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New treatment option for Multifocal Motor Neuropathy
Official title A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy
ClinicalTrials.gov ID: NCT06537999
What this study is testing
What is Claseprubart?
Claseprubart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multifocal motor neuropathy.
Also referred to as DNTH103.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 (kg).
- Confirmed diagnosis of definite or probable MMN.
- Evidence of:
You likely can't join if
- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or...
- Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
- Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used...
- Currently or previously on complement inhibitors including in a clinical trial setting.
- Prior history (at any time) of N. meningitidis infection.
- Diagnosis of an autoimmune disorder other than MMN.
See the full eligibility criteria
- 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 (kg).
- Confirmed diagnosis of definite or probable MMN.
- Evidence of:
- Responsiveness to Ig treatment; and
- Receiving a stable Ig regimen
- Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
- 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...
- 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...
- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact how well it works assessments.
- Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
- 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...
- Currently or previously on complement inhibitors including in a clinical trial setting.
- Prior history (at any time) of N. meningitidis infection.
- Diagnosis of an autoimmune disorder other than MMN.
- 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.
- 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...
- 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).
- Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Bradenton, Florida, United States
- Tampa, Florida, United States
- Honolulu, Hawaii, United States
- Kansas City, Kansas, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Toronto, Canada
- Beijing, China
- Shanghai, China
- Aarhus, Denmark
- Copenhagen, Denmark
- Marseille, France
- Paris, France
- Rome, Italy
- Kota Kinabalu, Malaysia
- Kuala Lumpur, Malaysia
- Permatang Pauh, Malaysia
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Bradenton, Florida, United States; Tampa, Florida, United States; Honolulu, Hawaii, United States; Kansas City, Kansas, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.