Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
NCT06109441 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06109441
The ClinicalTrials.gov registry entry for NCT06109441 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AltruBio, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06109441 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06109441?
The interventions under investigation include: ALTB-268 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06109441?
This trial is sponsored by AltruBio, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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