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New drug DNTH103 aims to tame muscle weakness in myasthenia gravis

NCT ID NCT06282159

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This Phase 2 study tests a drug called DNTH103 (claseprubart) in 65 adults with generalized myasthenia gravis, a condition that causes muscle weakness. Participants receive either the drug or a placebo, first through an IV and then as injections under the skin every two weeks for 11 weeks. The goal is to see if the drug is safe and can improve daily activities like talking, swallowing, and moving.

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), a drug given by IV and then injections under the skin
What this could lead to
If it works, this could point toward a new treatment option to control symptoms of generalized myasthenia gravis.
What could go wrong
This is an early Phase 2 trial with only 65 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

65 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Oct 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) at Screening. 3. Weight range between 40-120 kg at Screening. 4. Diagnosis of gMG by the following tests: Acetylcholine receptor antibody (AChR Ab) positive, and One of the following: i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors. 5. Myasthenia Gravis Foundation of America (MGFA) Class II-Iva 6. Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more 7. Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug. 8. Female participants must: Be of non-childbearing 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. 9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm Exclusion Criteria: 1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant 2. Prior history (at any time) of N. meningitidis infection. 3. 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. 4. Any thymic surgery/biopsy within 1 year of Screening. 5. Any known or untreated thymoma. 6. Any history of thymic carcinoma or thymic malignancy. 7. Concurrent or previous use of the following medication within the time periods specified below. 1. Rituximab within 6 months (180 days) prior to randomization (Day 1); 2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1). 8. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

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

Myasthenia gravis, generalized

Contacts and locations

Locations

  • Clincal Study Site

    Tampa, Florida, 33620, United States

  • Clinical Study Site

    Haifa, 3109601, Israel

  • Clinical Study Site

    Ramat Gan, Israel

  • Clinical Study Site

    Safed, 13100, Israel

  • Clinical Study Site

    Milan, 20133, Italy

  • Clinical Study Site

    Naples, 80131, Italy

  • Clinical Study Site

    Pisa, 56126, Italy

  • Clinical Study Site

    Rome, 00168, Italy

  • Clinical Study Site

    Rome, 00189, Italy

  • Clinical Study Site

    Amsterdam, Netherlands

  • Clinical Study Site

    Skopje, 1000, North Macedonia

  • Clinical Study Site

    Bergen, 5021, Norway

  • Clinical Study Site

    Bydgoszcz, 85-065, Poland

  • Clinical Study Site

    Katowice, 40123, Poland

  • Clinical Study Site

    Krakow, 31-202, Poland

  • Clinical Study Site

    Krakow, 31-503, Poland

  • Clinical Study Site

    Lublin, 20-093, Poland

  • Clinical Study Site

    Warsaw, 01-684, Poland

  • Clinical Study Site

    Warsaw, 02-657, Poland

  • Clinical Study Site

    Belgrade, 11000, Serbia

  • Clinical Study Site

    Kragujevac, 34000, Serbia

  • Clinical Study Site

    Niš, 18000, Serbia

  • Clinical Study Site

    Novi Sad, 21000, Serbia

  • Clinical Study Site

    Malmö, Sweden

  • Clinical Study Site

    Phoenix, Arizona, 85028, United States

  • Clinical Study Site

    Irvine, California, 92868, United States

  • Clinical Study Site

    Stamford, Connecticut, 06905, United States

  • Clinical Study Site

    Boca Raton, Florida, 33487, United States

  • Clinical Study Site

    Bradenton, Florida, 34205, United States

  • Clinical Study Site

    Maitland, Florida, 32751, United States

  • Clinical Study Site

    O'Fallon, Illinois, 62269, United States

  • Clinical Study Site

    Kansas City, Kansas, 66103, United States

  • Clinical Study Site

    Lexington, Kentucky, 40503, United States

  • Clinical Study Site

    Boston, Massachusetts, 02215, United States

  • Clinical Study Site

    East Lansing, Michigan, 48824, United States

  • Clinical Study Site

    Columbia, Missouri, 65212, United States

  • Clinical Study Site

    Cincinnati, Ohio, 45219, United States

  • Clinical Study Site

    Columbus, Ohio, 43221, United States

  • Clinical Study Site

    Dallas, Texas, 75206, United States

  • Clinical Study Site

    Dallas, Texas, 75243, United States

  • Clinical Study Site

    Houston, Texas, 77030, United States

  • Clinical Study Site

    Lubbock, Texas, 79414, United States

  • Clinical Study Site

    Richmond, Virginia, 23219, United States

  • Clinical Study Site

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Clinical Study Site

    Buenos Aires, 20/11/1902, Argentina

  • Clinical Study Site

    Buenos Aires, C1012AAR, Argentina

  • Clinical Study Site

    Buenos Aires, C1015ABR, Argentina

  • Clinical Study Site

    Córdoba, X5004CDT, Argentina

  • Clinical Study Site

    Rosario, 2000, Argentina

  • Clinical Study Site

    London, Ontario, N6A 5W9, Canada

  • Clinical Study Site

    Ostrava, 70852, Czechia

  • Clinical Study Site

    Copenhagen, 02100, Denmark

  • Clinical Study Site

    Bordeaux, 33076, France

  • Clinical Study Site

    Nice, 06001, France

  • Clinical Study Site

    Strasbourg, 67000, France

  • Clinical Study Site #2

    Houston, Texas, 77030, United States

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