NCT07012395 · Spyre Therapeutics, Inc.
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
(SKYLINE-UC)
What this study is about
This is a Phase 2, conducted at multiple hospitals, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the effectiveness and safety of multiple interventions following given through a vein (IV) (IV) induction and injected under the skin (SC) maintenance treatment.
View original scientific description
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Interventions
DRUG
SPY001
Experimental
DRUG
SPY002
Experimental
DRUG
SPY003
Experimental
OTHER
Placebo
Placebo
Primary outcome measures
Part A: Change in Robarts Histopathology Index (RHI)
Time frame: Week 12
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Part B: Percentage of participants with clinical remission
Time frame: Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
- Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)
- Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2
Exclusion criteria
- Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
- Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
- Failed 4 or more approved or investigational advanced therapy classes
Where
- Canoga Park, California
- La Jolla, California
- Lancaster, California
- Colorado Springs, Colorado
- Kissimmee, Florida
- Miami, Florida
- Chicago, Illinois
- Kansas City, Kansas
- Louisville, Kentucky
- Marrero, Louisiana
- Glen Burnie, Maryland
- Boston, Massachusetts
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations