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Crohn's DiseaseCHAMELEONNCT06064864

Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD

A study testing Infliximab-Dyyb in people with Crohn's Disease, run by Asan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority trial is to test efficacy and safety of formulation switching between subcutaneous (SC) infliximab and intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease (CD). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Crohn's Disease
What is being tested?
Infliximab-Dyyb
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
9 Oct 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Moderate to severe Crohn's disease (Crohn's disease activity index 220 to 450)
  • Ileocolonic Crohn's disease (CD) with Simple Endoscopic Score for Crohn Disease ≥6 or ileal or colonic CD with with Simple Endoscopic Score for Crohn Disease ≥4 and ulcer score ≥1 in at least one segment
  • Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL
  • Patients who have never been to exposed to any biologic agent
  • Patients who are non-responsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy
  • Patients who gave a voluntary informed consent

Who cannot join

  • Patients who have a history of hypersensitivity to humanized proteins
  • Patients ever treated with corticosteroids within 8 weeks of screening date
  • a) Symptomatic intestinal stricture, b) Symptomatic anal stricture, c) Untreated intra-abdominal abscess, d) Untreated perianal abscess, e) Abdominal surgery within 6 months, f) Patients who are expected to require intestinal surgeries during study period
  • However, the following patients can be included: from baseline, 4 weeks or more after proper drainage of perianal abscess and from baseline, 8 weeks or more after proper drainage of intra-abdominal abscess
  • Active tuberculosis. However, the following patients can be included: Patients who were diagnosed with tuberculosis, but were properly treated with anti-tuberculosis therapy according to the standard guidelines and who were confirmed to be cured.
  • Latent tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray, PPD (Purified Protein Derivative) skin test or interferon gamma release assay (IGRA) by a pulmonology specialist. However, patients with LTBI who finished proper treatment for LTBI for 4 weks and who are going to complete LTBI treatment.
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  • HBsAg (Hepatitis B virus surface antigen)-positivity. Patients with negative HBsAg, but positive IgG anti-HBc (Immunoglobulin G anti-Hepatitis B core antibody) should be tested for HBV (hepatitis B virus) DNA real time quantitative PCR (polymerase chain reaction). If HBV DNA real time quantitative PCR ≥10 IU/mL should be excluded.
  • Anti-HCV (hepatitis C virus) antibody-positivity
  • History of HIV (human immunodeficiency virus) infection of positivity for anti-HIV
  • Heart disease of NYHA (New York Heart Association) Class III/IV
  • Active infection
  • Malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) or history of colonic or small bowel dysplasia within 5 years
  • Pregnancy or lactating woman
  • Patients who are not applying proper contraceptive measures and patients who do not have a plan for proper contraceptive measures for at least 6 months after the last dose of infliximab (oral, parenteral, or implantable hormonal contraceptives, diaphragm, condom, intra-uterine device, or abstinence are accepted as proper contraceptive methods.
  • Patients who are decided to be not proper to be enrolled into the study by investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Byong Duk Ye, MD, PhD contact

82-2-3010-3181

bdye@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, 05505

    Byong Duk Ye, MD, PhD, 82-2-3010-3181, bdye@amc.seoul.kr

    Eun Ja Youn, RN, 82-2-3010-8298, eunja.soul@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease

The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority trial is to test efficacy and safety of formulation switching between subcutaneous (SC) infliximab and intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease (CD). The primary endpoint of this study is deep remission at week 54. The main questions this study aims to answer are:

Question-1) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (5mg/kg every 8 weeks) in terms of deep remission at week 54? Question-2) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (10mg/kg every 8 weeks) in terms of deep remission at week 54?

Read the detailed description

Remsima (CT-P13) is the first biosimilar of infliximab and its intravenous (IV) formulation has been used for patients with active Crohn's disease (CD).

Recently, subcutaneous (SC) formulation of Remsima (Remsima SC) was developed and approved by the Korean FDA (Food and Drug Administration). However, until now, besides a registration trial, real-life experiences of Remsima SC is still limited and the efficacy and safety of switching from SC to IV Remsima is still unknown.

In this study, patients with moderately to severely active CD who achieve clinical response to SC Remsima at week 30 (IV Remsima 5mg/kg at week 0 and 2, followed by SC Remsima 120mg every 2 weeks from week 6) will be randomly (1:1) assigned to IV Remsima group (Arm 2) or to continued SC Remsima group (Arm 3). Non-responders at week 30 will be allocated to Arm 1 (IV Remsima 10 mg/kg). The primary endpoint is the non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate at week 54. The secondary endpoint is the non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate at week 54. The non-inferiority margin is set as -20% and a total of 100 patients will be enrolled.

Through this study, the investigators aim to provide the clinical evidence for selecting the most optimal formulation of infliximab according to therapeutic response among Korean patients with CD.

