BCD-261-4/ULTRAMARINE “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 ulcerative colitis”.
Over the course of the BCD-261-4/ULTRAMARINE clinical trial, the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-261 will be studied in subjects with active ulcerative colitis who:
Are 18–75 years of age inclusive at the time of signing the informed consent form.
Have a documented diagnosis of ulcerative colitis with involvement of the colon proximal to the rectum (15 cm or more from the distal edge of the anal canal) that was established 3 months or more before signing the informed consent form and confirmed by endoscopic findings.
Have moderate to severe active ulcerative colitis with a modified Mayo score (mMS)1 of not less than 4 and not more than 9, with an endoscopic component score of 2 or more (by central independent re-evaluation) and a rectal bleeding score of 1 or more.
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) or biologics (anti-TNFα and/or anti-integrins, and/or IL-12/23 inhibitors), targeted immunosuppressors (Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators).
Maintain a stable dose of concomitant products for 2 or more weeks prior to signing the informed consent form and during the screening period2 for glucocorticoids and 5-ASA products3 and for 4 or more weeks prior to signing the informed consent form and during the screening period for immunosuppressors (azathioprine, 6-mercaptopurine).
The clinical study protocol specifies that a colonoscopy with biopsy of the most affected area of the colon 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 Crohn's disease, 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.
History of fulminant colitis, toxic dilatation of the colon, intestinal obstruction, intestinal perforation (other than caused by trauma or appendicitis).
Presence of or need for an intestinal stoma or artificial rectum at the time of signing the informed consent form.
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, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators) 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. 246 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.
mMs, Modified Mayo score.
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.
5-ASA (5-aminosalicylic acid) is an anti-inflammatory finished product that is used primarily in the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease.