Comparing subcutaneous and intravenous infliximab for treating inflammatory bowel diseases

The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.

This study is testing if a new way of giving infliximab as an injection under the skin works just as well as the traditional intravenous method for adults with active inflammatory bowel diseases like Crohn's disease and ulcerative colitis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CMC Ambroise Paré (Academic / other)
• Drugs / interventions: infliximab
• Locations: 1 site (Neuilly-sur-Seine)
• Trial ID: NCT06274294 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the pharmacokinetics, efficacy, and safety of CT-P13 administered subcutaneously compared to the intravenous formulation in adult patients with active inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. The study will assess whether the subcutaneous administration is non-inferior to the intravenous method in terms of drug exposure and effectiveness by Week 6. By utilizing a subcutaneous approach, the trial seeks to enhance patient convenience and reduce healthcare resource utilization associated with intravenous infusions. The study is designed for patients who have not responded adequately to conventional therapies and are initiating treatment with infliximab CT-P13.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderately to severely active Crohn's disease or ulcerative colitis who have not responded to previous conventional therapies.

Not a fit: Patients who have not been diagnosed with inflammatory bowel diseases or those who have not received prior conventional therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and efficient treatment option for patients with inflammatory bowel diseases.

How similar studies have performed: While this specific approach has not been tested in IBD patients, similar pharmacokinetic modeling in rheumatoid arthritis has shown promising results for subcutaneous administration of infliximab.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged at least 18 years old.
2. 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)
3. 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.
4. Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging.
5. Initiation of infliximab CT-P13 as part of standard of care.
6. Patient suffering from anal suppuration related to CD can be included.
7. 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.
8. Person affiliated to or beneficiary of a social security plan.
9. ► Inclusion criteria for Women of Childbearing Age:

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).
* Intrauterine device (IUD).
* Practicing true abstinence, defined as: abstaining from heterosexual intercourse when this corresponds to the subject's preferred and usual lifestyle (periodic abstinence \[e.g. calendar method, ovulation method, symptothermal method, post-ovulation methods\] and withdrawal are not acceptable)

  * Inclusion Criteria for Women Not of Childbearing Age:

Women do not need to use contraception during or after treatment with study drug if they are considered not of childbearing age due to one of the following situations:

* Premenopausal women with permanent infertility following hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
* Postmenopausal women
* Age \> 55 years without menstruation for 12 months or more without alternative medical cause.
* Age ≤ 55 years without menstruation for 12 months or more without alternative medical cause AND a folliculostimulin (FSH) level \> 30 IU/L.

Exclusion Criteria:

1. Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD.
2. 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.
3. 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.
4. 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.
5. Patients with a positive interferon-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy.
6. Patients with moderate or severe heart failure (NYHA class III/IV).
7. 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.
8. Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Where this trial is running

Neuilly-sur-Seine

• Institut des MICI — Neuilly-sur-Seine, France (Recruiting)

Study contacts

• Principal investigator: Yoram Bouhnik, PhD.Med. — Paris IBD Center
• Study coordinator: Angèle Benoit, M.Pharm.

Conditions Inflammatory Bowel Diseases; Crohn's disease; Ulcerative colitis; Infliximab / CT-P13; Intravenous; Subcutaneous; Pharmacokinetics; Efficacy