Inflammatory Bowel DiseasesPhase 3PASSPORTNCT06274294
Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC
A Phase 3 study testing CT-P13 in people with Inflammatory Bowel Diseases, run by CMC Ambroise Paré at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- CT-P13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2024to Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 23Show fewer
- 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)
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut des MICI
Neuilly-sur-Seine, 92200
Marie-Claude Bassene, 06 42 46 94 57, marie-claude.bassene@institutdesmici.fr
Yoram Bouhnik, Prof.
About this study
Official title: The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.
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.
Read the detailed description
The subcutaneaous formulation of infliximab CT-P13 represents a promising approach in the treatment of inflammatory bowel disease (IBD), with an efficacy/safety/immunogenicity profile similar or even improved compared to the intravenous formulation of CT-P13. For patients, SC administration can offer benefits over their daily activities by reducing the frequency of days spent in the hospital to receive infusions. The SC administration may offer convenience for the healthcare system, optimizing the organizational impact due to the preparation and administration of the IV infusion, allowing resources to be used more efficiently, and reducing direct costs associated with the infusion. There are no clinical trials with Remsima® 120 mg given subcutaneously without IV loading doses of CT-P13 in patients with IBD. However, population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable CT-P13 exposure (AUC over 8 weeks) and efficacy from Week 6 onward in rheumatoid arthritis patients treated with Remsima® 120 mg given without IV loading doses of CT-P13 when compared with Remsima® 3 mg/kg given intravenously at weeks 0, 2 and 6, and then every 8 weeks. For the dosing regimen with subcutaneous loading in patients with rheumatoid arthritis, the predicted median AUC value was 17,400 μg·h/mL from Week 0 to 6 which was approximately 1.8 fold lower than the predicted median AUC value for the dosing regimen with CT-P13 IV loading doses (32,100 μg·h/mL). Whereas the predicted median AUC values from Week 6 to 14 were comparable between the two dosing regimens with SC loading and IV loading (19,600 and 18,100 μg·h/mL, respectively).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- CT-P13
- 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
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13Drug
Induction treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CT-P13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Week 6
Secondary outcomes (10)
Ctrough at week 24 (non-inferiority)
Measured: Week 24
AUC at week 24
Measured: Week 24
Clinical response at week 6 and week 24
- Defined for UC as a decrease of at least 50% in PRO2.
- Defined for CD as a decrease from baseline in CDAI score of at least 100 points or a total CDAI score < 150 and defined as achieving a total HBI < 4
Measured: Weeks 6 and 24
IBD disability index at week 6
Measured: Week 6
Fecal calprotectin at week 24
Measured: Week 24
Clinical remission at week 6 and week 24
- Defined for UC as a symptomatic remission score with a stool frequency subscore of 0 or a subscore of 1 with a decrease of ≥1 point from baseline, and a rectal-bleeding subscore of 0.
- Defined for CD as a CDAI score < 150 evaluated in semi-blind (assessment will be done by another investigator without information on the treatment) and defined as achieving a total HBI < 4.
Measured: Weeks 6 and 24
Presence of antibodies to infliximab at Week 6 and Week 24
Measured: Weeks 6 and 24
Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24)
Measured: Up to Week 6
Adverse events, including injection site reactions and hypersensitivity reactions
Number of participants, number of AEs per patient, number of injection site reactions and hypersensitivity reactions per patient.
Measured: From Baseline up to 6 weeks and 24 weeks
TSQM collected at Week 6 and Week 24
The Treatment Satisfaction Questionnaire for Medication consists of 14 items that results in four specific domains: Effectiveness, Side Effects, Convenience, and one global scale item, Global Satisfaction. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Jul 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Collaborators
- Paris IBD Center, Celltrion HealthCare France
- Responsible party
- Sponsor
- Investigators
- Yoram Bouhnik, PhD.Med., Principal investigator, Paris IBD Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274294
- Sponsor's protocol ID
- 2023/12
- Acronym
- PASSPORT
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33676969Iannone 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.
PubMed 35673354
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT06274294
- Acronym / sponsor ID
- PASSPORT / 2023/12
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, Crohn's disease, Ulcerative colitis, Infliximab / CT-P13, Intravenous, Subcutaneous, Pharmacokinetics, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Collaborators
- Paris IBD Center, Celltrion HealthCare France
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The subcutaneaous formulation of infliximab CT-P13 represents a promising approach in the treatment of inflammatory bowel disease (IBD), with an efficacy/safety/immunogenicity profile similar or even improved compared to the intravenous formulation of CT-P13. For patients, SC administration can offer benefits over their daily activities by reducing the frequency of days spent in the hospital to receive infusions. The SC administration may offer convenience for the healthcare system, optimizing the organizational impact due to the preparation and administration of the IV infusion, allowing resources to be used more efficiently, and reducing direct costs associated with the infusion. There are no clinical trials with Remsima® 120 mg given subcutaneously without IV loading doses of CT-P13 in patients with IBD. However, population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable CT-P13 exposure (AUC over 8 weeks) and efficacy from Week 6 onward in rheumatoid arthritis patients treated with Remsima® 120 mg given without IV loading doses of CT-P13 when compared with Remsima® 3 mg/kg given intravenously at weeks 0, 2 and 6, and then every 8 weeks. For the dosing regimen with subcutaneous loading in patients with rheumatoid arthritis, the predicted median AUC value was 17,400 μg·h/mL from Week 0 to 6 which was approximately 1.8 fold lower than the predicted median AUC value for the dosing regimen with CT-P13 IV loading doses (32,100 μg·h/mL). Whereas the predicted median AUC values from Week 6 to 14 were comparable between the two dosing regimens with SC loading and IV loading (19,600 and 18,100 μg·h/mL, respectively).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SC CT-P13 induction | Experimental | Drug: CT-P13Experimental 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. |
| IV CT-P13 induction | Other | Drug: CT-P13Control 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female, aged at least 18 years old.
- Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P13Induction treatment. | Drug | IV CT-P13 induction, SC CT-P13 induction |
Primary outcome
Ratio SC/IV
Time frame: Week 6
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%.
10 secondary outcomes
Ctrough at week 24 (non-inferiority)
Time frame: Week 24
AUC at week 24
Time frame: Week 24
Clinical response at week 6 and week 24
Time frame: Weeks 6 and 24
IBD disability index at week 6
Time frame: Week 6
Fecal calprotectin at week 24
Time frame: Week 24
Clinical remission at week 6 and week 24
Time frame: Weeks 6 and 24
Presence of antibodies to infliximab at Week 6 and Week 24
Time frame: Weeks 6 and 24
Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24)
Time frame: Up to Week 6
Adverse events, including injection site reactions and hypersensitivity reactions
Time frame: From Baseline up to 6 weeks and 24 weeks
TSQM collected at Week 6 and Week 24
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Results publication: PubMed 33676969Schreiber 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.
- Results publication: PubMed 35673354Iannone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Bouhnik, PhD.Med. principal investigator
Paris IBD Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P13 in people with Inflammatory Bowel Diseases, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angèle Benoit, M.Pharm. (0787518342, angele.benoit@institutdesmici.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio SC/IV (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.