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Abstract Details

Oral Cladribine Capsules for Generalized Myasthenia Gravis: Design of the Actively Recruiting Phase 3 MyClad Study
Neuromuscular and Clinical Neurophysiology (EMG)
P1 - Poster Session 1 (11:45 AM-12:45 PM)
11-013

To evaluate the efficacy and safety of a new oral formulation of cladribine versus placebo in generalized myasthenia gravis (gMG).
Myasthenia gravis (MG) is an autoantibody-mediated autoimmune disorder of neuromuscular junction transmission characterized by fluctuating muscle weakness, often beginning in ocular muscles and progressing to gMG. Cladribine is a B and T cell targeting immune reconstitution therapy designed to address the source of autoantibodies in gMG. Cladribine has shown efficacy in a pilot study of participants with gMG. We present the design of MyClad, an actively recruiting Phase 3 trial of a new oral formulation of cladribine in gMG (NCT06463587; funded by the healthcare business of Merck KGaA, Darmstadt, Germany).
MyClad is a 3-year Phase 3 trial that aims to recruit 240 participants with gMG (MG Foundation of America Class II–IVa). In the first double-blind, placebo-controlled period of 24 weeks, participants will be randomized in a 1:1:1 ratio to two short courses of placebo or one of two oral cladribine doses. In the following blinded extension period of 24 weeks, placebo recipients will be re-randomized to one of two oral cladribine doses. During this period and a third double-blind follow-up period of 96 weeks, any participant may be re-treated with oral cladribine if clinically needed. The primary endpoint is change from baseline to Week 24 in MG Activities of Daily Living scores for each oral cladribine dose versus placebo. Secondary endpoints include change from baseline to Week 24 in Quantitative MG, MG Composite, and MG 15-Item Quality of Life Scale-Revised scores; time from oral cladribine full dose to retreatment or rescue treatment; safety; and oral cladribine pharmacokinetics.

Not applicable.

MyClad is actively recruiting and seeks to establish meaningful clinical benefits with oral cladribine capsules in gMG by targeting B and T cell mediated autoimmunity.
Authors/Disclosures
Konrad Rejdak, PhD (Medical Univeristy of Lublin)
PRESENTER 		Dr. Rejdak has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck, Biogen, Bayer, Sanofi, Teva, Roche, Takeda. Dr. Rejdak has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck, Biogen, Bayer, Sanofi, Teva, Roche, Takeda.
James F. Howard, Jr., MD, FAAN (The University of North Carolina, Dept of Neurology, CB 7025) Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx . Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Regeneron Pharmaceuticals. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion Pharmaceuticals. Dr. Howard has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AMGEN (Horizon Therapeutics). Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven Ltd. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CorEvitas. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck EMD Serono. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cartesian Therapeutics. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NMD Pharma. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for H. Lundbeck A/S. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Seismic Therapeutics. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Dr. Howard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vor Biopharma. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Academic CME. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PeerView CME. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Platform Q CME. Dr. Howard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for MJH LifeSci. Dr. Howard has or had stock in Johnson & Johnson dividends.Dr. Howard has or had stock in Pfizer dividends. An immediate family member of Dr. Howard has or had stock in GlaxoSmithKline dividends.Dr. Howard has or had stock in Bristol Myer Squbb dividends.Dr. Howard has or had stock in AbbieVie Inc. The institution of Dr. Howard has received research support from Alexion Pharmaceuticals. The institution of Dr. Howard has received research support from argenx . The institution of Dr. Howard has received research support from UCB Biosciences. The institution of Dr. Howard has received research support from NIH. The institution of Dr. Howard has received research support from Centers for Disease Control/Research Triangle Institute. The institution of Dr. Howard has received research support from Cartestian Therapeutics. The institution of Dr. Howard has received research support from NMD Pharma. The institution of Dr. Howard has received research support from Ad Scientiam. The institution of Dr. Howard has received research support from Merck EMD Serono. Dr. Howard has a non-compensated relationship as a Scientific Advisiory Board member, Committee member with Myasthenia Gravis Foundation of America that is relevant to AAN interests or activities. Dr. Howard has a non-compensated relationship as a Committee member with American Assoc Neuromuscular and Electrodiagnostic Medicine that is relevant to AAN interests or activities.
Gary R. Cutter, PhD (University of Alabama At Birmingham) Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Kevin C. O'Connor, PhD (Yale University School of Medicine) Kevin C. O'Connor, PhD has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Immunovant. Kevin C. O'Connor, PhD has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Argenx. Kevin C. O'Connor, PhD has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurocrine. Kevin C. O'Connor, PhD has stock in Cabaletta. The institution of Kevin C. O'Connor, PhD has received research support from Seismic. The institution of Kevin C. O'Connor, PhD has received research support from Argenx. Kevin C. O'Connor, PhD has received intellectual property interests from a discovery or technology relating to health care.
Mazen M. Dimachkie, MD, FAAN (University of Kansas Medical Center) Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Octapharma. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ArgenX. Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for Catalyst. Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for Takeda. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medlink. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for Astellas. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dianthus. Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for TACT / Treat NMD. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cabaletta Bio. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Neurological Society of America, Inc . Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for Ig Society, Inc. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abcuro. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amicus. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon/Immunovant. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nuvig. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for 好色先生 (AAN). Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Annexon Biosciences. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AstraZeneca. Dr. Dimachkie has received personal compensation in the range of $0-$499 for serving as a Consultant for Candid Therapeutics. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Creyon Bio, Inc.. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nuvig Therapeutics. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB Biopharma. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vertex Pharmaceuticals. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Fortrea. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Kriya Therapeutics. The institution of Dr. Dimachkie has received research support from NIH. The institution of Dr. Dimachkie has received research support from The Myositis Association. The institution of Dr. Dimachkie has received research support from Biosensics. Dr. Dimachkie has received intellectual property interests from a discovery or technology relating to health care. Dr. Dimachkie has received intellectual property interests from a discovery or technology relating to health care. Dr. Dimachkie has received intellectual property interests from a discovery or technology relating to health care. Dr. Dimachkie has received publishing royalties from a publication relating to health care. Dr. Dimachkie has received publishing royalties from a publication relating to health care.
Jacqueline Palace (John Radcliff Hospital Oxford Univeristy Hospitals Trust) Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono, Medimmune, Argenx, Janssen, AMgen, UCB, Roche, Novartis, Amplo, Alexion, . Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx, Sanofi. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche, UCB, Alexion, Amgen. Dr. Palace has or had stock in Astra Zenica. The institution of Dr. Palace has received research support from Roche, AMPLO, Alexion, UCB,. argenx, amgen. Dr. Palace has received intellectual property interests from a discovery or technology relating to health care.
Andreas Meisel (Charité Universitätsmedizin Berlin) Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for argenx. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Adivo. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. The institution of Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Andreas Meisel has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for argenx. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer/BMS. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boehringer. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axunio. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Desitin. Andreas Meisel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genpharm. The institution of Andreas Meisel has received research support from Alexion. The institution of Andreas Meisel has received research support from argenx. The institution of Andreas Meisel has received research support from Octapharma. The institution of Andreas Meisel has received research support from Deutsche Myasthenie Gesellschaft. The institution of Andreas Meisel has received research support from Deutsche Forschungsgemeinschaft . The institution of Andreas Meisel has received research support from Bundesministerium für Wissenschaft und Forschung. The institution of Andreas Meisel has received research support from Leducq Foundation. The institution of Andreas Meisel has received research support from Einstein Stiftung Berlin. Andreas Meisel has received publishing royalties from a publication relating to health care. Andreas Meisel has received publishing royalties from a publication relating to health care. Andreas Meisel has a non-compensated relationship as a Chairman, Medical Advisory Board with Deutsche Myasthenie Gesellschaft that is relevant to AAN interests or activities. Andreas Meisel has a non-compensated relationship as a Chairman with Berliner Schlaganfall Gesellschaft that is relevant to AAN interests or activities.
Renato Mantegazza, MD Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Mantegazza has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. The institution of Dr. Mantegazza has received research support from ERAPERMED, EU.
Axel Nolting, MD Dr. Nolting has received personal compensation for serving as an employee of Merck Healthcare KGaA. Dr. Nolting has stock in Merck KGaA.
Sathej Gopalakrishnan, PhD Dr. Gopalakrishnan has received personal compensation for serving as an employee of Merck KGaA. An immediate family member of Dr. Gopalakrishnan has received personal compensation for serving as an employee of AbbVie Deutschland GmbH &Co KG. An immediate family member of Dr. Gopalakrishnan has received personal compensation for serving as an employee of Certara. An immediate family member of Dr. Gopalakrishnan has received personal compensation for serving as an employee of Merck KGaA. Dr. Gopalakrishnan has stock in Merck KGaA. An immediate family member of Dr. Gopalakrishnan has stock in AbbVie Deutschland GmbH & Co KG.
Claire Le Bolay, MD Mrs. Le Bolay has received personal compensation for serving as an employee of Merck Santé s.a.s. .
Andrija Javor Andrija Javor has received personal compensation for serving as an employee of Biogen. Andrija Javor has received stock or an ownership interest from Biogen.
Nektaria Alexandri Nektaria Alexandri has received personal compensation for serving as an employee of Merck Healthcare KGaA.
Dominic Jack (Merck Serono Ltd) Dominic Jack has received personal compensation for serving as an employee of Merck KGaA, Darmstadt, Germany.
Henry J. Kaminski, MD, FAAN (George Washington University) Dr. Kaminski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Kaminski has received personal compensation in the range of $0-$499 for serving as a Consultant for Cabaletta Bio. The institution of Dr. Kaminski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Kaminski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Canopy Immunotherapeutics. Dr. Kaminski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curie.bio. Dr. Kaminski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Kaminski has received personal compensation in the range of $0-$499 for serving as a Consultant for Care Constitution. Dr. Kaminski has stock in mimivax. The institution of Dr. Kaminski has received research support from National Institutes of Health. Dr. Kaminski has received publishing royalties from a publication relating to health care.