In short
Clinical trials are investigating SPY002 in people with moderately to severely active ulcerative colitis. These studies aim to assess how well the treatment works and how safe it is, with outcomes such as tissue healing and clinical remission. The trial shown here is in adults with active disease.
Key points
- Clinical trials are investigating SPY002 in people with moderately to severely active ulcerative colitis. The trial shown is a Phase 2 interventional study with 645 planned participants. Researchers are looking at whether the treatment can improve tissue inflammation and help people reach clinical remission after 12 weeks. The study includes SPY002 alone and in combinations with other long-acting antibodies. It also uses both subcutaneous and intravenous administration in different study parts.
Trial overview
The available trial of SPY002 is a Phase 2 study in moderately to severely active ulcerative colitis. It is an interventional study, which means researchers assign study treatments and then measure the results. The study status is Authorised and the planned enrollment is 645 people.
Who is being studied
The target population is people with moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term disease that causes inflammation in the large intestine, and “active” means the disease is currently causing symptoms and inflammation. The source does not provide more detailed joining rules, such as age limits or other eligibility requirements.
What the trials measure
The main results, called primary outcomes, are measured at Week 12. In Part A, the study looks at the change in RHI from baseline, which is a score used to measure tissue inflammation under the microscope. In Part B, the study measures clinical remission at Week 12, meaning whether signs and symptoms of the disease improve enough to be considered in remission.
Study design and treatment groups
The trial includes SPY002 in more than one study setting, including use alone and in combinations with other long-acting antibodies. The source also lists different study products, including SPYPBO-102, SPYPBO-101, and SPY001-001, along with SPY002. SPY002 is listed with subcutaneous administration, meaning given under the skin, and intravenous administration, meaning given through a vein.
Trial phase and size
This study is in Phase 2, a stage of research that usually focuses on whether a treatment may work while continuing to collect safety information. The planned enrollment is 645, which means up to 645 participants are expected to be included. The study is large enough to give a more detailed look at how SPY002 may perform in this patient group.
What participants should know
Based on the trial data, the main focus is on whether SPY002 can improve bowel inflammation and help people reach remission after 12 weeks. The study uses tissue-based measurement in one part and symptom-based remission in another part, so it looks at both microscopic healing and clinical response. The source does not provide information about study visits, randomization, or detailed participation steps, so those details cannot be added here.