Phase
Condition
Amyotrophic Lateral Sclerosis (Als)
Myasthenia Gravis (Chronic Weakness)
Scar Tissue
Treatment
VHB837
Placebo
VHB937
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
are 18 years of age or older
male or female, if of childbearing potential, strict contraception required
have ALS confirmed by the trial doctors using different tests.
have mild symptoms of ALS as measured by the ALSFRS-R questionnaire (total score >=30).
have had symptoms of ALS (weakness) within 24 months of taking part in this trial.
have not received treatment for ALS or are currently on a stable dose of an approvedtreatment for ALS.
have the ability to slowly exhale a volume of air at least 60% of what is expectedfor the participant's sex, height and age.
Exclusion
Exclusion Criteria:
Use of other investigational drugs within 5 half-lives of screening, or within 30days (e.g., small molecules) / or until the expected pharmacodynamic effect hasreturned to baseline (e.g., biologics), whichever is longer; or longer if requiredby local regulations.
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for 24 weeks after stopping study medication.
History or current diagnosis of cardiac conditions or ECG abnormalities indicatingsignificant risk of safety for participants in the study.
Clinical evidence of liver or renal disease/injury.
Laboratory evidence of hematological abnormalities
Presence of unstable psychiatric disease, cognitive impairment, neurological diseaseother than ALS, dementia or substance abuse that would impair ability of theparticipant to provide informed consent, in the investigator's opinion.
Participants that reported 'yes' on any suicidal ideation section except for the "Non-Suicidal Self-Injurious Behavior" in the past 2 years as per C-SSRS.
Presence of cancer, HIV, Hep B, Hep C, tuberculosis, uncontrolled diabetes
History of active severe respiratory disease, including Chronic ObstructivePulmonary Disease, interstitial lung disease or pulmonary fibrosis.
Taking any prohibited medications
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
North Ryde, New South Wales 2109
AustraliaSite Not Available
Novartis Investigative Site
Randwick, New South Wales 2031
AustraliaSite Not Available
Novartis Investigative Site
North Ryde 7281782, New South Wales 2155400 2109
AustraliaSite Not Available
Novartis Investigative Site
Randwick 2208285, New South Wales 2155400 2031
AustraliaSite Not Available
Novartis Investigative Site
Herston, Queensland 4029
AustraliaSite Not Available
Novartis Investigative Site
Herston 6931014, Queensland 2152274 4029
AustraliaSite Not Available
Novartis Investigative Site
Cauldfield, Victoria 2145234 3162
AustraliaSite Not Available
Novartis Investigative Site
SouthPort, 4215
AustraliaSite Not Available
Novartis Investigative Site
Southport 2148928, 4215
AustraliaSite Not Available
Novartis Investigative Site
Leuven, 3000
BelgiumSite Not Available
Novartis Investigative Site
Leuven 2792482, 3000
BelgiumSite Not Available
Novartis Investigative Site
Liege, 4000
BelgiumSite Not Available
Novartis Investigative Site
Liège 2792413, 4000
BelgiumSite Not Available
Novartis Investigative Site
Calgary 5913490, Alberta 5883102 T2N 4N1
CanadaSite Not Available
Novartis Investigative Site
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Novartis Investigative Site
Hamilton 5969782, Ontario 6093943 L8N 3Z5
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H4A 3T2
CanadaSite Not Available
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H2X 0A9
CanadaSite Not Available
Novartis Investigative Site
Beijing, 100191
ChinaSite Not Available
Novartis Investigative Site
Beijing 1816670, 100191
ChinaSite Not Available
Novartis Investigative Site
Aalborg, 9000
DenmarkSite Not Available
Novartis Investigative Site
Aalborg 2624886, 9000
DenmarkSite Not Available
Novartis Investigative Site
Kobenhavn N V, 2400
DenmarkSite Not Available
Novartis Investigative Site
Turku 633679, 20521
FinlandSite Not Available
Novartis Investigative Site
Limoges 2998286, Haute Vienne 87000
FranceSite Not Available
Novartis Investigative Site
Bron 3029931, 69677
FranceSite Not Available
Novartis Investigative Site
Lille 2998324, 59037
FranceSite Not Available
Novartis Investigative Site
Montpellier 2992166, 34090
FranceSite Not Available
Novartis Investigative Site
Nice, 06001
FranceSite Not Available
Novartis Investigative Site
Nice 2990440, 06001
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75013
FranceSite Not Available
Novartis Investigative Site
Tours, 37044
FranceSite Not Available
Novartis Investigative Site
Tours 2972191, 37044
FranceSite Not Available
Novartis Investigative Site
Mannheim 2873891, Baden-Wurttemberg 2953481 68167
GermanySite Not Available
Novartis Investigative Site
Munich 2867714, Bavaria 2951839 81675
GermanySite Not Available
Novartis Investigative Site
Würzburg 2805615, Bavaria 2951839 97080
GermanySite Not Available
Novartis Investigative Site
Rostock 2844588, Mecklenburg-Vorpommern 2872567 18057
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13353
GermanySite Not Available
Novartis Investigative Site
Hanover 2910831, 30559
GermanySite Not Available
Novartis Investigative Site
Luebeck, 23538
GermanySite Not Available
Novartis Investigative Site
Lübeck 2875601, 23538
GermanySite Not Available
Novartis Investigative Site
Munchen, 81675
GermanySite Not Available
Novartis Investigative Site
Münster 2867543, 48149
GermanySite Not Available
Novartis Investigative Site
Ulm 2820256, 89081
GermanySite Not Available
Novartis Investigative Site
Dublin, DUBLIN 9
IrelandSite Not Available
Novartis Investigative Site
Dublin 2964574, DUBLIN 9
IrelandSite Not Available
Novartis Investigative Site
Milan 6951411, MI 20138
ItalySite Not Available
Novartis Investigative Site
Baggiovara 7870564, MO 41100
ItalySite Not Available
