Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Public ClinicalTrials.gov record NCT05570006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed. ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally. Participants will receive oral capsules of ABBV-668 twice daily for 16 weeks and will undergo a 30 day follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05570006
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2023
- Primary completion
- Dec 22, 2024
- Completion
- Dec 22, 2024
- Last update posted
- Dec 22, 2025
2023 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gastro SB /ID# 249271 | Chula Vista | California | 91910-5619 | — |
| Ctr for Advanced Gastroenterol /ID# 249226 | Maitland | Florida | 32751-6108 | — |
| Atlantic Medical Research /ID# 249213 | Margate | Florida | 33063-5737 | — |
| Endoscopic Research, Inc. /ID# 249202 | Orlando | Florida | 32803 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 249278 | Macon | Georgia | 31201 | — |
| NYU Langone Long Island Clinical Research Associates /ID# 250075 | Lake Success | New York | 11042 | — |
| Columbia University Medical Center /ID# 250189 | New York | New York | 10032-3729 | — |
| Lenox Hill Hospital /ID# 250008 | New York | New York | 10075 | — |
| Atrium Health /ID# 249273 | Charlotte | North Carolina | 28204-2963 | — |
| Options Health Research, LLC /ID# 249216 | Tulsa | Oklahoma | 74104 | — |
| University of Pennsylvania /ID# 250012 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079 | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh MC /ID# 250071 | Pittsburgh | Pennsylvania | 15260 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 249217 | Greenville | South Carolina | 29607 | — |
| Quality Medical Research /ID# 251125 | Nashville | Tennessee | 37211 | — |
| Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208 | Garland | Texas | 75044 | — |
| Baylor College of Medicine /ID# 249203 | Houston | Texas | 77030 | — |
| Southern Star Research Institute, LLC /ID# 249212 | San Antonio | Texas | 78229-5390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05570006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2025 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05570006 live on ClinicalTrials.gov.