Myasthenia Gravis Inebilizumab Trial

NCT04524273 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: VIB0551.P3.S1
• Study Type: interventional
• Target: 238
• Locations: 19 countries
• Sites: 104

Brief Summary

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population

  MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population.

  Baseline and Week 26

Secondary Outcomes (35)

• Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population

  Baseline and Week 26

• Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations

  Baseline and Week 26

• Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations

  Baseline and Week 26

• Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population

  Up to Week 26

• Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations

  Up to Week 26

Study Arms (4)

Inebilizumab, (AChR-Ab+) MG

EXPERIMENTAL

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Drug: inebilizumab

Placebo, (AChR-Ab+) MG

PLACEBO COMPARATOR

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Drug: IV Placebo

Inebilizumab, (MuSK-Ab+) MG

EXPERIMENTAL

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Drug: inebilizumab

Placebo, (MuSK-Ab+) MG

PLACEBO COMPARATOR

Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Drug: IV Placebo

Interventions

inebilizumab DRUG

Participants will receive IV inebilizumab

Also known as: MEDI-551, VIB0551

Inebilizumab, (AChR-Ab+) MG; Inebilizumab, (MuSK-Ab+) MG

IV Placebo DRUG

Participants will receive IV placebo matched to inebilizumab

Placebo, (AChR-Ab+) MG; Placebo, (MuSK-Ab+) MG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MG with anti-AChR or anti-MuSK antibody.
• MGFA Clinical Classification Class II, III, or IV.
• MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
• QMG score of 11 or greater.
• Participants must be on:
• Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
• One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
• Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
• Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.

You may not qualify if:

• Receipt of the following medications within the 4 weeks prior to Day 1:
• Cyclosporine (except eye drops)
• Tacrolimus (except topical)
• Methotrexate
• Current use of:
• Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
• Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
• Azathioprine \> 3 mg/kilogram (kg)/day
• Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day
• Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Sponsors & Collaborators

• Amgen: lead

Study Sites (104)

