Myasthenia Gravis Inebilizumab Trial

Myasthenia Gravis Clinical Trial

— MINT  

Official title:

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04524273
• Other study ID #: VIB0551.P3.S1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 30, 2020
• Est. completion date: November 29, 2027

Study information

• Verified date: March 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 230 participants (188 acetylcholine receptor antibody positive [AChR-Ab+] and 42 muscle-specific tyrosine kinase antibody positive [MuSK-Ab+]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score >=11, Quantitative Myasthenia Gravis (QMG) score >= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period. Study acquired from Horizon in 2024.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: November 29, 2027
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of MG with anti-AChR or anti-MuSK antibody.

2. MGFA Clinical Classification Class II, III, or IV.

3. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.

4. QMG score of 11 or greater.

5. Participants must be on:

1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or

2. 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

3. 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.

Exclusion Criteria:

1. Receipt of the following medications within the 4 weeks prior to Day 1:

1. Cyclosporine (except eye drops)

2. Tacrolimus (except topical)

3. Methotrexate

2. Current use of:

1. Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids).

2. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.

3. Azathioprine > 3 mg/kilogram (kg)/day

4. Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day

5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• inebilizumab
Participants will receive IV inebilizumab
• IV Placebo
Participants will receive IV placebo matched to inebilizumab

