N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
2 other identifiers
interventional
231
24 countries
96
Brief Summary
To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2015
Longer than P75 for phase_2
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedResults Posted
Study results publicly available
December 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedDecember 3, 2021
November 1, 2021
3.6 years
July 16, 2014
October 24, 2019
November 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
Day 1 (Baseline) through Day 197
Secondary Outcomes (16)
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
Day 1 (Baseline) through Day 197
Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Day 1 (Baseline) through Day 197
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
From Screening (Day -28) to Day 197
Number of NMOSD-related In-patient Hospitalizations During RCP
Day 1 (Baseline) through Day 197
Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab
For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)
- +11 more secondary outcomes
Study Arms (2)
Placebo/Inebilizumab
PLACEBO COMPARATORAquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab
EXPERIMENTALAQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Interventions
Participants will receive IV inebilizumab 300 mg.
Participants will receive IV placebo matched to inebilizumab.
Eligibility Criteria
You may qualify if:
- Men and women 18 years or older with diagnosis of NMO/NMOSD
- Confirmation of NMO/NMOSD status:
- AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
- AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- EDSS \<= 7.5 (8 in special circumstances)
- Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
You may not qualify if:
- Lactating and pregnant females
- Treatment with any investigational agent within 4 weeks of screening
- Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
- Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
- History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to randomization
- Receipt of the following at any time prior to randomization:
- Alemtuzumab
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
- Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
- Receipt of any of the following within 3 months prior to randomization:
- Natalizumab (Tysabri®).
- Cyclosporin
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (98)
Research Site
Birmingham, Alabama, 35294, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94158, United States
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Aurora, Colorado, 80010, United States
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New Haven, Connecticut, 06511, United States
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Maitland, Florida, 32751, United States
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Chicago, Illinois, 60637, United States
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Kansas City, Kansas, 66160, United States
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Baltimore, Maryland, 21287, United States
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Detroit, Michigan, 48201, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63131-2374, United States
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Raleigh, North Carolina, 27607, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44195, United States
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Mansfield, Ohio, 44906, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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Richmond, Virginia, 23298, United States
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Melbourne, 3065, Australia
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Sofia, 1113, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1431, Bulgaria
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Varna, 9010, Bulgaria
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Vancouver, British Columbia, V6T 2B5, Canada
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Barranquilla, 080020, Colombia
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Bogotá, 110131, Colombia
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Bogotá, 110231, Colombia
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Cali, 760032, Colombia
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Olomouc, 775 20, Czechia
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Prague, 121 11, Czechia
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Teplice, 415 29, Czechia
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Tallinn, 10617, Estonia
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Tartu, 51014, Estonia
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Berlin, 10117, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40225, Germany
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Leipzig, 04103, Germany
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Münster, 48149, Germany
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Rostock, 18147, Germany
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Hong Kong, Hong Kong
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Esztergom, 2500, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6725, Hungary
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Jerusalem, 91120, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Aomori, 030-8553, Japan
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Bunkyō City, 113-8431, Japan
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Kyoto, 604-8453, Japan
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Ōta-ku, 145-0065, Japan
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Sendai, 980-8574, Japan
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Tsukuba, 305-8577, Japan
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Mexico City, 03310, Mexico
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Mexico City, 14269, Mexico
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Monterrey, 64460, Mexico
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San Luis Potosí City, 78090, Mexico
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Chisinau, 2028, Moldova
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Auckland, 1023, New Zealand
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Bellavista, CALLAO 2, Peru
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Lima, LIMA 01, Peru
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Katowice, 40-595, Poland
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Krakow, 31-637, Poland
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Lódz, 90-324, Poland
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Lublin, 20-954, Poland
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Olsztyn, 10-560, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02-957, Poland
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Belgorod, 308007, Russia
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Kazan', 420021, Russia
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Khabarovsk, 680009, Russia
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Krasnoyarsk, 660037, Russia
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Moscow, 123367, Russia
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Moscow, 127018, Russia
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Nizhny Novgorod, 603155, Russia
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Novosibirsk, 63007, Russia
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Omsk, 644033, Russia
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Saint Petersburg, 197110, Russia
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Ufa, 450005, Russia
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Belgrade, 11129, Serbia
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Cape Town, 7505, South Africa
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Cape Town, 7925, South Africa
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Goyang, 410-769, South Korea
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Jongno-gu, 110-744, South Korea
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Seoul, 135-710, South Korea
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Seoul, 143729, South Korea
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Madrid, 28040, Spain
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Changhua, 50006, Taiwan
Research Site
Hualien City, 97002, Taiwan
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Tainan, 70403, Taiwan
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Bangkok, 10700, Thailand
Research Site
Muang, 40002, Thailand
Research Site
Muang, 50200, Thailand
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Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34147, Turkey (Türkiye)
Research Site
Istanbul, 34890, Turkey (Türkiye)
Research Site
Izmir, 35170, Turkey (Türkiye)
Research Site
Samsun, 55139, Turkey (Türkiye)
Related Publications (9)
Cree BAC, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, She D, Rees W, Smith M, Cimbora D, Katz E, Bennett JL; N-MOmentum study investigators. Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial. Lancet Neurol. 2024 Jun;23(6):588-602. doi: 10.1016/S1474-4422(24)00077-2.
