New drug aims to ease daily struggles of myasthenia gravis
NCT ID NCT07647510
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times
Summary
This phase 3 trial tests whether claseprubart (DNTH103) can improve symptoms of generalized myasthenia gravis, a condition causing muscle weakness. About 195 adults with a specific antibody type are randomly assigned to receive the drug or a placebo. The main goal is to see if the drug helps with daily activities and muscle strength over 17 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- claseprubart (DNTH103)
- What this could lead to
- If successful, this could provide a new treatment option for people with generalized myasthenia gravis, potentially improving their ability to perform daily activities and muscle strength.
- What could go wrong
- This is a phase 3 trial, but results may not confirm benefit or could show side effects. The drug is still investigational and not yet approved.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 195 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Sep 2031
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 80 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 Hide 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. Weight range between 40-130 kg at Screening 3. Diagnosis of gMG by the following tests: 1. Acetylcholine receptor antibody (AChR Ab) positive, and 2. One of the following: i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors. 4. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa 5. MG-ADL scale score of 6 or more 6. QMG scale score of 10 or more 7. Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability 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 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 Exclusion Criteria: 1. History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures 2. Known complement deficiency 3. Prior history (at any time) of N. meningitidis infection 4. Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening 5. Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. \[ 6. Any thymic surgery/biopsy within 1 year of Screening 7. Any known or untreated thymoma. 8. Any history of thymic carcinoma or thymic malignancy 9. 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 10. Concurrent or previous use of the following medication within the time periods specified below. 1. Rituximab or other B-cell targeting therapies (ie, inebilizumab) 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) 11. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent 12. Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Myasthenia gravis, generalized are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cinical Study Site
RECRUITINGBoca Raton, Florida, 33432, United States
-
Cinical Study Site
NOT_YET_RECRUITINGFayetteville, North Carolina, 28304, United States
-
Cinical Study Site
RECRUITINGHouston, Texas, 77009, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered immune cells take aim at myasthenia gravis
- Can tracking daily life unlock myasthenia gravis mysteries?
- Miniature Nerve-Muscle models may reveal why some myasthenia gravis patients Don't improve
- Engineered immune cells take on rare Muscle-Weakening disease
- New drug aritinercept aims to tame myasthenia gravis symptoms
- New drug trial aims to tame muscle weakness in myasthenia gravis