Novartis Investigative Site
Modena 3173331, MO 41126
ItalySite Not Available
Novartis Investigative Site
Pisa 3170647, PI 56126
ItalySite Not Available
Novartis Investigative Site
Torino 8980539, TO 10126
ItalySite Not Available
Novartis Investigative Site
Nagoya 1856057, Aichi-ken 1865694 466 8560
JapanSite Not Available
Novartis Investigative Site
Sendai city, Miyagi 980 8574
JapanSite Not Available
Novartis Investigative Site
Sendai 2111149, Miyagi 2111888 980 8574
JapanSite Not Available
Novartis Investigative Site
Ohtsu, Shiga 1852553 520-2192
JapanSite Not Available
Novartis Investigative Site
Tokushima 1850158, Tokushima 1850157 770-8503
JapanSite Not Available
Novartis Investigative Site
Ōta-ku 8469289, Tokyo 1850144 143 8541
JapanSite Not Available
Novartis Investigative Site
Yangsan Si, Gyeongsangnam Do 50612
Korea, Republic ofSite Not Available
Novartis Investigative Site
Seoul, 04763
Korea, Republic ofSite Not Available
Novartis Investigative Site
Utrecht, 3584
NetherlandsSite Not Available
Novartis Investigative Site
Utrecht 2745912, 3584 CX
NetherlandsSite Not Available
Novartis Investigative Site
Krakow 3094802, Poland 31 531
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz, 85-163
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz 3102014, 85-163
PolandSite Not Available
Novartis Investigative Site
Krakow, 30-721
PolandSite Not Available
Novartis Investigative Site
Warsaw 756135, 02-473
PolandSite Not Available
Novartis Investigative Site
Warszawa, 01-684
PolandSite Not Available
Novartis Investigative Site
Yangsan 1832828, Gyeongsangnam-do 1902028 50612
South KoreaSite Not Available
Novartis Investigative Site
Seoul 1835848, 05505
South KoreaSite Not Available
Novartis Investigative Site
L'Hospitalet de Llobregat 3120619, Barcelona 08907
SpainSite Not Available
Novartis Investigative Site
Donostia / San Sebastian 3110044, Basque Country 3336903 20080
SpainSite Not Available
Novartis Investigative Site
Barcelona 3128760, Catalonia 3336901 08003
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainSite Not Available
Novartis Investigative Site
Santiago 2511086, Corunja 15706
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28029
SpainSite Not Available
Novartis Investigative Site
Málaga 2514256, 29010
SpainSite Not Available
Novartis Investigative Site
Valencia 2509954, 46026
SpainSite Not Available
Novartis Investigative Site
Malmo, 214 28
SwedenSite Not Available
Novartis Investigative Site
Malmo 2692969, 214 28
SwedenSite Not Available
Novartis Investigative Site
Stockholm 2673730, 113 61
SwedenSite Not Available
Novartis Investigative Site
Umea, SE-90185
SwedenSite Not Available
Novartis Investigative Site
Umeå 602150, SE-90185
SwedenSite Not Available
Novartis Investigative Site
Basel, 4031
SwitzerlandSite Not Available
Novartis Investigative Site
Basel 2661604, 4031
SwitzerlandSite Not Available
Novartis Investigative Site
Sankt Gallen 2658822, 9007
SwitzerlandSite Not Available
Novartis Investigative Site
St Gallen, 9007
SwitzerlandSite Not Available
Novartis Investigative Site
Sheffield 2638077, South Yorkshire S10 2JF
United KingdomSite Not Available
Novartis Investigative Site
Farnborough 2649672, BR6 8ND
United KingdomSite Not Available
Novartis Investigative Site
London, WC1N 3BG
United KingdomSite Not Available
Novartis Investigative Site
London 2643743, SW17 0QT
United KingdomSite Not Available
Novartis Investigative Site
Stoke-on-Trent 2636841, ST4 6QG
United KingdomSite Not Available
University of California San Diego
La Jolla, California 92037
United StatesSite Not Available
Keck Medical Center USC
Los Angeles, California 90033
United StatesSite Not Available
UC San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
University of California San Diego
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
Loma Linda University Health
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
Keck Medical Center USC
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
UC San Francisco Medical Center
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Orlando Health Clinical Trials
Orlando, Florida 32806
United StatesSite Not Available
University of Miami
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Orlando Health Clinical Trials
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
University Of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University Of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Neurology Associates P C
Lincoln, Nebraska 68506-2960
United StatesSite Not Available
Neurology Associates P C
Lincoln 5072006, Nebraska 5073708 68506-2960
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesSite Not Available
Lange Neurology PC
New York, New York 10065
United StatesSite Not Available
Lange Neurology PC
New York 5128581, New York 5128638 10065
United StatesSite Not Available
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Atrium Health
Charlotte 4460243, North Carolina 4482348 28207
United StatesSite Not Available
Duke University Health System
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Univ of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Providence ALS Center
Portland 5746545, Oregon 5744337 97213
United StatesSite Not Available
Temple University
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
AMR Knoxville
Knoxville, Tennessee 37920
United StatesSite Not Available
AMR Knoxville
Knoxville 4634946, Tennessee 4662168 37920
United StatesSite Not Available
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesSite Not Available
Austin Neuromuscular Center
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Nerve and Muscle Center of Texas
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Washington Medical Center
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available

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