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NCT06109441 · ClinicalTrials.gov registry record · Phase 2
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
A Phase 2 study of Ulcerative Colitis, sponsored by AltruBio.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06109441: Active Phase 2 study of Ulcerative Colitis, sponsored by AltruBio.
NCT06109441 is a Phase 2 study of Ulcerative Colitis that is active but no longer recruiting, run by AltruBio. The registered enrollment target is 50 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06109441, a Phase 2 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by AltruBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, a Maintenance Phase, and an OLE.
Primary Outcome
Change from baseline in mMS at Week 12. The modified Mayo score (mMayo Score) is a measure of disease activity in ulcerative colitis. It is based on stool frequency (SF), rectal bleeding (RB), and endoscopic subscore (ES). The mMS ranges from 0 to 9. A lower mMS means less severe UC, and a higher mMS means more severe UC.
Conditions Studied
Interventions
- BIOLOGICAL ALTB-268
Study Locations (20)
Texas
- DHAT / GI Aliance - Garland
- Caprock Gastro Reasearch - Lubbock
- GI Alliance - Mansfield
- Southern Star Research Institute LLC - San Antonio
Florida
- Gastro Health Research - Miami
- Digestive and Liver Center of Florida, LLC - Orlando
- Alliance Clinical Research of Tampa, LLC. - Tampa
New York
- New York Presbyterian Hospital - Weill Cornell Medical Colllege - New York
- Gastroenterology Group of Rochester - Rochester
- Digestive Disease Medicine of Central New York - Utica
Ohio
- Dayton Gastroenterology, LLC - Beavercreek
- Gastro Health Ohio - Liberty Township
California
- San Diego Gastroenterology - San Diego
Colorado
- Rocky Mountain Gastroenterology - Littleton
Indiana
- Gastro Health Partners Southern Indiana - New Albany
Kentucky
- Gastro Health Partners Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT06109441 still lists
NCT06109441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which ALTB-268 is the first listed.
NCT06109441 names 20 study sites across 12 states, led by Texas, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06109441 about?
NCT06109441 is a clinical study titled "Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics". ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, a Maintenance Phase, and an OLE.
What is the current status of trial NCT06109441?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-12-04. Estimated completion is 2027-03.
What conditions does trial NCT06109441 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06109441?
The interventions under investigation include: ALTB-268 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06109441?
This trial is sponsored by AltruBio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06109441 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06109441's enrollment target sits among peer trials
50 87th of 122 higher than 35 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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