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Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

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: NCT03920293
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Description
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Brief Summary:
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Biological: Ravulizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ravulizumab
Participants will receive ravulizumab for the duration of the study.
 Biological: Ravulizumab
Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Other Names:
  • ALXN1210
  • Ultomiris
Placebo Comparator: Placebo
Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.
 Drug: Placebo
Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile.


Secondary Outcome Measures :
  1. Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score.

  2. Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-QOL15r score

  3. Change From Baseline In The Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score of at least 3 points At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL total score

  4. Change From Baseline In the The Quantitative Myasthenia Gravis (QMG) total score by at least 5 points At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score


Eligibility Criteria
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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. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
  2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
  3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
  4. Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).

Exclusion Criteria:

Medical Conditions

  1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
  2. History of thymectomy within the 12 months prior to screening.
  3. History of N meningitidis infection.

  4. Use of the following within the time period specified below:

    • IV immunoglobulin within 4 weeks of randomization
    • Use of plasma exchange within 4 weeks of randomization
    • Use of rituximab within 6 months of screening
  5. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Contacts and Locations
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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): NCT03920293


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

Locations
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Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03920293    
Other Study ID Numbers: ALXN1210-MG-306
2018-003243-39 ( EudraCT Number )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
 Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs