MOMENTUM

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults with Multifocal Motor Neuropathy (MOMENTUM)

• IRAS ID

  1010527

• Contact name

  Shruthi Giridhar

• Contact email

  sgiridhar@dianthustx.com

• Sponsor organisation

  Dianthus Therapeutics, Inc.

• Eudract number

  2024-513128-40

• Clinicaltrials.gov Identifier

  NCT06537999

• Research summary

  This global study is being conducted at hospitals, research centers and private medical clinics to test a biologic drug called DNTH103 in multifocal motor neuropathy (MMN). MMN is a rare, chronic autoimmune disease where the body’s immune system mistakenly attacks nerves, resulting in muscle weakness. The current standard of treatment for MMN is immunoglobulin, which can help with symptoms, but it is not effective in all patients and can become less effective over time. The main purpose of this study is to determine if DNTH103 is safe when given to adults with MMN and if it can improve the symptoms of MMN.
  The study involves three parts. Adults (ages 18-75 years) with a diagnosis of MMN who have been previously treated with immunoglobulins and meet all study criteria during the screening period will enter into Part 1 and be randomized (this is done by a computer) into one of 3 treatment arms and given either DNTH103 (low dose or high dose) or placebo (dummy medicine) over a 17-week period. The first dose of DNTH103 or placebo will be given as an infusion (slow injection into a vein) and then all other doses will be given as an injection under the skin every 2 weeks. Participants who complete Part 1 will have the option to enter into Part 2 where they will receive DNTH103 for up to a year. All participants will enter the Part 3 Safety Follow-Up, where no DNTH103 is given, which lasts 40 weeks. During the study, participants will be expected to go to the study clinic and have assessments completed. These assessments include blood tests, physical exams, review of health status and medications, and other tests and questionnaires that assess MMN status and quality of life.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  24/NW/0301

• Date of REC Opinion

  15 Nov 2024

• REC opinion

  Further Information Favourable Opinion