Viela Bio Investigative Site - 1015

Orange, California, 92868, United States

Location

Viela Bio Investigative Site - 1002

New Haven, Connecticut, 06519, United States

Location

Viela Bio Investigative Center - 1024

Washington D.C., District of Columbia, 20010, United States

Location

Viela Bio Investigative Site - 1005

Tampa, Florida, 33612, United States

Location

Viela Bio Investigative Site - 1012

Kansas City, Kansas, 66160, United States

Location

Viela Bio Investigative Site - 1018

Charlotte, North Carolina, 28203, United States

Location

Viela Bio Investigative Site - 1025

Canton, Ohio, 44718, United States

Location

Viela Bio Investigative Site - 1001

Cincinnati, Ohio, 45219, United States

Location

Viela Bio Investigative Site - 1009

Columbus, Ohio, 43210, United States

Location

Viela Bio Investigative Site - 1008

Pittsburgh, Pennsylvania, 15212, United States

Location

Viela Bio Investigative Site - 1019

Austin, Texas, 78759, United States

Location

Viela Bio Investigative Site - 1003

Houston, Texas, 77030, United States

Location

Viela Bio Investigative Site - 1014

San Antonio, Texas, 78229, United States

Location

Viela Bio Investigative Site - 1017

Salt Lake City, Utah, 84132, United States

Location

Viela Bio Investigative Site - 1004

Burlington, Vermont, 05401, United States

Location

Viela Bio Investigative Site - 1006

Richmond, Virginia, 23298, United States

Location

Viela Bio Investigative Site - 2001

Buenos Aires, C1023AAB, Argentina

Location

VielaBio Investigative Site - 2002

Buenos Aires, C1199ABB, Argentina

Location

Viela Bio Investigative Site - 2003

Buenos Aires, C1221ADC, Argentina

Location

Viela Bio Investigative Site - 5203

Grodno, 230030, Belarus

Location

Viela Bio Investigative Site - 5204

Minsk, 220114, Belarus

Location

Viela Bio Investigative Site - 5201

Vitebsk, 210009, Belarus

Location

VielaBio Investigative Site - 2201

Porto Alegre, 90035-001, Brazil

Location

VielaBio Investigative Site - 2203

Porto Alegre, 90840-440, Brazil

Location

VielaBio Investigative Site - 2207

Ribeirão Preto, 14051-140, Brazil

Location

VielaBio Investigative Site - 2206

São Paulo, 01228-000, Brazil

Location

Viela Bio Investigative Site - 2205

São Paulo, 08270-120, Brazil

Location

Viela Bio Investigative Site - 1102

Toronto, Ontario, M5G 2C4, Canada

Location

Viela Bio Investigative Site - 1101

Montreal, Quebec, H2X 3J4, Canada

Location

Viela Bio Investigative Site - 1103

Montreal, Quebec, H3A 2B4, Canada

Location

Viela Bio Investigative Site 4009

Beijing, 100029, China

Location

Viela Bio Investigative Site - 4007

Beijing, 100053, China

Location

Viela Bio Investigative Site 4003

Beijing, 100070, China

Location

Viela Bio Investigative Site - 4005

Guiyang, 550004, China

Location

Viela Bio Investigative site 4010

Hunan, 410008, China

Location

Viela Bio Investigative Site - 4011

Jinan, 250012, China

Location

Viela Bio Investigative Site - 4006

Shanghai, 201107, China

Location

Viela Bio Investigative Site - 4008

Suzhou, 215006, China

Location

Viela Bio Investigative Site - 4004

Tianjin, 300052, China

Location

Viela Bio Investigative Site 4012

Xi'an, 710038, China

Location

Viela Bio Investigative Site - 5601

Copenhagen, 2100, Denmark

Location

Viela Bio Investigative Site - 3003

Lille, 59037, France

Location

Viela Bio Investigative Site - 3001

Nice, 06001, France

Location

Viela Bio Investigative Site - 3002

Strasbourg, 67098, France

Location

VielaBio Investigative Site - 3101

Essen, 45122, Germany

Location

Viela Bio Investigative Site - 4107

Nagpur, Maharashtra, 440003, India

Location

Viela Bio Investigative Site - 4113

Nagpur, Maharashtra, 440012, India

Location

Viela Bio Investigative Site - 4112

Hyderabad, Telangana, 500082, India

Location

Viela Bio Investigative Site - 4104

Bangalore, 560002, India

Location

Viela Bio investigative Site - 4105

Lucknow, 226014, India

Location

Viela Bio Investigative Site - 4103

Manipal, 576104, India

Location

Viela Bio Investigative Site - 4102

Nashik, 422002, India

Location

Viela Bio Investigative Site - 4109

Pune, 411004, India

Location

Viela Bio Investigative Site - 4101

Surat, 395002, India

Location

Viela Bio Investigative Site - 3204

Milan, 20122, Italy

Location

Viela Bio Investigative Site - 3203

Milan, 20133, Italy

Location

Viela Bio Investigative Site - 3201

