Crohn's Disease study: Infliximab-Dyyb
Official title Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
ClinicalTrials.gov ID: NCT06064864
What this study is testing
What is Infliximab-Dyyb?
Infliximab-Dyyb is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn's disease.
Also referred to as Infliximab.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving infliximab as a subcutaneous injection every two weeks is not worse than the usual intravenous infusion for achieving deep remission after about a year.
- Who it's for
- Adults who have moderately to severely active Crohn's disease.
- What's involved
- Participants will receive either a subcutaneous injection of infliximab (120 mg every 2 weeks) or an intravenous infusion (5 mg/kg or 10 mg/kg every 8 weeks) and will have regular check‑ups and tests.
- Time commitment
- The trial lasts about 54 weeks with scheduled visits for dosing and monitoring throughout the year.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL
- Patients who have never been to exposed to any biologic agent
You likely can't join if
- 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...
- Active tuberculosis. However, the following patients can be included: Patients who were diagnosed with tuberculosis, but were properly treated with...
- Latent tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray...
- HBsAg (Hepatitis B virus surface antigen)-positivity. Patients with negative HBsAg, but positive IgG anti-HBc (Immunoglobulin G anti-Hepatitis B core...
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients who are decided to be not proper to be enrolled into the study by investigators.
The study team makes the final eligibility decision.
Where it is enrolling
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seoul, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.