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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 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.

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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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2023-12-04
Est. Completion 2027-03
Phase Phase 2

Sponsor

AltruBio

5 total trials

What the Registry Record Tells You About NCT06109441

The ClinicalTrials.gov registry entry for NCT06109441 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is AltruBio, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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