Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (OASIS(CM))

January 14, 2026 updated by: Amgen

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 subjects; 12-weeks for Group 2 subjects) in which participants receive placebo or erenumab dose 1, dose 2 or dose 3 (based on participant's body-weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug). The study intends to enrol 286 participants (256 adolescents and 30 children).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Mechelen, Belgium, 2800
        • Algemeen Ziekenhuis Sint-Maarten
      • Saint-Nicolas, Belgium, 4420
        • Docteur Simona Sava
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Stollery Childrens Hospital
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L1
        • Childrens Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Fundacion Centro de Investigacion Clinica
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111211
        • Cafam
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 681017
        • Fundacion cardiovascular de Colombia
  • Finland
      • Turku, Finland, 20100
        • Terveystalo Pulssi
  • Germany
      • Berlin, Germany, 13353
        • Charite - Universitaetsmedizin Berlin, Campus Virchow
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Kiel, Germany, 24149
        • Schmerzklinik Kiel
      • Leipzig, Germany, 04107
        • Arzneimittelforschung Leipzig GmbH
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Dr Kenessey Albert Korhaz - Rendelointezet
      • Budapest, Hungary, 1094
        • Semmelweis Egyetem
      • Budapest, Hungary, 1027
        • High Tech Medical Kft
      • Budapest, Hungary, 1026
        • Dr Altmann Anna egyeni vallalkozo
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungary, 3526
        • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház
  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Palermo, Italy, 90134
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
      • Roma, Italy, 00165
        • Irccs Ospedale Pediatrico Bambino Gesu
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 451-0031
        • Josai Kids Clinic
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0925
        • Medical Corporation Seikokai Takanoko Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0004
        • Kitami Clinic
    • Hyōgo
      • Kobe, Hyōgo, Japan, 658-0064
        • Konan Medical Center
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 862-8505
        • Kumamoto City Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 600-8811
        • Tatsuoka Neurology Clinic
      • Kyoto, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 982-0014
        • Sendai Headache and Neurology Clinic
    • Osaka
      • Osaka, Osaka, Japan, 556-0017
        • Tominaga Hospital
    • Saitama
      • Saitama-shi, Saitama, Japan, 338-8577
        • Saitama Neuropsychiatric Institute
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Tokyo Headache Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
    • Yamaguchi
      • Hofu-shi, Yamaguchi, Japan, 747-0802
        • Nagamitsu Clinic
    • Yamanashi
      • Kai-shi, Yamanashi, Japan, 400-0124
        • Nagaseki Headache Clinic
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Lublin, Poland, 20-701
        • Centrum Medyczne Hope Clinic Sebastian Szklener
      • Lublin, Poland, 20-109
        • Centrum Medyczne Luxmed Spzoo
      • Poznan, Poland, 61-731
        • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
      • Poznan, Poland, 60-355
        • Uniwersytecki Szpital Kliniczny W Poznaniu
      • Warsaw, Poland, 01-018
        • Dr Sękowska Leczenie Bólu
      • Warsaw, Poland, 02-121
        • Next Stage Spzoo
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health and Wellness Institute
  • Russia
      • Moscow, Russia, 119571
        • FSBI Russian Children Clinical Hospital of the MoH RF
      • Moscow, Russia, 125047
        • LLC clinic Chaika
      • Novosibirsk, Russia, 630004
        • LLC Sibneyromed
      • Saint Petersburg, Russia, 191025
        • LLC Medical Technologies
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Noahs Ark Childrens Hospital for Wales
      • Glasgow, United Kingdom, G51 4TF
        • Royal Hospital for Children
      • Ilford, United Kingdom, IG1 4HP
        • 4 Medical Clinical Solutions London
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Childrens Hospital
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital for Children
      • London, United Kingdom, SE1 7EU
        • Evelina Childrens Hospital
      • Manchester, United Kingdom, M27 8FF
        • 4 Medical Clinical Solutions Manchester
      • Oxford, United Kingdom, OX3 9DU
        • Oxford Childrens Hospital
  • United States
    • California
      • San Diego, California, United States, 92108
        • Paradigm Clinical Research Center Inc
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Childrens Hospital Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Childrens National Health System
    • Florida
      • Brandon, Florida, United States, 33511
        • TrueBlue Clinical Research
      • Gulf Breeze, Florida, United States, 32561
        • Northwest Florida Clinical Research Group Limited Liability Company
      • Miami, Florida, United States, 33155
        • Nicklaus Childrens Hospital
      • Tampa, Florida, United States, 33609
        • Pediatric Epilepsy and Neurology Specialists
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Rare Disease Research Center Pediatrics
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60657
        • Chicago Headache Center and Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • Massachusetts
      • Worcester, Massachusetts, United States, 14226
        • New England Regional Headache Center Inc
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain and Neurological Institute
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute Inc
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Childrens Mercy Hospital and Clinics
      • St Louis, Missouri, United States, 63141
        • Mercy Research
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research LLC
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10001
        • Modern Migraine MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43205
        • Nationwide Childrens Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Inc
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Palmetto Gastroenterology Clinical Research, LLC
    • Texas
      • Austin, Texas, United States, 78757
        • Child Neurology Consultants of Austin
      • Burleson, Texas, United States, 76028
        • Helios Clinical Research Inc
      • Frisco, Texas, United States, 75033
        • Stryde Consulting LLC
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Childrens Specialty Group
    • West Virginia
      • Crab Orchard, West Virginia, United States, 25827
        • Vaught Neurological Services
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
  • Participant's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
  • History of migraine (with or without aura) for ≥ 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine.
  • History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the participant as migraine days per month in each of the 3 months prior to screening.
  • Migraine frequency: greater than or equal to 8 migraine days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration.
  • Headache frequency of greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration.
  • Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase).

