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

NCT06109441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-05

No results posted yet for this 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 and a LTE (Long Term Extension)

Conditions

Interventions

BIOLOGICAL

ALTB-268

ALTB-268 drug product (DP) for SC injection is supplied as a sterile and preservative-free frozen solution or lyophilized powder. All excipients used in the DP formulation are of multi-compendial quality and have precedence for use in parenteral products.

Sponsors & Collaborators

  • AltruBio Inc.

    lead INDUSTRY

Principal Investigators

  • David Lin, MD, PhD · AltruBio Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-03-05
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109441 on ClinicalTrials.gov