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Enrolling by invitationPhase 2

Long-term study of long-acting antibodies alone and combined for ulcerative colitis

Tests long-acting antibodies SPY001, SPY002 and SPY003 in adults with ulcerative colitis.

Key facts

Who runs it
Spyre Therapeutics, Inc.
Where
Belgrade and Zrenjanin, SerbiaSee the 4 sitesAlso in 28 other countries, 172 sites
Trial code
Registry title
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Status
Enrolling by invitation
Phase
Phase 2
People taking part
645 people, planned
Started
8 Jun 2026
Expected to end
3 Jan 2030
Type of study
Interventional, 10 groups
Treatments tested
  • SPY001
  • SPY002
  • SPY003
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ulcerative colitis who took part in the earlier study SPY123-201 and either finished it or left it because the treatment did not work well enough.

Age
18 years or older
Sex
All sexes can join
Disease stage
Ulcerative colitis; must have completed Part A (and be judged by the investigator to be benefiting), completed Part B, or met the escape criteria in Part B of study SPY123-201
Earlier treatment
Must have taken part in study SPY123-201. Must not be taking immunosuppressants, any marketed advanced therapy (biologic or small molecule), any other investigational therapy, or total parenteral nutrition.

Main reasons for not taking part

  • Met any treatment stop criteria in study SPY123-201
  • Taking a prohibited medication, such as immunosuppressants or other advanced therapies
  • New, unstable or uncontrolled illness or suspected immune deficiency or cancer that the investigator thinks raises the risk
  • Ongoing infection needing antibiotics or other antimicrobial treatment on Day 1

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Participants must meet 1 of the following criteria from Study SPY123-201:
  • Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
  • Completed Part B
  • Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period [ITP] or experienced disease worsening during the maintenance treatment period [MTP])

Who cannot take part

  • Is on any of the following prohibited medications:; Immunosuppressants (eg, azathioprine, 6-mercaptopurine [6-MP], or methotrexate); Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects; Any marketed advanced therapy (ie, biologic or small molecule); Any investigational therapy other than SPY123-201 study drug; Total parenteral nutrition
  • Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance
  • Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1
  • Met any treatment discontinuation criteria from Study SPY123-201

Where in Serbia

Also in 28 other countries, 172 sites

  • BelgradeHospital not named in the registryNo longer taking part
  • BelgradeHospital not named in the registryNo longer taking part
  • BelgradeHospital not named in the registryNo longer taking part
  • ZrenjaninHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

The 10 groups in the trial

  • SPY001 Dosing Regimen 1Treatment being tested

    Participants will receive SPY001

    Treatment: SPY001

  • SPY002 Dosing Regimen 1Treatment being tested

    Participants will receive SPY002

    Treatment: SPY002

  • SPY003 Dosing Regimen 1Treatment being tested

    Participants will receive SPY003

    Treatment: SPY003

  • SPY001 Dosing Regimen 2Treatment being tested

    Participants will receive SPY001

    Treatment: SPY001

  • SPY002 Dosing Regimen 2Treatment being tested

    Participants will receive SPY002

    Treatment: SPY002

  • SPY003 Dosing Regimen 2Treatment being tested

    Participants will receive SPY003

    Treatment: SPY003

  • SPY001 & SPY002Treatment being tested

    Participants will receive SPY001 and SPY002

    Treatment: SPY001 and SPY002

  • SPY001 & SPY003Treatment being tested

    Participants will receive SPY001 and SPY003

    Treatment: SPY001 and SPY003

  • SPY002 & SPY003Treatment being tested

    Participants will receive SPY002 and SPY003

    Treatment: SPY002 and SPY003

  • SPY002 Dosing Regimen 3Treatment being tested

    Participants will receive SPY002

    Treatment: SPY002

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel Disease
Plain-language title
Long-term study of long-acting antibodies alone and combined for ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 10 November 2026.
Record updated
9 November 2026