Locations

Country	Name	City	State
Argentina	Viela Bio Investigative Site - 2001	Buenos Aires
Argentina	Viela Bio Investigative Site - 2003	Buenos Aires
Argentina	VielaBio Investigative Site - 2002	Buenos Aires
Belarus	Viela Bio Investigative Site - 5203	Grodno
Belarus	Viela Bio Investigative Site - 5204	Minsk
Belarus	Viela Bio Investigative Site - 5201	Vitebsk
Brazil	VielaBio Investigative Site - 2201	Porto Alegre
Brazil	VielaBio Investigative Site - 2203	Porto Alegre
Brazil	VielaBio Investigative Site - 2207	Ribeirão Preto
Brazil	VielaBio Investigative Site - 2206	San Paolo
Brazil	Viela Bio Investigative Site - 2205	São Paulo
Canada	Viela Bio Investigative Site - 1101	Montréal	Quebec
Canada	Viela Bio Investigative Site - 1103	Montréal	Quebec
Canada	Viela Bio Investigative Site - 1102	Toronto	Ontario
China	Viela Bio Investigative Site - 4007	Beijing
China	Viela Bio Investigative Site 4003	Beijing
China	Viela Bio Investigative Site 4009	Beijing
China	Viela Bio Investigative Site - 4005	Guiyang
China	Viela Bio Investigative site 4010	Hunan
China	Viela Bio Investigative Site - 4011	Jinan
China	Viela Bio Investigative Site - 4006	Shanghai
China	Viela Bio Investigative Site - 4008	Suzhou
China	Viela Bio Investigative Site - 4004	Tianjin
China	Viela Bio Investigative Site 4012	Xi'an
Denmark	Viela Bio Investigative Site - 5601	Copenhagen
France	Viela Bio Investigative Site - 3003	Lille Cedex
France	Viela Bio Investigative Site - 3001	Nice Cedex 01
France	Viela Bio Investigative Site - 3002	Strasbourg
Germany	VielaBio Investigative Site - 3101	Essen
India	Viela Bio Investigative Site - 4104	Bangalore
India	Viela Bio Investigative Site - 4112	Hyderabad	Telangana
India	Viela Bio investigative Site - 4105	Lucknow
India	Viela Bio Investigative Site - 4103	Manipala
India	Viela Bio Investigative Site - 4113	Nagpur	Maharashtra
India	Viela Bio Investigative Site - 4102	Nashik
India	Viela Bio Investigative Site - 4109	Pune
India	Viela Bio Investigative Site - 4101	Surat
Italy	Viela Bio Investigative Site - 3203	Milano
Italy	Viela Bio Investigative Site - 3204	Milano
Italy	Viela Bio Investigative Site - 3201	Pavia
Italy	Viela Bio Investigative Site - 3202	Rome
Japan	Viela Bio Investigative Site - 4402	Chiba
Japan	Viela Bio Investigative Site - 4410	Chiba
Japan	Viela Bio Investigative Site 4409	Fukuoka
Japan	Viela Bio Investigative Site - 4401	Hanamaki
Japan	VielaBio Investigative Site - 4408	Hokkaido
Japan	Viela Bio Investigative Site - 4406	Hyogo
Japan	Viela Bio Investigative Site 4405	Miyagi
Japan	Viela Bio Investigative Site - 4413	Moriguchi
Japan	VielaBio Investigative Site - 4407	Morioka-shi
Japan	Viela Bio Investigative Site - 4404	Saitama
Korea, Republic of	Viela Bio Investigative Site - 4201	Seoul
Korea, Republic of	Viela Bio Investigative Site - 4202	Seoul
Korea, Republic of	Viela Bio Investigative Site - 4203	Seoul
Poland	Viela Bio Investigative Site - 3302	Katowice
Poland	Viela Bio Investigative Site - 3303	Katowice
Poland	Viela Bio Investigative Site - 3301	Kraków
Poland	Med Polonia Sp. z o.o - 3311	Poznan
Poland	Viela Bio Investigative Site - 3311	Poznan
Poland	Viela Bio Investigative Site - 3310	Warszawa
Russian Federation	Viela Bio Investigative Site - 5303	Barnaul
Russian Federation	Viela Bio Investigative Site - 5302	Nizhny Novgorod
Russian Federation	Viela Bio Investigative Site - 5304	Novosibirsk
Russian Federation	Viela Bio Investigative Site - 5309	Rostov-on-Don
Russian Federation	Viela Bio Investigative Site - 5311	Rostov-on-Don
Russian Federation	Viela Bio Investigative Site - 5308	Saint Petersburg
Russian Federation	Viela Bio Investigative Site - 5305	Samara
Russian Federation	Viela Bio Investigative Site - 5312	Ufa
Spain	Viela Bio Investigative Site - 3403	Badalona
Spain	Viela Bio Investigative Site - 3402	Barcelona
Spain	Viela Bio Investigative Site - 3404	Córdoba
Taiwan	Viela Bio investigative Site - 4605	Kaohsiung City
Taiwan	Viela Bio Investigative Site 4608	New Taipei City
Taiwan	Viela Bio Investigative Site - 4606	Tainan
Taiwan	Viela Bio Investigative Site - 4603	Taipei
Taiwan	Viela Bio Investigative Site - 4604	Taipei
Taiwan	Viela Bio Investigative Site -4607	Taipei
Taiwan	Viela Bio Investigative Site - 4602	Taoyuan City
Turkey	Viela Bio Investigative Site - 3903	Ankara
Turkey	Viela Bio Investigative Site - 3901	Izmir
Turkey	Viela Bio Investigative Site - 3902	Izmir
Turkey	Viela Bio Investigative Site - 3905	Kocaeli
Ukraine	Viela Bio Investigative Site - 5103	Dnipro
Ukraine	Viela Bio Investigative Site - 5105	Ivano-Frankivs'k
Ukraine	Viela Bio Investigative Site - 5104	Lutsk
Ukraine	Viela Bio Investigative Site - 5106	Vinnytsia
United States	Viela Bio Investigative Site - 1016	Augusta	Georgia
United States	Viela Bio Investigative Site - 1019	Austin	Texas
United States	Viela Bio Investigative Site - 1004	Burlington	Vermont
United States	Viela Bio Investigative Site - 1025	Canton	Ohio
United States	Viela Bio Investigative Site - 1018	Charlotte	North Carolina
United States	Viela Bio Investigative Site - 1001	Cincinnati	Ohio
United States	Viela Bio Investigative Site - 1009	Columbus	Ohio
United States	Viela Bio Investigative Site - 1003	Houston	Texas
United States	Viela Bio Investigative Site - 1012	Kansas City	Kansas
United States	Viela Bio Investigative Site - 1002	New Haven	Connecticut
United States	Viela Bio Investigative Site - 1015	Orange	California
United States	Viela Bio Investigative Site - 1008	Pittsburgh	Pennsylvania
United States	Viela Bio Investigative Site - 1006	Richmond	Virginia
United States	Viela Bio Investigative Site - 1017	Salt Lake City	Utah
United States	Viela Bio Investigative Site - 1014	San Antonio	Texas
United States	Viela Bio Investigative Site - 1005	Tampa	Florida
United States	Viela Bio Investigative Center - 1024	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Belarus,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  India,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.		Week 26 for the overall study population
Secondary	Change in Quantitative Myasthenia Gravis (QMG) scores.		Week 26 for the overall study population, the AChR-Ab+ population and for the MuSK-Ab+ population
Secondary	Proportion of participants with both = 3-point improvement in MG-ADL and did not initiate rescue therapy.		Between Day 28 and Week 52 for AChR-Ab+ population and Day 28 and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Change in MG-ADL at Week 26		Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Time to first gMG exacerbation.		Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Change in Myasthenia Gravis Composite (MGC) score.		Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.		Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Change in Patient Global Impression of Change (PGIC) score.		Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population
Secondary	Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the RCP and OLP.		Until Week 156 the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population