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Long‑Term Safety and Efficacy of SPY001-001, SPY002 and SPY003 in Adults with Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Ulcerative colitis is a form of Inflammatory Bowel Disease that causes long‑lasting inflammation of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and bleeding. The trial will evaluate several experimental long‑acting antibodies—identified by the code names SPY001-001, SPY003, and SPY002—which are given as a solution for injection under the skin. A matching inactive substance, called SPYPBO-101, will be used as a control.

The purpose of the study is to assess the safety and tolerability of these treatment regimens. Participants will receive a single injection at the start and then continue receiving additional injections according to a fixed schedule over many months. Regular visits will be scheduled to check health status, and an examination of the intestine using a camera (often called an endoscopy) will be performed around week 48 to see how the lining has responded.

Throughout the trial, researchers will closely watch for any side effects that arise after treatment and will record any new health problems. The endoscopic examination will help determine whether the inner surface of the colon shows signs of healing, providing an indication of how well the medication may be working while ensuring participants remain safe.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    After joining the study, a baseline visit is scheduled to collect health information and confirm eligibility for ulcerative colitis.

    During this visit, participants are assigned to receive either the placebo (spypbo-101) or one of the test medications (spy001-001, spy002, spy003) alone or in combination.

  2. Step 2

    First medication administration

    The assigned medication is given as a subcutaneous injection, which means the drug is injected just under the skin.

    Each injection contains a solution for injection with a concentration of 0 mg/ml, as specified for the study drug.

    The injection is administered according to the study schedule; the exact frequency is defined by the protocol and occurs at each scheduled visit.

  3. Step 3

    Regular follow‑up visits

    Participants attend follow‑up visits at regular intervals to monitor safety and tolerability.

    At each visit, a new subcutaneous injection is given according to the assigned regimen.

    The study team records any treatment‑emergent adverse events (new side effects that appear after starting the medication) and conducts routine laboratory tests.

  4. Step 4

    Endoscopic assessment at week 48

    At week 48, a colonoscopy is performed to evaluate the condition of the colon and determine endoscopic improvement.

    The results contribute to the secondary objective of the study.

  5. Step 5

    Continued treatment and final assessment

    After week 48, participants continue receiving the assigned subcutaneous injections as scheduled until the study reaches its end date.

    The final visit includes a comprehensive safety evaluation, collection of all remaining data, and a summary of the long‑term safety and efficacy outcomes.

Who can join the trial?

5 criteria

  • Have a diagnosis of ulcerative colitis (a type of inflammatory bowel disease).
  • Be 18 years of age or older and can be male or female.
  • Have completed Part A of the earlier study and be judged by the investigator to be receiving clinical benefit (meaning the treatment appears to be helping you).
  • Have completed Part B of the earlier study.
  • Have taken part in Part B and met the study’s escape criteria (meaning the treatment did not give enough improvement during the induction treatment period or the disease got worse during the maintenance treatment period).

Who cannot join the trial?

11 criteria

  • You have already met any reason that would stop treatment in the earlier study SPY123-201, such as criteria that require you to leave that study.
  • You are taking medicines that are not allowed for this trial, including:
    • Immunosuppressants – drugs that lower the activity of your immune system (examples: azathioprine, 6‑MP, methotrexate).
    • Strong immune‑suppressing drugs such as tacrolimus, cyclosporine, oral mycophenolate mofetil, leflunomide, thalidomide, or similar agents.
    • Any marketed advanced therapy – biologic drugs or small‑molecule medicines that target the immune system.
    • Any other experimental (investigational) drug besides the study drug.
    • Total parenteral nutrition – nutrition given directly into a vein.
    • You have a new, unstable, or uncontrolled health problem in any major body system (such as metabolism, skin, liver, kidneys, blood, lungs, heart, digestive tract, nerves, breathing, hormones, or mental health), or you have an infection, a weakened immune system, or cancer that your doctor believes could make participation unsafe or affect the study results. This also includes laboratory or heart test results that are far outside normal, such as:
      • Liver enzymes called ALT or AST that are more than three times the upper limit of normal.
      • A very low total white blood cell count (WBC less than 1,000 cells per microliter).
      • A very low absolute neutrophil count (ANC less than 500 cells per microliter).
      • An abnormal heart rhythm test (ECG) showing a prolonged QTc interval (≥450 ms for men or ≥470 ms for women).
      • You have an ongoing infection that requires you to take oral or intravenous (through a vein) antimicrobial therapy on the first day of the study.
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Investigated drugs

  • SPY001-001

    is an experimental long‑acting antibody that is being tested as a single treatment or in combination with other study drugs. It is given as a solution that is injected under the skin. The goal is to see if it can safely reduce inflammation in people with inflammatory bowel disease over a long period.

  • SPY002

    is another experimental long‑acting antibody studied in the same trial. Like the others, it is administered as a subcutaneous injection in a liquid form. Researchers are evaluating whether it can safely improve symptoms and control inflammation in participants with inflammatory bowel disease when used alone or with other agents.

  • SPY003

    is the third investigational long‑acting antibody included in this study. It is also given as a solution for injection under the skin. The trial will assess its long‑term safety and effectiveness in helping to manage inflammatory bowel disease, either by itself or together with the other study medications.

What is already known about the treatment

  • SPY001-001

    This drug is given as a subcutaneous injection of a clear solution. It is an investigational monoclonal antibody that is still being studied in clinical trials. The medication is being tested for ulcerative colitis, a type of inflammatory bowel disease. It works by attaching to a specific protein that causes inflammation, helping to lower the body’s inflammatory response.

  • SPY002

    This medication is administered by a subcutaneous injection of a sterile solution. It is a research‑stage antibody that has not yet been approved for regular medical use. The drug is aimed at treating ulcerative colitis, an inflammatory condition of the colon. It reduces disease activity by binding to an inflammation‑triggering molecule and blocking its effect.

  • SPY003

    This product is delivered as a subcutaneous injection of a liquid solution. It is a novel antibody currently in experimental trials and not yet available on the market. The intended use is for ulcerative colitis, part of inflammatory bowel disease. Its action involves targeting a key inflammatory signal, thereby calming the immune system’s over‑reaction.

Investigated diseases

Ulcerative colitis - A chronic condition that causes inflammation and ulcer formation in the inner lining of the colon. It typically begins with mild diarrhea and may progress to frequent loose stools, abdominal cramps, and an urgent need to go to the bathroom. As the inflammation spreads, blood may appear in the stool and the lining can become more damaged. The disease often follows a pattern of flare‑ups, when symptoms worsen, and periods of relative calm. Over time, repeated inflammation can lead to thicker stool and increased fatigue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524640-35-00Protocol codeSPY123-202Estimated enrolment645 patientsSponsorSpyre Therapeutics Inc.

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