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An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201262
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Biological: Ravulizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: External Placebo-Controlled, Open-Label Design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Experimental: Ravulizumab

During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The Primary Treatment Period will continue until the last enrolled participant completes Week 26 in the study (expected to be approximately 2 years after the first participant is enrolled).

After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 2 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.

Biological: Ravulizumab
Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Other Names:
  • ALXN1210
  • Ultomiris




Primary Outcome Measures :
  1. Time To First Adjudicated On-Trial Relapse [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]

Secondary Outcome Measures :
  1. Incidence Of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, And TEAEs Leading To Study Drug Discontinuation [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
  2. Adjudicated On-Trial Annualized Relapse Rate [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]
  3. Clinically Important Worsening In Expanded Disability Status Scale [ Time Frame: Baseline, up to 2 years (end of the Primary Treatment Period) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
  2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.
  3. Expanded Disability Status Scale score ≤7.
  4. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
  5. Body weight ≥40 kilograms.
  6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  1. History of neisseria meningitidis infection.
  2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
  3. Previously or currently treated with a complement inhibitor.
  4. Use of rituximab or mitoxantrone within 3 months prior to Screening.
  5. Use of IV immunoglobulin within 3 weeks prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201262


Contacts
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Contact: Alexion Pharmaceuticals Inc. 855-752-2356 clinicaltrials@alexion.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04201262    
Other Study ID Numbers: ALXN1210-NMO-307
CHAMPION-NMO-307 ( Other Identifier: Alexion Pharmaceuticals )
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Devic's Disease
Transverse Myelitis
Optic Neuritis
Relapse
Ravulizumab
Ultomiris
ALXN1210
CNS Autoimmune Disorders
Demyelinating Disorders
NMO
NMOSD
Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs