Clinical trial 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 drug being studied for the treatment of moderately to severely active ulcerative colitis.
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 study is testing whether long‑acting antibodies given by IV and SC can help control ulcerative colitis and how safe they are.
- Who it's for
- You may be able to join if you are an adult with moderate to severe ulcerative colitis that has not responded well to other medicines.
- What's involved
- You will receive an IV injection at the start of the study and then regular SC injections at home. You will also have clinic visits for check‑ups and blood tests.
- Time commitment
- The study lasts about 6 months, with an initial IV visit followed by monthly SC injections and several clinic visits for monitoring.
- 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 is enrolling
- 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
- St Louis, Missouri, 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
+ 193 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, but 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?
This study is enrolling now at 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 207 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.