Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06537999

A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy

Led by Dianthus Therapeutics · Updated on 2026-04-30

36

Participants Needed

26

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of Claseprubart (DNTH103) in participants with multifocal motor neuropathy (MMN).

CONDITIONS

Official Title

A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have given written informed consent before any study-related activities are carried out
  • Adult males and females, 18 to 75 years of age (inclusive)
  • Weight range between 40 to 120 kilograms
  • Confirmed diagnosis of definite or probable MMN
  • Evidence of responsiveness to Ig treatment and receiving a stable Ig regimen
  • Documented vaccinations against encapsulated bacteria as required locally
  • Female participants must be of nonchildbearing potential or agree to use highly effective contraception if of childbearing potential
  • Male participants must agree not to donate sperm and use acceptable contraception or be surgically sterile for at least 90 days before screening
Not Eligible

You will not qualify if you...

  • History or presence of significant medical or surgical conditions including acute illness or major surgery that could impact efficacy assessments
  • Conditions interfering with outcome assessments such as severe diabetic neuropathy
  • Current or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine within 6 months prior to randomization
  • Current or previous use of complement inhibitors including in clinical trials
  • Prior history of N. meningitidis infection
  • Diagnosis of autoimmune disorders other than MMN
  • Positive tests for active HIV-1, HIV-2, hepatitis B surface antigen, or hepatitis C virus antibodies during screening
  • History of active malignancy within 5 years prior to screening except certain treated skin and cervical cancers or low-grade prostate adenocarcinoma under observation
  • Participation in another investigational drug study within 90 days or 5 half-lives before randomization
  • Any other overlapping condition or mental illness that could affect study assessments or participant compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Clinical Study Site

Scottsdale, Arizona, United States, 85251

Actively Recruiting

2

Clinical Study Site

Los Angeles, California, United States, 90048

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3

Clinical Study Site

Bradenton, Florida, United States, 34205

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4

Clinical Study Site

Tampa, Florida, United States, 33620

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5

Clinical Study Site

Honolulu, Hawaii, United States, 96817

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6

Clinical Study Site

Kansas City, Kansas, United States, 66103

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7

Clinical Study Site

Chapel Hill, North Carolina, United States, 27599

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8

Clinical Study Site

Cincinnati, Ohio, United States, 45219

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9

Clinical Study Site

Columbus, Ohio, United States, 43210

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10

Clinical Study Site

Houston, Texas, United States, 77030

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11

Clinical Study Site

Aarhus, Denmark, 8200

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12

Clinical Study Site

Copenhagen, Denmark, 1172

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13

Clinical Study Site

Marseille, France, 13005

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14

Clinical Study Site

Paris, France, 94000

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15

Clinical Study Site

Rome, Italy, 00189

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16

Clinical Study Site

Amsterdam, Netherlands, 1105

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17

Clinical Study Site

Utrecht, Netherlands

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18

Clinical Study Site

Skopje, North Macedonia

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19

Clinical Study Site

Bydgoszcz, Poland, 85-090

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20

Clinical Study Site

Katowice, Poland, 40-689

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21

Clinical Study Site

Krakow, Poland, 30-688

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22

Clinical Study Site

Krakow, Poland, 31-202

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23

Clinical Study Site

Belgrade, Serbia, 11000

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24

Clinical Study Site

Barcelona, Spain, 08035

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25

Clinical Study Site

London, England, United Kingdom

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26

Clinical Study Site

Oxford, England, United Kingdom

Actively Recruiting

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Research Team

D

Dianthus Clinical Contact Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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