Myasthenia Gravis, GeneralizedPhase 3NCT07647510
A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
A Phase 3 study testing Claseprubart in people with Myasthenia Gravis, Generalized, run by Dianthus Therapeutics at 12 sites in 3 countries.
Trial summary
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- Claseprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 29 Jun 2026to Sep 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
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- 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, must agree to use a highly effective method of contraception
- 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
Who cannot join
- 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
- 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 vaccination) or hepatitis C virus (HCV) during Screening
- Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
- Any thymic surgery/biopsy within 1 year of Screening
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- 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 low-grade prostate adenocarcinoma for which appropriate management is observation alone
- 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
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
Georgia6 sites, 6 recruiting
- Recruiting
Cinical Study Site
Kutaisi
- Recruiting
Clinical Study Site #2
Tbilisi
- Recruiting
Clinical Study Site #3
Tbilisi
- Recruiting
Clinical Study Site #4
Tbilisi
- Recruiting
Clinical Study Site #5
Tbilisi
- Recruiting
Clinical Study Site
Tbilisi
United States4 sites, 4 recruiting
- Recruiting
Cinical Study Site
Boca Raton, Florida, 33432
- Not yet recruiting
Cinical Study Site
Fayetteville, North Carolina, 28304
- Recruiting
Cinical Study Site
Houston, Texas, 77009
- Recruiting
Clinical Study Site
Pasadena, California, 91106
Ukraine2 sites, 2 recruiting
- Recruiting
Cinical Study Site
Dnipro
- Recruiting
Cinical Study Site
Vinnytsia
About this study
Official title: A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
Read the detailed description
The study includes the following periods:
- Screening (up to 12 weeks)
- Randomized, blinded, controlled treatment (RCT) period (17 weeks)
- Extended treatment period (ETP) (104 weeks) (optional) for eligible participants [includes blinded extension period (BEP) and open-label extension (OLE) period]
- Safety Follow-Up period (40 weeks)
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- Claseprubart, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClaseprubartDrug
Also called DNTH103
IV loading dose on Day 1
PlaceboDrug
IV infusion on Day 1
ClaseprubartCombination product
Prefilled syringe containing claseprubart for SC administration
PlaceboCombination product
Prefilled syringe containing placebo for SC administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8). Receives: Drug: Placebo; Combination Product: Placebo |
| Claseprubart Q2W | Experimental | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8). Receives: Drug: Claseprubart; Combination Product: Claseprubart |
| Claseprubart Every 4 weeks (Q4W) | Experimental | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo. Receives: Drug: Claseprubart; Combination Product: Claseprubart; Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Measured: Baseline (Day 1) to Week 17
Secondary outcomes (10)
Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score
The QMG is a clinician-reported assessment to evaluate muscle strength. The QMG consists of 13 items that measure endurance or fatiguability, with each item having a possible score that ranges from 0 - 3. The total possible QMG scores range from 0 - 39, with a higher score indicating greater disease burden.
Measured: Baseline (Day 1) to Week 17
Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score
The MGC is a validated assessment tool for measuring clinical status of participants with MG. The range of total MGC score is 0 to 50, with higher scores indicating more severe disease. A clinically meaningful improvement is reflected by a 3-point improvement in MGC score. The MGC assesses 10 important functional areas most frequently affected by MG and the scales are weighted for clinical significance that incorporates patient-reported outcomes.
Measured: Baseline (Day 1) to Week 17
Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline
Measured: Baseline (Day 1) to Week 17
Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy
Measured: Baseline (Day 1) to Week 17
Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline
Measured: Baseline (Day 1) to Week 17
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Measured: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Serum Concentrations of Claseprubart
Blood samples will be collected for measurement of serum concentrations of claseprubart at various timepoints both pre- and post-dose.
Measured: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo
Blood samples will be collected to determine changes in CH50 at various timepoints.
Measured: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Measured: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Measured: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start29 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dianthus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647510
- Sponsor's protocol ID
- DNTH103-MG-301
- Other IDs
- 2026-525298-38-00
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)
- ClinicalTrials.gov ID
- NCT07647510
- Acronym / sponsor ID
- DNTH103-MG-301
- Conditions
- Myasthenia Gravis, Generalized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Dianthus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
Detailed description
The study includes the following periods:
- Screening (up to 12 weeks)
- Randomized, blinded, controlled treatment (RCT) period (17 weeks)
- Extended treatment period (ETP) (104 weeks) (optional) for eligible participants [includes blinded extension period (BEP) and open-label extension (OLE) period]
- Safety Follow-Up period (40 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Combination Product: PlaceboIntravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8). |
| Claseprubart Q2W | Experimental | Drug: Claseprubart, Combination Product: ClaseprubartIV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8). |
| Claseprubart Every 4 weeks (Q4W) | Experimental | Drug: Claseprubart, Combination Product: Claseprubart, Combination Product: PlaceboIV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Myasthenia Gravis Foundation of America (MGFA) Class II-IVa
- MG-ADL scale score of 6 or more
Key exclusion criteria (14 listed)
- 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
- 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 vaccination) or hepatitis C virus (HCV) during Screening
- Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClaseprubartAlso: DNTH103IV loading dose on Day 1 | Drug | Claseprubart Every 4 weeks (Q4W), Claseprubart Q2W |
| PlaceboIV infusion on Day 1 | Drug | Placebo |
| ClaseprubartPrefilled syringe containing claseprubart for SC administration | Combination product | Claseprubart Every 4 weeks (Q4W), Claseprubart Q2W |
| PlaceboPrefilled syringe containing placebo for SC administration | Combination product | Claseprubart Every 4 weeks (Q4W), Placebo |
Primary outcome
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Time frame: Baseline (Day 1) to Week 17
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
10 secondary outcomes
Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score
Time frame: Baseline (Day 1) to Week 17
Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score
Time frame: Baseline (Day 1) to Week 17
Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline
Time frame: Baseline (Day 1) to Week 17
Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy
Time frame: Baseline (Day 1) to Week 17
Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline
Time frame: Baseline (Day 1) to Week 17
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up
Time frame: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Serum Concentrations of Claseprubart
Time frame: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo
Time frame: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Time frame: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Time frame: Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Claseprubart in people with Myasthenia Gravis, Generalized, run by Dianthus Therapeutics at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Georgia, United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dianthus Clinical Contact Center (929-999-4055, clinicaltrials@dianthustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score (time frame: Baseline (Day 1) to Week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.