Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01694485 · ClinicalTrials.gov registry record · Phase 2
Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 359
- Enrollment target
NCT01694485: Completed Phase 2 study, sponsored by Amgen.
NCT01694485 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 359 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (170% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01694485, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 359 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.
Primary Outcome
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher sc
Interventions
- DRUG Placebo
- BIOLOGICAL Abrilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2012-11-16 |
| Est. Completion | 2018-04-10 |
| Phase | Phase 2 |
What the finished NCT01694485 record still lists
NCT01694485 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (170% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01694485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01694485 about?
NCT01694485 is a clinical study titled "Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis". The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.
What is the current status of trial NCT01694485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 359 participants. The study started on 2012-11-16. Estimated completion is 2018-04-10.
What interventions are being tested in trial NCT01694485?
The interventions under investigation include: Placebo (DRUG), Abrilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01694485?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01694485's enrollment target sits among peer trials
359 127th of 2000 higher than 1,874 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05118789 · 359 participants · Phase 1
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
- NCT02747836 · 360 participants
Ultrasound Analysis of Human Carpal Tunnel System
- NCT04089046 · 360 participants · NA
Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)
- NCT04130503 · 360 participants · NA
The Recovery in Stroke Using PAP Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI