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Clinical Trials in the UK / NCT06537999
Active, not recruiting Phase 2

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

NCT06537999 · tracked via the Priya Life Science UK tracker
Sponsor
Dianthus Therapeutics
Phase
Phase 2
Started
2024-09-17
Last updated
2026-08-10

Condition(s) studied

Multifocal Motor Neuropathy

Investigational drug(s) / intervention(s)

ClaseprubartPlacebo

Claseprubart: * Day 1: IV loading dose * Week 1 to Week 15: Claseprubart administered SC every 2 weeks

Placebo: * Day 1: IV infusion of placebo * Week 1 to Week 15: placebo administered SC every 2 weeks

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Adult males and females, 18 to 75 years of age (inclusive). 3. Weight range between 40 to 120 kilograms (kg). 4. Confirmed diagnosis of definite or probable MMN. 5. Evidence of: 1. Responsiveness to Ig treatment; and 2. Receiving a stable Ig regimen 6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability. 7. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception. 8. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening. Exclusion Criteria: 1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments. 2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy). 3. Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization. 4. Currently or previously on complement inhibitors including in a clinical trial setting. 5. Prior history (at any time) of N. meningitidis infection. 6. Diagnosis of an autoimmune disorder other than MMN. 7. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening. 8. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone. 9. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1). 10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes. 11. Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Clinical Study Site Scottsdale Arizona
Clinical Study Site Los Angeles California
Clinical Study Site Bradenton Florida
Clinical Study Site Tampa Florida
Clinical Study Site Honolulu Hawaii
Clinical Study Site Kansas City Kansas
Clinical Study Site Cincinnati Ohio
Clinical Study Site Columbus Ohio
Clinical Study Site Houston Texas
Cinical Study Site Toronto Canada
Cinical Study Site Beijing China
Clinical Study Site Beijing China
Cinical Study Site Shanghai China
Clinical Study Site Aarhus Denmark
Clinical Study Site Copenhagen Denmark
Clinical Study Site Marseille France
Clinical Study Site Paris France
Clinical Study Site Rome Italy
Clinical Study Site Kota Kinabalu Malaysia
Cinical Study Site Kuala Lumpur Malaysia
Cinical Study Site Kuala Lumpur Malaysia
Cinical Study Site Permatang Pauh Malaysia
Cinical Study Site Sarawak Malaysia
Clinical Study Site Amsterdam Netherlands
Clinical Study Site Utrecht Netherlands
Clinical Study Site Skopje North Macedonia
Clinical Study Site Bydgoszcz Poland
Clinical Study Site Katowice Poland
Clinical Study Site Krakow Poland
Clinical Study Site Krakow Poland
Clinical Study Site Belgrade Serbia
Cinical Study Site Daegu South Korea
Cinical Study Site #2 Seoul South Korea
Clinical Study Site Seoul South Korea
Cinical Study Site Alicante Spain
Clinical Study Site Barcelona Spain
Cinical Study Site Barcelona Spain
Cinical Study Site Istanbul Turkey (Türkiye)
Clinical Study Site London England
Clinical Study Site Oxford England

+ 1 more sites — see the full list on the official registry below.

More Dianthus Therapeutics trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06537999 on ClinicalTrials.gov ↗ ← All trials in the UK