The study involves people with Ulcerative colitis, a type of Inflammatory Bowel Disease that causes inflammation and sores in the lining of the colon, leading to symptoms such as frequent diarrhea, abdominal pain, and bleeding. The investigational products are long‑acting antibodies designed to target the immune system. The antibodies are given as a subcutaneous injection, which means the medication is placed just under the skin. The trial includes three test antibodies identified as SPY001-001, SPY003 and SPY002, as well as a control injection called SPYPBO-101.
The purpose of the study is to assess the safety and tolerability of the study drug treatment regimens. Participants will receive one of the injections on a regular schedule and will be followed for several months, during which they will attend clinic visits to report any side effects and to undergo routine examinations, including an endoscopic assessment, which uses a small camera to view the inside of the colon and determine whether the disease has improved. The study tracks any new health problems that arise and looks for signs of improvement in the colon lining.
1enrollment and baseline assessment
after joining the study, the patient completes a set of baseline examinations that document the current condition of ulcerative colitis. these examinations include medical history, laboratory tests, and an endoscopic view of the intestine.
the collected information serves as a reference point for later comparisons.
2randomization to treatment group
the patient is assigned by the study system to receive either spypbo-101 (placebo) or one of the test antibodies (spy001-001, spy002, spy003).
the assignment is made without the patient knowing which product is being given.
3first subcutaneous injection
the patient receives the first injection under the skin (subcutaneous route) using a solution for injection.
each product is labeled with a dose of 0 mg/ml, which reflects the study‑specified concentration. the injection is performed by qualified study staff.
4scheduled follow‑up visits and additional injections
the patient returns to the study site at predefined intervals (for example, weeks 4, 12, 24, and 48).
at each visit, a new subcutaneous injection of the same product is given according to the study schedule.
the patient also undergoes safety checks, laboratory tests, and symptom questionnaires at each visit.
5monitoring for safety and efficacy
throughout the trial, the patient reports any new symptoms or side effects (treatment‑emergent adverse events).
the study team records these reports and evaluates whether the medication is tolerated.
6final evaluation at week 48
at the end of week 48, the patient undergoes a final endoscopic examination to assess improvement of ulcerative colitis.
the results are compared with the baseline data to determine the effect of the assigned product.
Who Can Join the Study?
Be a patient with ulcerative colitis, the condition being studied.
Be either male or female; both sexes are allowed to join.
Be within the age groups defined by the trial (the study’s age range codes 3 and 4).
Meet one of the following three options:
Have finished Part A of the earlier study and the doctor (called the investigator) believes you are receiving clinical benefit – meaning the treatment is helping your disease.
Have finished Part B of the earlier study.
Have taken part in Part B and met the study’s escape criteria, which means either:
You did not get enough improvement during the induction treatment period (ITP) – the early phase when the medication is first given, or
Your disease got worse during the maintenance treatment period (MTP) – the later phase when the medication is continued to keep the disease under control.
Who Cannot Join the Study?
If you have already met any reason that would stop treatment in a related previous study, you cannot join this trial. (treatment discontinuation criteria are the reasons that would end participation in a study.)
If you are currently taking any medicines that suppress the immune system, such as azathioprine, 6‑MP, methotrexate, tacrolimus, cyclosporine, mycophenolate mofetil, penicillamine, leflunomide, thalidomide, or similar drugs, if you are using any advanced biologic or small‑molecule therapy, if you are using any experimental drug other than the study drug, or if you receive nutrition directly into a vein (total parenteral nutrition), you cannot join.
If you develop any new or uncontrolled serious health problem affecting major body systems—such as the liver (hepatic), kidneys (renal), blood (hematological), heart (cardiovascular), lungs (pulmonary), brain or nerves (neurological), skin (dermatological), digestion (gastrointestinal), hormones (endocrine), mental health (psychiatric), or if you have an infection, a weakened immune system, or cancer— you cannot join. This also includes laboratory results that show: liver enzymes ALT or AST more than three times the normal upper limit, a total white blood cell count less than 1,000 per microliter, an absolute neutrophil count less than 500 per microliter, or an abnormal heart rhythm test called a prolonged QTcF interval (≥450 ms for men or ≥470 ms for women).
If you have an active infection that requires oral or intravenous antimicrobial (antibiotic) treatment on the first day of the study, you cannot join.
SPY001-001 is a laboratory‑made antibody that is given under the skin. In this study it is being tested on its own to see if it can safely reduce the inflammation that causes symptoms of inflammatory bowel disease. Researchers are watching participants closely to learn how well the antibody works and whether it causes any side effects.
SPY002 is another experimental antibody delivered by a subcutaneous injection. The trial is evaluating this medication both as a single treatment and together with other antibodies to find out if it can improve the safety and effectiveness of therapy for people with inflammatory bowel disease. Participants will be monitored for any adverse reactions and for changes in their disease activity.
SPY003 is a third investigational antibody administered under the skin. It is being studied in the same way as the other two drugs, looking at how safe it is and whether it helps control the inflammation of inflammatory bowel disease when used alone or in combination with the other study drugs. The study will track participants for any side effects and for improvements in their condition.
Ulcerative colitis – Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. It usually begins with mild irritation and may develop into more extensive swelling of the colon. Over time, the inflamed tissue can produce frequent urges to have a bowel movement and may result in bleeding. The disease often follows periods of increased activity with more symptoms, followed by times when symptoms lessen. The pattern of flare‑ups and calmer periods can vary from person to person.
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