Conditions
Crohn's Disease
Being tested
Infliximab-Dyyb
Keywords
Crohn's disease, Infliximab, Biosimilar, Remsima, Subcutaneous, Intravenous
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infliximab-DyybDrug

    Also called Infliximab

    Continued infliximab SC 120 mg every other week, if response to SC infliximab at week 30

Study groups in NCT06064864
Study groupRoleWhat they receive
Non-response to SC infliximab at week 30 and switched to infliximab IV 10 mg/kg every 8 weeksExperimentalPatients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 1] Non-responders at week 30: Switched to infliximab IV 10 mg/kg every 8 weeks
Receives: Drug: Infliximab-Dyyb
Response to SC infliximab at week 30 and then, switched to infliximab IV 5 mg/kg every 8 weeksExperimentalPatients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 2] Response to SC infliximab at week 30 and then, randomly allocated to infliximab IV 5 mg/kg every 8 weeks
Receives: Drug: Infliximab-Dyyb
Response to SC infliximab at week 30 and then, continued infliximab SC 120 mg every 2 weeksActive comparatorPatients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 3] Response to SC infliximab at week 30 and then, randomly allocated to infliximab SC 120 mg every 2 weeks
Receives: Drug: Infliximab-Dyyb

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deep remission rate of Arm 3 compared with Arm 2

    Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index) <150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation.

    CDAI can range from 0 to 600 and a higher value mean more clinically active disease.

    SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity.

    The non-inferiority of Arm 3 compared with Arm 2 will be test and the non-inferiority margin will be set as "-20%".

    Measured: Week 54

Secondary outcomes (9)

  1. Deep remission rate of Arm 3 compared with Arm 1

    Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index)<150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation.

    CDAI can range from 0 to 600 and a higher value mean more clinically active disease.

    SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity.

    The non-inferiority of Arm 3 compared with Arm 1 will be test and the non-inferiority margin will be set as "-20%".

    Measured: Week 54

  2. Corticosteroid-free endoscopic remission rate of each arm

    All of these 2 criteria should be met to be classified as a corticosteroid-free endoscopic remitter: (1) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (2) No systemic corticosteroids use for at least 8 weeks before evaluation SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity.

    Measured: Week 54

  3. Corticosteroid-free complete mucosal healing rate of each arm

    All of these 2 criteria should be met to be classified as an achiever of corticosteroid-free complete mucosal healing: (1) No visible ulcers (including aphthous ulcers) in ileocolonoscopy, (2) No systemic corticosteroids use for at least 8 weeks before evaluation

    Measured: Week 54

  4. Corticosteroid-free clinical response (CDAI-70) rate of each arm

    All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-70): (1) Reduction of CDAI (Crohn's disease activity index) 70 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.

    Measured: Week 54

  5. Corticosteroid-free clinical response (CDAI-100) rate of each arm

    All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-100): (1) Reduction of CDAI (Crohn's disease activity index) 100 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.

    Measured: Week 54

  6. Corticosteroid-free clinical remission rate of each arm

    All of these 2 criteria should be met to be classified as a corticosteroid-free clinical remitter: (1) CDAI (Crohn's disease activity index) < 150, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.

    Measured: Week 54

  7. Corticosteroid-free biochemical remission rate of each arm

    All of these 2 criteria should be met to be classified as a biochemical remitter: (1) Both fecal calprotectin<250 µg/g and serum CRP (C-reactive protein) <0.5 mg/dL, (2) No systemic corticosteroids use for at least 8 weeks before evaluation

    Measured: Week 54

  8. Rate of anti-drug antibody positivity in each arm

    Proportion of patients with a positive anti-infliximab antibody compared with the baseline

    Measured: Week 54

  9. The proportion of patients with treatment-related adverse events

    Comparing the proportions of patients having any adverse events, serious adverse events, serious infections, and all types of adverse events as assessed by CTCAE v6.0

    Measured: Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start9 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
In this study, CD (Crohn's disease) patients who achieved clinical response at week 30 after to Remsima (CT-P13, a biosimilar of infliximab) SC (subcutaneous formulation) will be randomly (1:1) assigned to intravenous infliximab (Remsima) group (Arm 2) or to continued infliximab (Remsima) SC group (Arm 3). The primary endpoint of the study is the non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate at week 54. Non-responder at week 30 will be allocated to Arm 1 (intravenous infliximab \[Remsima\] 10 mg/kg) and the secondary endpoint is the non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate at week 54. Through this study, the investigators aim to provide the clinical evidence for selecting the most optimal formulation of infliximab according to therapeutic response among Korean patients with CD.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064864
Sponsor's protocol ID
20220644
Acronym
CHAMELEON
Status last verified
May 2024
First submitted
10 Sep 2023
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.

    PubMed 30929895

  • 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 33676969

  • Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.

    PubMed 23856361

Questions about this trial

What is this clinical trial studying?

A study testing Infliximab-Dyyb in people with Crohn's Disease, run by Asan Medical Center at 1 site in South Korea.

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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 14 May 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 South Korea. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Byong Duk Ye, MD, PhD (82-2-3010-3181, bdye@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deep remission rate of Arm 3 compared with Arm 2 (time frame: Week 54). 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 NCT06064864, which also lists 3 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 14 May 2024.

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