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

NCT ID: NCT03920293

Last Updated: 2024-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-12

Study Completion Date

2023-05-25

Brief Summary

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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).

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Detailed Description

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Conditions

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Generalized Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Ravulizumab

Participants will receive ravulizumab for the duration of the study.

Group Type EXPERIMENTAL

Ravulizumab

Intervention Type BIOLOGICAL

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Other Intervention Names

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ALXN1210 Ultomiris

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Irvine, California, United States

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Loma Linda, California, United States

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Palo Alto, California, United States

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San Francisco, California, United States

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Sylmar, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Fort Collins, Colorado, United States

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Fairfield, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Rolling Meadows, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Ann Arbor, Michigan, United States

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East Lansing, Michigan, United States

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Grand Rapids, Michigan, United States

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Columbia, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Great Neck, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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North Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Round Rock, Texas, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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Vienna, , Austria

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Brno, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Arhus C, , Denmark

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Copenhagen, , Denmark

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Garches, , France

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Lille, , France

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Marseille, , France

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Nice, , France

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Berlin, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Münster, , Germany

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Würzburg, , Germany

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Haifa, , Israel

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Tel Aviv, , Israel

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Bergamo, , Italy

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Bologna, , Italy

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Milan, , Italy

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Napoli, , Italy

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Roma, , Italy

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Rome, , Italy

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Bunkyō City, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hanamaki-shi, , Japan

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Kawagoe-shi, , Japan

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Moriguchi-shi, , Japan

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Nagoya, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Shinjuku-ku, , Japan

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Ube-shi, , Japan

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Amsterdam, , Netherlands

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Leiden, , Netherlands

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Porto, , Portugal

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Daegu, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Yangsan, , South Korea

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Barcelona, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Zurich, , Switzerland

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Countries

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United States Austria Canada Czechia Denmark France Germany Israel Italy Japan Netherlands Portugal South Korea Spain Switzerland

References

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Vu T, Ortiz S, Katsuno M, Annane D, Mantegazza R, Beasley KN, Aguzzi R, Howard JF Jr. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023 Jun;270(6):3129-3137. doi: 10.1007/s00415-023-11617-1. Epub 2023 Mar 9.

Reference Type DERIVED
PMID: 36890354 (View on PubMed)

Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.

Reference Type DERIVED
PMID: 38319212 (View on PubMed)

Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.

Reference Type DERIVED
PMID: 37103755 (View on PubMed)

Vanoli F, Mantegazza R. Ravulizumab for the treatment of myasthenia gravis. Expert Opin Biol Ther. 2023 Mar;23(3):235-241. doi: 10.1080/14712598.2023.2185131. Epub 2023 Mar 8.

Reference Type DERIVED
PMID: 36852670 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ALXN1210-MG-306&attachmentIdentifier=f164e5fa-8534-413e-a765-e3c6b87e017c&fileName=ALXN1210-MG-306_CSR_Synopsis_redacted.pdf&versionIdentifier=

Related Info

Other Identifiers

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2018-003243-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALXN1210-MG-306

Identifier Type: -

Identifier Source: org_study_id

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