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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

⁃ ► 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.

Locations
Other Locations
France
Institut des MICI
RECRUITING
Neuilly-sur-seine
Contact Information
Primary
Angèle Benoit, M.Pharm.
angele.benoit@institutdesmici.fr
0787518342
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2025-01
Participants
Target number of participants: 130
Treatments
Experimental: SC CT-P13 induction
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.
Other: IV CT-P13 induction
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.
Sponsors
Leads: CMC Ambroise Paré
Collaborators: Paris IBD Center, Celltrion HealthCare France

This content was sourced from clinicaltrials.gov