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

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study involves people with ulcerative colitis that is moderately to severely active. Ulcerative colitis is a long-term condition where the lining of the large intestine becomes inflamed and develops sores. The study will test several experimental medications that are long-acting antibodies, which are proteins designed to work in the body for an extended period. The medications being tested include SPY001-001 and SPY002, along with additional experimental treatments called SPYPBO-101 and SPYPBO-102. These medications will be given either alone or in combination with each other. Some medications will be given through a needle into a vein, which is called intravenous administration, while others will be given as an injection under the skin, which is called subcutaneous administration. The purpose of this study is to see how well these treatments work and how safe they are for people with this condition.

The study is divided into two parts, called Part A and Part B. In Part A, researchers will look at changes in the tissue of the intestine after 12 weeks of treatment to see if the disease activity has decreased. In Part B, researchers will check if the treatment can help people achieve clinical remission, which means having no or minimal symptoms of the disease, after 12 weeks of treatment. Participants will receive their assigned treatment and have regular check-ups where doctors will examine their condition. This includes procedures where a flexible tube with a camera is used to look inside the intestine, called endoscopy, and taking small tissue samples to examine under a microscope. Some participants may also be taking corticosteroids, which are medications that reduce inflammation, and they may need to continue or gradually reduce these medications during the study.

Throughout the study, doctors will monitor how the medications are working by checking various signs of the disease. They will measure things like changes in disease scores, improvement in the appearance of the intestine lining, and reduction in symptoms. The study will also track the levels of the study medications in the blood and check if the body develops any immune response to these treatments. Part A will last for 12 weeks, while Part B will continue for up to 48 weeks. The study is expected to start enrolling participants in late 2025 and is planned to be completed by early 2028.

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

    Screening and confirmation of eligibility

    Your diagnosis of ulcerative colitis (inflammation of the large intestine causing ulcers) will be confirmed through endoscopy (a procedure using a camera to look inside the intestine) and tissue analysis if this has not been done previously.

    Your disease must have been present for at least 3 months before starting the study.

    The inflammation must extend at least 15 centimeters from the anal opening, confirmed by the screening endoscopy.

    Your disease activity will be assessed using a scoring system that evaluates symptoms such as bowel movements, rectal bleeding, and the appearance of the intestinal lining during endoscopy. Your score must be between 5 and 9 points, with visible bleeding and significant inflammation.

    If you are taking corticosteroids (medications that reduce inflammation) by mouth, the dose must be stable for at least 2 weeks before starting the study. The maximum allowed dose is 20 milligrams per day of prednisone or an equivalent amount of similar medications.

  2. Step 2

    Assignment to Part A or Part B

    You will be assigned to either Part A or Part B of the study. Both parts last 12 weeks initially, but Part B may continue up to 48 weeks.

    The assignment will determine the specific treatment approach and assessment methods used during the study.

  3. Step 3

    Treatment period from Day 1 to Week 12

    You will receive one or more of the study medications. The medications used in this study are SPY001-001 and SPY002, which are long-acting antibodies designed to reduce inflammation in ulcerative colitis.

    These medications can be given in two ways: subcutaneously (injection under the skin) or intravenously (infusion into a vein).

    The specific medication, dosage, frequency, and method of administration will be determined by the study protocol for your assigned group.

    If you are in Part A and taking corticosteroids, you will maintain the same dose throughout the 12-week treatment period.

    If you are in Part B and taking corticosteroids, you will maintain the same dose through Week 6, then begin gradually reducing the dose starting at Week 6.

  4. Step 4

    Assessments at Week 12

    At Week 12, your condition will be evaluated to measure the effectiveness of the treatment.

    If you are in Part A, the main assessment will focus on changes in histologic disease activity (examination of tissue samples under a microscope to assess inflammation) compared to the beginning of the study.

    If you are in Part B, the main assessment will determine whether you have achieved clinical remission (absence or minimal symptoms of the disease).

    Additional assessments will include evaluation of intestinal lining appearance through endoscopy, symptom scores, and blood tests to measure drug levels and immune responses to the study medications.

  5. Step 5

    Extended treatment period for Part B participants

    If you are in Part B, the study may continue beyond Week 12 up to Week 48.

    During this extended period, additional assessments will be conducted to evaluate long-term effectiveness, including clinical remission status at Week 48.

    Continued monitoring of drug levels and immune responses will occur throughout this period.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You must have been diagnosed with ulcerative colitis (a condition causing inflammation and sores in the lining of the large intestine) for at least 3 months before starting the study, confirmed by a procedure where a camera examines your intestine and tissue samples
  • Your ulcerative colitis must be active and affect an area of at least 15 centimeters from the anal opening, confirmed by the screening examination with a camera
  • Your disease must be moderately to severely active, measured by specific scores that assess your symptoms including bleeding and inflammation seen during examination
  • You must have a history of one of the following: being dependent on corticosteroids (medicines that reduce inflammation), not responding well to treatment, losing response to treatment over time, or not being able to tolerate at least one type of treatment, which includes either standard treatments like corticosteroids or immune-suppressing medicines, or advanced therapies like specific biological medicines or other specialized drugs
  • If you are taking oral corticosteroids (anti-inflammatory pills), you must have been on a stable dose for at least 2 weeks before starting the study and be willing to continue the same dose during the study period as specified for your group

Who cannot join the trial?

4 criteria

  • The study has not provided specific exclusion criteria information in the available data
  • You should discuss with the study doctor whether you are eligible to participate based on your individual health situation
  • General exclusion criteria typically exist for clinical trials but are not listed in the provided study information
  • The study doctor will review your complete medical history to determine if you can safely participate
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Investigated drugs

  • Long-acting antibodies

    are medications designed to stay in your body for an extended period of time. These are special proteins that work by targeting specific parts of your immune system that may be causing inflammation in your intestines. In this trial, they are being tested alone or in different combinations to see if they can help reduce the symptoms and inflammation caused by ulcerative colitis.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in clinical trials to compare against the actual medications being tested to help determine if the medications are truly effective.

What is already known about the treatment

Long-acting Antibodies – Long-acting antibodies are a type of medication given through injection or infusion that stays in the body for an extended period of time to help treat inflammatory bowel diseases. These medications are currently being studied in clinical trials to determine their effectiveness and safety for treating moderately to severely active ulcerative colitis, a condition where the colon becomes inflamed and develops sores. The antibodies work by targeting specific proteins in the body that cause inflammation, helping to reduce the immune system's attack on the intestinal lining. This treatment is being tested both alone and in combination with other medications to see if it can reduce disease activity in the colon tissue and help patients achieve remission, which means their symptoms are under control.

Investigated diseases

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory bowel disease that affects the lining of the large intestine and rectum. The condition causes long-lasting inflammation and sores called ulcers in the innermost lining of the colon. Symptoms typically include abdominal pain, diarrhea often with blood or pus, and urgent bowel movements. The disease usually develops gradually and can worsen over time if not managed properly. People with this condition often experience periods when symptoms flare up and other times when symptoms improve or disappear. The inflammation typically starts in the rectum and can spread continuously through the colon.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521242-26-00Protocol codeSPY123-201Estimated enrolment650 patientsSponsorSpyre Therapeutics Inc.

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