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New treatment option for Ulcerative Colitis
Official title A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT07012395
What this study is testing
What is SPY001?
SPY001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
Also referred to as SPY001-001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canoga Park, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Colorado Springs, Colorado, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Marrero, Louisiana, United States
- Glen Burnie, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Providence, Rhode Island, United States
- Kingsport, Tennessee, United States
- Cedar Park, Texas, United States
+ 178 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canoga Park, California, United States; La Jolla, California, United States; Lancaster, California, United States; Colorado Springs, Colorado, United States; Kissimmee, Florida, United States; Miami, Florida, United States and 192 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.