The medical network "Dobrobut" has launched its first international clinical trial to evaluate the efficacy of a new drug for Crohn's disease treatment. The investigational drug has been approved by the State Expert Center of the Ministry of Health of Ukraine. The project is led by the network’s chief gastroenterologist, internal medicine specialist Ruslan Buyanovskyi.
As part of this U.S.-manufactured drug’s Phase III clinical trial, patients with Crohn's disease who meet the eligibility criteria will receive free access to innovative treatment. The first two phases of the study confirmed the drug’s safety and efficacy.
"Launching our first international clinical trial is a significant milestone for our network. Only the best clinical sites are selected for such research, and ‘Dobrobut’ has been recognized as one of them. This reflects the highest level of trust among international partners. For our patients, it is an opportunity to receive innovative treatment, and for our doctors, a chance to gain experience in prescribing novel medications and engaging in international collaboration while adhering to the highest standards of Good Clinical Practice. ‘Dobrobut’ doctors are now an integral part of the global team pioneering innovative approaches to treating severe diseases," commented Alexandra Mashkevich, Chief Medical Officer of "Dobrobut".
The "Dobrobut" medical network invites patients with moderate-to-severe Crohn’s disease to participate in the treatment program.
Program Benefits:
- Free access to an innovative drug proven safe and effective in previous research phases;
- Free high-quality laboratory and instrumental diagnostics, with expert gastroenterologists overseeing patients for five years;
- Free transportation to the clinical site.
- The program is open to patients nationwide.
Eligibility Criteria:
- A confirmed Crohn’s disease diagnosis for at least three months before study enrollment.
- Active moderate-to-severe Crohn’s disease (CDAI 220-450).
- Inadequate response, loss of response, or intolerance to one or more of the following treatment categories: local steroids, systemic steroids, immunomodulators, biologic agents, or small-molecule drugs.
Exclusion Criteria:
- Isolated Crohn’s disease in the stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement.
- Presence of complications such as suspected/diagnosed intra-abdominal or perianal abscess, symptomatic strictures or stenosis not passable endoscopically, fulminant colitis, toxic megacolon, or any condition requiring surgery upon study entry.
- Presence of a stoma or need for colostomy/ileostomy.
- History of Crohn’s-related surgery with resection of two or more of the following five segments: terminal ileum, right colon, transverse colon, descending colon, sigmoid, or rectum.
- Short bowel syndrome or uncontrolled chronic diarrhea unrelated to Crohn’s disease.
- History of bowel resection within three months prior to study entry.
- Cancer diagnosis (except fully treated non-melanoma skin cancer or in situ cervical carcinoma after complete surgical removal) within the past five years.
- Infection with HBV, HCV, HIV, or active tuberculosis.
For more information or to schedule a preliminary consultation, call (067)150-29-87.
