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Tests treatment safety and results for Crohn's Disease (CD)
Official title Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
ClinicalTrials.gov ID: NCT07078994
What this study is testing
What is anti-TL1A monoclonal antibody, low dose?
anti-TL1A monoclonal antibody, low dose is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for crohn's disease (cd).
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 aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients with moderate to severe active Crohn's Disease. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active Crohn's Disease and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics/targeted immunosuppressants.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 75
You may be able to join if
- The diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3 according to the Montreal classification), established ≥3 months...
- Moderate to severe active Crohn's disease, manifested by the following signs: (1) Crohn's Disease Activity Index (CDAI) ≥220 and ≤450 points. (2)...
- Persistent symptoms of disease activity despite treatment with at least one course of glucocorticoids including prednisolone at a dose of ≥40 mg/day...
- Steroid dependence manifested by an increase in disease activity after initial improvement, with a decrease in the dose of glucocorticoids below the...
- Persistent symptoms of disease activity despite treatment with at least one course of immunosuppressants (azathioprine at a dose of ≥2.0 mg/kg and/or...
You likely can't join if
- A history of or current at the time of signing the ICF ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic...
- A history of primary sclerosing cholangitis.
- Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.
- Presence of an endoscopically obstructed stricture/stenosis of the intestine at the time of signing the ICF.
- A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
- A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.
See the full eligibility criteria
- The diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3 according to the Montreal classification), established ≥3 months prior to signing the informed consent form and confirmed by endoscopic...
- Moderate to severe active Crohn's disease, manifested by the following signs: (1) Crohn's Disease Activity Index (CDAI) ≥220 and ≤450 points. (2) Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 points or ≥4...
- Persistent symptoms of disease activity despite treatment with at least one course of glucocorticoids including prednisolone at a dose of ≥40 mg/day or equivalent or budesonide ≥9 mg/day or equivalent for at least 2...
- Steroid dependence manifested by an increase in disease activity after initial improvement, with a decrease in the dose of glucocorticoids below the dose equivalent to 10 mg of oral prednisolone per day, within 3 months...
- Persistent symptoms of disease activity despite treatment with at least one course of immunosuppressants (azathioprine at a dose of ≥2.0 mg/kg and/or 6-mercaptopurine at a dose of ≥1.0 mg/kg and/or methotrexate at a...
- Primary lack of response to therapy with TNFa inhibitors and/or anti-integrins, and/or IL-12/23 inhibitors, and/or targeted immunosuppressors (upadacitinib), defined as the persistence of symptoms of disease activity...
- Loss of response to therapy with TNFa inhibitors and/or anti-integrins, and/or IL-12/23 inhibitors, and/or targeted immunosuppressors (upadacitinib), defined as the appearance of symptoms of disease activity after...
- A history of intolerance to glucocorticoid therapy and/or immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate) and/or biologic therapies (TNFα inhibitors, anti-integrins, IL-12/23 inhibitors) and/or targeted...
- A history of or current at the time of signing the ICF ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.
- A history of primary sclerosing cholangitis.
- Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.
- Presence of an endoscopically obstructed stricture/stenosis of the intestine at the time of signing the ICF.
- A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
- A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.
- Previous resections of the small intestine with a total length of resected segments \>100 cm and/or resection of \>2 segments of the large intestine (ascending colon (including the cecum), transverse colon, descending...
- Presence of intestinal stoma or artificial rectum or the need for them.
- Failure of ≥3 classes of biologics/targeted immunosuppressors (according to INN) with different mechanisms of action (TNFa inhibitors, anti-integrins, IL-12/23 inhibitors, upadacitinib) or ≥4 biologics/targeted...
- Use of any of the indicated therapies within the specified time frame or need for therapy with these drugs during the study period:
- Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
- Use of anti-integrins or IL-12/23 inhibitors within 12 weeks before signing the ICF or during the screening period.
- Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to signing the ICF or during the screening period.
- Use of oral glucocorticoids at a dose equivalent to prednisone \>20 mg/day or budesonide \>9 mg/day or rectal administration of glucocorticoids at any dose within 2 weeks prior to signing the ICF or during the screening...
- Use of immunosuppressants not included in the approved therapy (tacrolimus, cyclosporine, mycophenolate mofetil, rapamycin, leflunomide, penicillamine, etc.) within 4 weeks before signing the ICF or during the screening...
- Long-term regular use of non-steroidal anti-inflammatory drugs (≥3 times a week for ≥6 weeks) for 2 weeks prior to signing the ICF.
- Use of any other investigational drugs in other clinical trials at the time of signing the ICF or less than 8 weeks or 5 half-lives (whichever is longer) before the date of signing the ICF or during screening.
The study team makes the final eligibility decision.
Where it's taking place
- Barnaul, Altayskiy Kray, Russia
- Ufa, Bashkortostan Republic, Russia
- Moscow, Moscow, Russia
- Novosibirsk, Novosibirsk Oblast, Russia
- Rostov-on-Don, Rostov Oblast, Russia
- Saint Petersburg, Sankt-Peterburg, Russia
- Kazan', Tatarstan Republic, Russia
- Chelyabinsk, Russia
- Krasnoyarsk, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Ulyanovsk, Russia
- Vladivostok, Russia
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 - 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barnaul, Altayskiy Kray, Russia; Ufa, Bashkortostan Republic, Russia; Moscow, Moscow, Russia; Novosibirsk, Novosibirsk Oblast, Russia; Rostov-on-Don, Rostov Oblast, Russia; Saint Petersburg, Sankt-Peterburg, Russia and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.