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NCT03298022 · ClinicalTrials.gov registry record · Phase 2

Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC

A Phase 2 study, sponsored by AltruBio.

Terminated
Registry status
Phase 2
Development phase
24
Enrollment target

NCT03298022: Clinical Trial Phase 2 study, sponsored by AltruBio.

NCT03298022 is a Phase 2 study that was terminated before completion, run by AltruBio. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03298022, a Phase 2 study, was terminated before completion, sponsored by AltruBio.

TERMINATED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.

Primary Outcome

The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 poin

Interventions

  • BIOLOGICAL ALTB-168

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-05-04
Est. Completion 2020-06-01
Phase Phase 2
AltruBio

5 total trials

Why NCT03298022 stopped before completion

NCT03298022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 1 intervention - of which ALTB-168 is the first listed.

NCT03298022 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03298022 about?

NCT03298022 is a clinical study titled "Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC". To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.

What is the current status of trial NCT03298022?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-05-04. Estimated completion is 2020-06-01.

What interventions are being tested in trial NCT03298022?

The interventions under investigation include: ALTB-168 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03298022?

This trial is sponsored by AltruBio, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03298022's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03298022, the US trial registry maintained by the National Library of Medicine. NCT03298022 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.