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New treatment option for Myasthenia Gravis, Generalized
Official title A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
ClinicalTrials.gov ID: NCT07647510
What this study is testing
What is Claseprubart?
Claseprubart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis, generalized.
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 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 80
You may be able to join if
- Must have given written informed consent before any study-related activities are carried out
- Weight range between 40-130 kg at Screening
- 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...
You likely can't join if
- History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be...
- Known complement deficiency
- Prior history (at any time) of N. meningitidis infection
- Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2)...
- Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
- Any thymic surgery/biopsy within 1 year of Screening
See the full eligibility criteria
- Must have given written informed consent before any study-related activities are carried out
- Weight range between 40-130 kg at Screening
- 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.
- Myasthenia Gravis Foundation of America (MGFA) Class II-IVa
- MG-ADL scale score of 6 or more
- QMG scale score of 10 or more
- Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability
- 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...
- 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
- 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/how well...
- Known complement deficiency
- Prior history (at any time) of N. meningitidis infection
- 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...
- Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
- Any thymic surgery/biopsy within 1 year of Screening
- Any known or untreated thymoma.
- Any history of thymic carcinoma or thymic malignancy
- 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...
- Concurrent or previous use of the following medication within the time periods specified below.
- Rituximab or other B-cell targeting therapies (ie, inebilizumab) within 6 months (180 days) prior to randomization (Day 1);
- Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1)
- Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent
- Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, North Carolina, United States
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, North Carolina, United States. 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.