BCD-261-2/COMANDOR “A randomized, double-blind, placebo-controlled study of the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-261 in subjects with active moderate to severe Crohn's disease”.
Over the course of the BCD-261-2/COMANDOR clinical trial, the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-261 will be studied in subjects with active moderate to severe Crohn's disease who:
Are 18–75 years of age inclusive at the time of signing the informed consent form.
Have a documented diagnosis of Crohn's disease with involvement of the terminal ileum or colon (Montreal classification types L1-L3) that was established 3 months or more before signing the informed consent form and confirmed by endoscopic findings.
Have active moderate to severe Crohn's disease that manifests by the following signs:
Crohn's disease activity index (CDAI)1 ≥ 220 and ≤ 450.
Simple Endoscopic Score for Crohn's Disease (SES-CD)2 ≥6 points or ≥4 points for the disease form with isolated ileum lesions (per central independent re-evaluation).
Have an inadequate response (persistence of disease activity, steroid dependence, primary lack of response to therapy, or loss of response to therapy) to prior treatment with glucocorticoids, immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate) or biologics (anti-TNFα and/or anti-integrins, and/or IL-12/23 inhibitors), targeted immunosuppressors (upadacitinib).
Maintain a stable dose of concomitant products: for 2 weeks or more before signing the informed consent form and during the screening period3 for glucocorticoids, and for 4 weeks or more before signing the informed consent form and during the screening period for immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate).
The clinical trial protocol specifies that ileocolonoscopy is to be performed as part of the study.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Clinical Investigator. In particular, the non-inclusion criteria are:
Presence of ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated diverticular disease at the time of signing the informed consent form or in the medical history.
History of primary sclerosing cholangitis.
Presence of an active intra-abdominal or perianal abscess at the time of signing the informed consent form.
Presence of an intestinal stricture/stenosis obstructing endoscopy at the time of signing the informed consent form.
Prior small bowel resections with total resected length > 100 cm and/or resection of > 2 segments of the colon (ascending colon, including cecum; transverse colon; descending colon, including sigmoid; rectum)4.
Presence of or need for an intestinal stoma or artificial rectum.
Presence of acute infections or activation of chronic infections within 4 weeks before signing the informed consent form and during the screening period, including an increase in body temperature to ≥38°C at the randomization visit, that is not associated with the underlying disease.
Vaccination with live vaccines at any time within 12 weeks before signing the informed consent form or the expected need for such vaccination during the trial.
Lack of efficacy of 3 or more classes (by INN) of biologics/targeted immunosuppressors with different mechanisms of action (anti-TNFα, anti-integrins, IL-12/23 inhibitors, upadacitinib) or 4 or more (by INN) biologics/targeted immunosuppressors regardless of their mechanism of action.
Surgical interventions performed less than 90 days prior to signing the informed consent form or planned major surgical interventions for the study period.
The BCD-261-2/COMANDOR clinical trial is being conducted in study centers in various cities of the Russian Federation, including Moscow, St. Petersburg, Kazan, Barnaul, Novosibirsk, Chelyabinsk, Ufa, Krasnoyarsk, Rostov-on-Don, Vladivostok, and Ulyanovsk.
To ask questions about potential participation in a clinical trial, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications to participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and/or their attending physician.
Clinical Study Authorization No. 247 dated June 6, 2025 of the Ministry of Health of the Russian Federation and the list of authorized study centers are published in the State Register of Medicines.
CDAI, Crohn's Disease Activity Index.
SES-CD, Simple Endoscopic Score for Crohn's Disease.
Screening is a specific time period aimed at assessing a subject’s eligibility in a clinical trial according to the inclusion/non-inclusion criteria based on the diagnostic procedures and medical specialist consultations.
The criterion admits subjects in whom the volume of previous resection is limited to ileocecal resection or right hemicolectomy.