Claseprubart in adults with generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional trial evaluating the efficacy, safety, and tolerability of claseprubart in adults with generalized MG. Participants undergo screening, a randomized blinded treatment period, and an optional extended treatment phase with open-label options, followed by a safety follow-up. The study compares claseprubart to placebo in a controlled setting, with additional extension periods for eligible participants to gather longer-term data. Eligibility includes confirmed gMG by antibody and functional criteria, MGFA class II-IVa, specific MG-ADL and QMG scores, vaccination status, and reproductive considerations. Locations include sites in Pasadena, CA; Boca Raton, FL; and Fayetteville, NC, led by Dianthus Therapeutics.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Study Site
  Pasadena, California, United States Recruiting
• Cinical Study Site
  Boca Raton, Florida, United States Recruiting
• Cinical Study Site
  Houston, Texas, United States Recruiting
• Cinical Study Site
  Kutaisi, Georgia Recruiting
• Clinical Study Site #2
  Tbilisi, Georgia Recruiting
• Clinical Study Site #3
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Dianthus Clinical Contact Center
• Email: clinicaltrials@dianthustx.com
• Phone: 929-999-4055

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study tests whether aritinercept is safe and helpful for adults with generalized myasthenia gravis compared with placebo.

  Recruiting at 11 sites Phase 1/2 Aurinia Pharmaceuticals Inc. · Pasadena, California and 10 other locations · NCT07596901

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• Corticosteroid-sparing efgartigimod for elderly AChR-positive generalized myasthenia gravis

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• Observational study on ravulizumab for generalized myasthenia gravis

  This study is looking at how well ravulizumab works for people with generalized myasthenia gravis over three years to see how it helps their health.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.