A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Recruiting · NCT07012395 · Interventional (participants receive a specific treatment) · Lead sponsor: Spyre Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSPY001SPY002SPY003
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
60 locations listed across 16 US states.
- Site 024 - Canoga Park, California, United States
- Site 023 - La Jolla, California, United States
- Site 012 - Lancaster, California, United States
- Site 033 - Colorado Springs, Colorado, United States
- Site 007 - Kissimmee, Florida, United States
- 029 - Miami, Florida, United States
- Site 038 - Chicago, Illinois, United States
- Site 006 - Kansas City, Kansas, United States
- Site 030 - Louisville, Kentucky, United States
- Site 035 - Marrero, Louisiana, United States
- Site 011 - Glen Burnie, Maryland, United States
- Site 003 - Boston, Massachusetts, United States
- Site 028 - Rochester, Minnesota, United States
- Site 037 - New York, New York, United States
- 040 - Chapel Hill, North Carolina, United States
- Site 041 - Durham, North Carolina, United States
- Site 016 - Winston-Salem, North Carolina, United States
- Site 025 - Providence, Rhode Island, United States
- Site 017 - Kingsport, Tennessee, United States
- Site 013 - Cedar Park, Texas, United States
- Site 005 - Garland, Texas, United States
- Site 002 - San Antonio, Texas, United States
- Site 008 - Southlake, Texas, United States
- Site 009 - Webster, Texas, United States
- Site 004 - Seattle, Washington, United States
- Site 019 - Tacoma, Washington, United States
- Site 425 - Amman, Jordan
- Site 424 - Amman, Jordan
- Site 421 - Amman, Jordan
- Site 634 - Athens, Greece
- Site 632 - Athens, Greece
- Site 481 - Banja Luka, Bosnia and Herzegovina
- Site 852 - Basel, Switzerland
- Site 445 - Beer Yaaqov, Israel
- Site 441 - Beersheba, Israel
- Trial Site 804 - Belgrade, Serbia
- Site 802 - Belgrade, Serbia
- Site 807 - Belgrade, Serbia
- Site 803 - Belgrade, Serbia
- Site 606 - Berlin, Germany
- Site 613 - Berlin, Germany
- Site 604 - Berlin, Germany
- Site 853 - Bern, Switzerland
- Site 683 - Bologna, Italy
- Site 611 - Brandenburg an der Havel, Germany
- Site 823 - Bratislava, Slovakia
- Site 531 - Brno, Czechia
- Site 475 - Bruges, Belgium
- Site 783 - Bucharest, Romania
- Site 784 - Bucharest, Romania
- Site 781 - Bucharest, Romania
- Site 655 - Budapest, Hungary
- Site 656 - Budapest, Hungary
- Site 651 - Budapest, Hungary
- Site 357 - Busan, South Korea
- Site 753 - Bydgoszcz, Poland
- Site 732 - Bydgoszcz, Poland
- Site 654 - Békéscsaba, Hungary
- Site 394 - Changhua, Taiwan
- Site 631 - Chaïdári, Greece
Showing 60 of 267 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →