 23, 2024
• Study Start: July 10, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)