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)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) — Baseline to Week 17 Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Trial sites (41)
Facility
City
Region
Status
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.
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.
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