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NCT06109441Not yet recruiting

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

Phase 2a, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of ALTB-268 in Subjects With Moderately to Severely Active Ulcerative Colitis Refractory to Biologic Therapy
AltruBio Inc.Phase 2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
ALTB-268
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
AltruBio Inc.
Location
Wellington,Garland,Lubbock,Mansfield,San Antonio,Tyler,Webster,Toronto, Canada,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 01, 2023
End date
Mar 01, 2026
Enrollment
15 participants
Primary outcome

Efficacy - change in mMS at week 12

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, and a Maintenance Phase.
 
 Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by
 weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week
 12.
 
 Week 12 dosing will occur during the 40 wks Maintenance Phase.
 
 During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other
 week. At week 52, all subjects will have an endoscopy performed and efficacy and safety
 evaluation will take place.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06109441
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06109441 through Pure Global AI's free database. This Phase 2 trial is sponsored by AltruBio Inc. and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 15 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.