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New drug could reduce need for infusions in nerve disorder

NCT ID NCT06537999

Disease control Sponsor: Dianthus Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a drug called claseprubart (DNTH103) in 36 adults with multifocal motor neuropathy, a rare nerve condition that causes muscle weakness. Participants receive either the drug or a placebo for 15 weeks. The study looks at safety, how the drug works in the body, and whether it can delay the need for standard immunoglobulin therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Claseprubart (also called DNTH103)
What this could lead to
If it works, this could point toward a new treatment option for multifocal motor neuropathy that reduces the need for immunoglobulin therapy.
What could go wrong
This is an early Phase 2 trial with only 36 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.
Why investors are watching

Dianthus Therapeutics is running a small Phase 2 trial of its drug Claseprubart in 46 adults with multifocal motor neuropathy, a rare nerve condition. For a micro-cap company with few other products, this readout will likely be a major driver of its value, as it tests whether the drug safely controls the disease better than a placebo.

If it works: If the trial shows Claseprubart is safe and effective, Dianthus could have a promising treatment for a rare disease with few options. That result might attract partners or funding to advance the drug into later-stage testing.

If it fails: The trial could fail to show a clear benefit over placebo, or safety problems could emerge, which is common in drug development. For a company this small, a negative or delayed result could sharply reduce its prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multifocal motor neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multifocal motor neuropathy

Contacts and locations

Locations

  • Cinical Study Site

    Toronto, Canada

  • Cinical Study Site

    Beijing, 100053, China

  • Cinical Study Site

    Shanghai, 200031, China

  • Cinical Study Site

    Kuala Lumpur, 50586, Malaysia

  • Cinical Study Site

    Kuala Lumpur, 59100, Malaysia

  • Cinical Study Site

    Permatang Pauh, 13700, Malaysia

  • Cinical Study Site

    Sarawak, 93586, Malaysia

  • Cinical Study Site

    Daegu, South Korea

  • Cinical Study Site

    Alicante, 03010, Spain

  • Cinical Study Site

    Barcelona, 08041, Spain

  • Cinical Study Site

    Istanbul, 34093, Turkey (Türkiye)

  • Cinical Study Site #2

    Seoul, South Korea

  • Clinical Study Site

    Scottsdale, Arizona, 85251, United States

  • Clinical Study Site

    Los Angeles, California, 90048, United States

  • Clinical Study Site

    Bradenton, Florida, 34205, United States

  • Clinical Study Site

    Tampa, Florida, 33620, United States

  • Clinical Study Site

    Honolulu, Hawaii, 96817, United States

  • Clinical Study Site

    Kansas City, Kansas, 66103, United States

  • Clinical Study Site

    Cincinnati, Ohio, 45219, United States

  • Clinical Study Site

    Columbus, Ohio, 43210, United States

  • Clinical Study Site

    Houston, Texas, 77030, United States

  • Clinical Study Site

    Beijing, 100730, China

  • Clinical Study Site

    Aarhus, 8200, Denmark

  • Clinical Study Site

    Copenhagen, 1172, Denmark

  • Clinical Study Site

    Marseille, 13005, France

  • Clinical Study Site

    Paris, 94000, France

  • Clinical Study Site

    Rome, 00189, Italy

  • Clinical Study Site

    Kota Kinabalu, 88200, Malaysia

  • Clinical Study Site

    Amsterdam, 1105, Netherlands

  • Clinical Study Site

    Utrecht, Netherlands

  • Clinical Study Site

    Skopje, North Macedonia

  • Clinical Study Site

    Bydgoszcz, 85-090, Poland

  • Clinical Study Site

    Katowice, 40-689, Poland

  • Clinical Study Site

    Krakow, 30-688, Poland

  • Clinical Study Site

    Krakow, 31-202, Poland

  • Clinical Study Site

    Belgrade, 11000, Serbia

  • Clinical Study Site

    Seoul, South Korea

  • Clinical Study Site

    Barcelona, 08035, Spain

  • Clinical Study Site

    London, England, United Kingdom

  • Clinical Study Site

    Oxford, England, United Kingdom

  • Clinical Study Site

    Salford, England, United Kingdom

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