Key Exclusion Criteria:

  • History of cluster headache or hemiplegic migraine headache.
  • Chronic migraine with continuous pain, in which the participant does not have any pain free periods (of any duration) during the 1 month prior to screening.
  • No therapeutic response with greater than 3 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
  • History of suicidal behavior or the participant is at risk of self-harm or harm to others.
  • History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [PHQ-A] score 9 for adolescents or based on medical judgement of the investigator for children) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participants must have been on a stable dose within the 3 months before the start of the baseline phase.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Placebo matching dose for erenumab dose 1, 2 and 3.
Experimental: Dose Level 1
Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Drug: Erenumab Dose 1
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Other Names:
  • AMG 334
  • Aimovig®
Drug: Erenumab Dose 2
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Other Names:
  • AMG 334
  • Aimovig®
Experimental: Dose Level 2
Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Drug: Erenumab Dose 2
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Other Names:
  • AMG 334
  • Aimovig®
Drug: Erenumab Dose 3
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Other Names:
  • AMG 334
  • Aimovig®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in MMDs
Time Frame: Baseline through week 12 of DBTP
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of DBTP.
Baseline through week 12 of DBTP

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in monthly headache days from baseline
Time Frame: Baseline through week 12 of the DBTP
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of DBTP.
Baseline through week 12 of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline
Time Frame: Baseline through week 12 of the DBTP
To evaluate the effect of erenumab compared with placebo on the proportion of participants with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP.
Baseline through week 12 of the DBTP
Change in MMDs from baseline to the average of the first 3 months
Time Frame: Baseline through week 12 of the DBTP
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the DBTP.
Baseline through week 12 of the DBTP
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Time Frame: Baseline through week 12 of the double blind treatment phase
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP. This will be measured in an electronic diary (eDiary) with a visual analogue scale.
Baseline through week 12 of the double blind treatment phase
Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Time Frame: Baseline through week 12 of the DBTP
To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to week 9 through week 12 (month 3) of the DBTP.
Baseline through week 12 of the DBTP
Number of participants experiencing Treatment-emergent Adverse Events (TEAE)
Time Frame: Up to Week 83
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Up to Week 83
Number of participants expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers
Time Frame: Up to week 83
Up to week 83
Number of participants expressing Procollagen Type 1 N Propeptide (P1NP) Markers
Time Frame: Up to week 83
Up to week 83
Number of participants expressing Anti-erenumab antibodies
Time Frame: Up to week 83
Up to week 83
Change in growth and development rate as assessed by physical measuraments based on age-adjusted Z-scores for height and weight
Time Frame: Up to week 83
Up to week 83
Number of participants experiencing treatment-emergent suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
Time Frame: Up to week 83
Up to week 83
Group 1 only: Number of participants experiencing injection site pain as assessed by Face Pain Scale-revised (FPS-R)
Time Frame: Day 1 and week 20
Day 1 and week 20
Group 2 only: Number of participants experiencing injection site pain as assessed by FPS-R
Time Frame: Day 1 and week 8
Day 1 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20160354
  • 2023-504928-26 (EudraCT Number)
  • EMEA-001664-PIP02-15 (Other Identifier: EMEA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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