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NCT03759288 · ClinicalTrials.gov registry record · Phase 2

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2 study, sponsored by AstraZeneca.

Terminated
Registry status
Phase 2
Development phase
89
Enrollment target

NCT03759288: Clinical Trial Phase 2 study, sponsored by AstraZeneca.

NCT03759288 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03759288, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.

TERMINATED
Registry status
Phase 2
Development phase
89 participants
Enrollment target

Study Summary

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Primary Outcome

CDAI remission is defined as \- CDAI score \< 150 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Interventions

  • DRUG Placebo
  • DRUG Humira®
  • DRUG Brazikumab low dose
  • DRUG Brazikumab high dose

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2018-12-07
Est. Completion 2023-10-18
Phase Phase 2
AstraZeneca

1,285 total trials

Why NCT03759288 stopped before completion

NCT03759288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03759288 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03759288 about?

NCT03759288 is a clinical study titled "An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease". This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal...

What is the current status of trial NCT03759288?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2018-12-07. Estimated completion is 2023-10-18.

What interventions are being tested in trial NCT03759288?

The interventions under investigation include: Placebo (DRUG), Humira® (DRUG), Brazikumab low dose (DRUG), Brazikumab high dose (DRUG).

Who is sponsoring clinical trial NCT03759288?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03759288's enrollment target sits among peer trials

89 802nd of 2000 higher than 1,198 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 NCT03759288, the US trial registry maintained by the National Library of Medicine. NCT03759288 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.