PMID: 38760098DERIVEDAktas O, Hartung HP, Smith MA, Rees WA, Fujihara K, Paul F, Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Cutter G, She D, Gunsior M, Cimbora D, Katz E, Cree BA; N-MOmentum study investigators. Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder. J Neurol Neurosurg Psychiatry. 2023 Sep;94(9):757-768. doi: 10.1136/jnnp-2022-330412. Epub 2023 May 23.
PMID: 37221052DERIVEDBennett JL, Aktas O, Rees WA, Smith MA, Gunsior M, Yan L, She D, Cimbora D, Pittock SJ, Weinshenker BG, Paul F, Marignier R, Wingerchuk D, Cutter G, Green A, Hartung HP, Kim HJ, Fujihara K, Levy M, Katz E, Cree BAC; N-MOmentum study investigators. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial. EBioMedicine. 2022 Dec;86:104321. doi: 10.1016/j.ebiom.2022.104321. Epub 2022 Nov 10.
PMID: 36370634DERIVEDFlanagan EP, Levy M, Katz E, Cimbora D, Drappa J, Mealy MA, She D, Cree BAC. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022 Jan;57:103352. doi: 10.1016/j.msard.2021.103352. Epub 2021 Oct 26.
PMID: 35158461DERIVEDMarignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Green AJ, Aktas O, Hartung HP, Lublin FD, Williams IM, Drappa J, She D, Cimbora D, Rees W, Smith M, Ratchford JN, Katz E, Cree BAC; N-MOmentum Study Investigators. Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 26;8(3):e978. doi: 10.1212/NXI.0000000000000978. Print 2021 May.
PMID: 33771837DERIVEDAktas O, Smith MA, Rees WA, Bennett JL, She D, Katz E, Cree BAC; N-MOmentum scientific group and the N-MOmentum study investigators. Serum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker. Ann Neurol. 2021 May;89(5):895-910. doi: 10.1002/ana.26067. Epub 2021 Mar 30.
PMID: 33724534DERIVEDCree BA, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Williams IM, Drappa J, She D, Cimbora D, Rees W, Ratchford JN, Katz E. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD. Mult Scler. 2021 Nov;27(13):2052-2061. doi: 10.1177/1352458521988926. Epub 2021 Feb 4.
PMID: 33538237DERIVEDCree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5.
PMID: 31495497DERIVEDCree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14.
PMID: 26666258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In the safety follow-up period (SFP), only 1 participant from 'Placebo/Inebilizumab' arm rolled over to SFP and no participant from 'Inebilizumab /Inebilizumab' arm rolled over to SFP. For EudraCT result posting, a study period with any one of the arm with zero participants started is not acceptable (EudraCT limitation). Therefore, not included SFP in 'Participant Flow' section to keep the data consistent across registry portals.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical study Information Center
Study Officials
- STUDY DIRECTOR
MedImmune, LLC MedImmune, LLC
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 25, 2014
Study Start
April 1, 2015
Primary Completion
October 26, 2018
Study Completion
November 6, 2020
Last Updated
December 3, 2021
Results First Posted
December 26, 2019
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared