Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

Part of paid clinical trials in Carlsbad, California.

Sponsor
NMD Pharma A/S
Study ID
NCT06414954
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myasthenia Gravis
  • Myasthenia Gravis, MuSK

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NMD670 — DRUG
    Tablets taken twice a day for 21 days
  • Placebo — DRUG
    Tablets taken twice a day for 21 days

Study Details

This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.

Key Dates

Start date
May 16, 2024
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NMD670 high dose
  • Experimental: NMD670 mid dose
  • Experimental: NMD670 low dose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline to day 21 in QMG total score for NMD670 vs placebo [ Time Frame: Baseline to day 21 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Profound Research LLCCarlsbadCalifornia92011-
University of California Irvine Medical CenterIrvineCalifornia92868
Siddhant Partap
[email protected]
650-224-2637
Ali Amer Habib (PRINCIPAL_INVESTIGATOR)
University of Colorado Neuromuscular DivisionAuroraColorado80045
Alexis Shepardson
[email protected]
303-724-4644
Stacy Dixon, MD (PRINCIPAL_INVESTIGATOR)
SFM Clinical Research, LLCBoca RatonFlorida33487
Gabrielle DeMaria
(561) 939-0333
Marc Feinberg, MD (PRINCIPAL_INVESTIGATOR)
Neuromuscular Research Division | University of South FloridaTampaFlorida33612
Jessica Shaw
[email protected]
813-974-9413
Tuan H Vu (PRINCIPAL_INVESTIGATOR)
Augusta University, Neuroscience CenterAugustaGeorgia30912
Brandy Quarles
[email protected]
706-721-0390
Michael Rivner (PRINCIPAL_INVESTIGATOR)
NextGen Precision HealthColumbiaMissouri65212
Neetha Gali
[email protected]
(573) 882-3065
David Arnold (PRINCIPAL_INVESTIGATOR)
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Manisha Chopra
[email protected]
1-919-843-7857
James Howard (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43221
Lischele Watkins,, MACPR
[email protected]
614-293-1737
University of OregonPortlandOregon97239
Katie Lewis
[email protected]
503-494-5236
Nizar Chahin (PRINCIPAL_INVESTIGATOR)
Semmes Murphey ClinicMemphisTennessee38120
Courtney Berryman
[email protected]
901-260-6111
Tulio Bertorini (PRINCIPAL_INVESTIGATOR)

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By research site
Profound Research LLC· Carlsbad, CAUniversity of California Irvine Medical Center· Irvine, CAUniversity of Colorado Neuromuscular Division· Aurora, COSFM Clinical Research, LLC· Boca Raton, FLNeuromuscular Research Division | University of South Florida· Tampa, FLAugusta University, Neuroscience Center· Augusta, GA

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