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SPY002

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.

Table of Contents

Trial overview

The available trial of SPY002 is a Phase 2 study in moderately to severely active ulcerative colitis.[1] It is an interventional study, which means researchers assign study treatments and then measure the results.[1] The study status is Authorised and the planned enrollment is 645 people.[1]

Who is being studied

The target population is people with moderately to severely active ulcerative colitis.[1] 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.[1] The source does not provide more detailed joining rules, such as age limits or other eligibility requirements.[1]

What the trials measure

The main results, called primary outcomes, are measured at Week 12.[1] 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.[1] 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.[1]

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.[1] The source also lists different study products, including SPYPBO-102, SPYPBO-101, and SPY001-001, along with SPY002.[1] SPY002 is listed with subcutaneous administration, meaning given under the skin, and intravenous administration, meaning given through a vein.[1]

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.[1] The planned enrollment is 645, which means up to 645 participants are expected to be included.[1] The study is large enough to give a more detailed look at how SPY002 may perform in this patient group.[1]

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.[1] 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.[1] The source does not provide information about study visits, randomization, or detailed participation steps, so those details cannot be added here.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07012395 Phase 2 Moderately to Severely Active Ulcerative Colitis Authorised 645

FAQ

  • What is being studied in SPY002 clinical trials? The trial is studying SPY002 as part of a treatment program for moderately to severely active ulcerative colitis. It is looking at whether the treatment can improve disease activity and help people reach remission.
  • Who may take part in the SPY002 trial? People with moderately to severely active ulcerative colitis are the target group. The trial data do not give more detailed joining rules in the source provided.
  • What phase is the SPY002 trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to collect safety information.
  • What results are the researchers measuring? The main results are change in RHI at Week 12 and clinical remission at Week 12. RHI means Robarts Histopathology Index, a score used to measure inflammation in tissue samples.
  • Is SPY002 being studied alone or with other treatments? The trial includes SPY002 alone and in combination with other long-acting antibodies. It also includes different ways of giving the study drug, such as subcutaneous and intravenous administration.

Ongoing Clinical Trials on SPY002

  • A Study of Long-acting Antibodies SPY001-001 and SPY002 Alone and Combined for Adults with Moderate to Severe Ulcerative Colitis

    Recruiting

    1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia France +10

Glossary

  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the large intestine, also called the colon.
  • Moderately to severely active: This means the disease is not mild. Symptoms and inflammation are strong enough that researchers classify the condition as moderate or severe.
  • Phase 2: A middle stage of clinical research that checks whether a treatment may work and continues to watch for safety.
  • Interventional study: A trial where researchers assign a treatment or procedure and then measure the results.
  • Clinical remission: A period when signs and symptoms of the disease become very low or disappear.
  • Histologic disease activity: Inflammation seen under a microscope in tissue samples from the bowel.
  • RHI: Short for Robarts Histopathology Index, a scoring system used to measure how active inflammation is in tissue.
  • Baseline: The starting point before treatment begins.
  • Week 12: The time point 12 weeks after treatment starts, used to check results.
  • Subcutaneous: Given under the skin.
  • Intravenous: Given through a vein.

References