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NCT01150890 · ClinicalTrials.gov registry record · Phase 2

Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

A Phase 2 study, sponsored by Amgen.

Terminated
Registry status
Phase 2
Development phase
130
Enrollment target

NCT01150890: Clinical Trial Phase 2 study, sponsored by Amgen.

NCT01150890 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01150890, a Phase 2 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 2
Development phase
130 participants
Enrollment target

Study Summary

The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Primary Outcome

Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, wit

Interventions

  • DRUG Placebo
  • BIOLOGICAL Brodalumab

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2010-11-09
Est. Completion 2011-10-15
Phase Phase 2
Amgen

558 total trials

Why NCT01150890 stopped before completion

NCT01150890 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01150890 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01150890 about?

NCT01150890 is a clinical study titled "Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease". The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will kno...

What is the current status of trial NCT01150890?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2010-11-09. Estimated completion is 2011-10-15.

What interventions are being tested in trial NCT01150890?

The interventions under investigation include: Placebo (DRUG), Brodalumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01150890?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01150890's enrollment target sits among peer trials

130 543rd of 2000 higher than 1,448 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 NCT01150890, the US trial registry maintained by the National Library of Medicine. NCT01150890 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.