Pavia, 27100, Italy

Location

Viela Bio Investigative Site - 3202

Rome, 168, Italy

Location

Viela Bio Investigative Site - 4402

Chiba, 260-8677, Japan

Location

Viela Bio Investigative Site - 4410

Chiba, 286-8520, Japan

Location

Viela Bio Investigative Site 4409

Fukuoka, 812-8582, Japan

Location

Viela Bio Investigative Site - 4401

Hanamaki, 025-0082, Japan

Location

VielaBio Investigative Site - 4408

Hokkaido, 041-8680, Japan

Location

Viela Bio Investigative Site - 4406

Hyōgo, 663-8501, Japan

Location

Viela Bio Investigative Site 4405

Miyagi, 983-8520, Japan

Location

Viela Bio Investigative Site - 4413

Moriguchi, 570-8507, Japan

Location

VielaBio Investigative Site - 4407

Morioka, 020-8505, Japan

Location

Viela Bio Investigative Site - 4404

Saitama, 350-8550, Japan

Location

Viela Bio Investigative Site - 3302

Katowice, 40-635, Poland

Location

Viela Bio Investigative Site - 3303

Katowice, 40-752, Poland

Location

Viela Bio Investigative Site - 3301

Krakow, 31-505, Poland

Location

Med Polonia Sp. z o.o - 3311

Poznan, 60-693, Poland

Location

Viela Bio Investigative Site - 3310

Warsaw, 01-868, Poland

Location

Viela Bio Investigative Site - 5313

Barnaul, Altayskiy Kray, 656043, Russia

Location

Viela Bio Investigative Site - 5303

Barnaul, 656045, Russia

Location

Viela Bio Investigative Site - 5302

Nizhny Novgorod, 603126, Russia

Location

Viela Bio Investigative Site - 5304

Novosibirsk, 630087, Russia

Location

Viela Bio Investigative Site - 5311

Rostov-on-Don, 344015, Russia

Location

Viela Bio Investigative Site - 5309

Rostov-on-Don, 344022, Russia

Location

Viela Bio Investigative Site - 5308

Saint Petersburg, 197110, Russia

Location

Viela Bio Investigative Site - 5305

Samara, 443095, Russia

Location

Viela Bio Investigative Site - 5312

Ufa, 450083, Russia

Location

Viela Bio Investigative Site - 4202

Seoul, 3722, South Korea

Location

Viela Bio Investigative Site - 4203

Seoul, 5030, South Korea

Location

Viela Bio Investigative Site - 4201

Seoul, 6351, South Korea

Location

Viela Bio Investigative Site - 3403

Badalona, 8916, Spain

Location

Viela Bio Investigative Site - 3402

Barcelona, 8003, Spain

Location

Viela Bio Investigative Site - 3404

Córdoba, 14004, Spain

Location

Viela Bio investigative Site - 4605

Kaohsiung City, 83301, Taiwan

Location

Viela Bio Investigative Site 4608

New Taipei City, 235, Taiwan

Location

Viela Bio Investigative Site - 4606

Tainan, 704, Taiwan

Location

Viela Bio Investigative Site - 4604

Taipei, 10002, Taiwan

Location

Viela Bio Investigative Site - 4603

Taipei, 111, Taiwan

Location

Viela Bio Investigative Site -4607

Taipei, 11217, Taiwan

Location

Viela Bio Investigative Site - 4602

Taoyuan, 333, Taiwan

Location

Viela Bio Investigative Site - 3903

Ankara, 6230, Turkey (Türkiye)

Location

Viela Bio Investigative Site - 3901

Izmir, 35100, Turkey (Türkiye)

Location

Viela Bio Investigative Site - 3902

Izmir, 35330, Turkey (Türkiye)

Location

Viela Bio Investigative Site - 3905

Kocaeli, 41380, Turkey (Türkiye)

Location

Viela Bio Investigative Site - 5103

Dnipro, 49005, Ukraine

Location

Viela Bio Investigative Site - 5108

Dnipro, 49089, Ukraine

Location

Viela Bio Investigative Site - 5105

Ivano-Frankivsk, 76493, Ukraine

Location

Viela Bio Investigative Site - 5104

Lutsk, 43005, Ukraine

Location

Viela Bio Investigative Site - 5106

Vinnytsia, 21050, Ukraine

Location

Related Publications (1)

• Nowak RJ, Benatar M, Ciafaloni E, Howard JF Jr, Leite MI, Utsugisawa K, Vissing J, Rojavin M, Li Q, Tang F, Wu Y, Rampal N, Cheng S; MINT Investigators. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Jun 19;392(23):2309-2320. doi: 10.1056/NEJMoa2501561. Epub 2025 Apr 8.

  PMID: 40202593 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study in which the IV inebilizumab and the IV placebo are matching in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study with Open-label Period

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 24, 2020
• Study Start: October 15, 2020
• Primary Completion: May 28, 2024
• Study Completion (Estimated): November 29, 2027
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-01

Locations

IT (4); JP (10); IN (9); PL (5); RU (9); BR (5); DK (1); DE (1); UA (5); TU (4); AR (3); CA (3); BE (3); KR (3); CN (10); ES (3); FR (3); US (16); TW (7)