Myasthenia Gravis, GeneralizedPhase 2MAGICNCT06282159
A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
A Phase 2 study testing Claseprubart in people with Myasthenia Gravis, Generalized, run by Dianthus Therapeutics at 56 sites in 14 countries.
Trial summary
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 65 participants
- Where
- 56 sitesin 14 countries
- Study dates
- 23 Feb 2024to Oct 2028
- Phase
- Phase 2
- 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 75 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.
- Adult males and females, 18 to 75 years of age (inclusive) at Screening.
- Weight range between 40-120 kg at Screening.
- Diagnosis of gMG by the following tests:
- Acetylcholine receptor antibody (AChR Ab) positive, and
- One of the following:
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- 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
- Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
- 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.
- 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 must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
Who cannot join
- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
- Prior history (at any time) of N. meningitidis infection.
- 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.
- Any thymic surgery/biopsy within 1 year of Screening.
- Any known or untreated thymoma.
- Any history of thymic carcinoma or thymic malignancy.
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- Concurrent or previous use of the following medication within the time periods specified below.
- Rituximab 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.
Trial locations and contacts
56 sites in 14 countries.
56 sites in 14 countries
United States21 sites
Clinical Study Site
Boca Raton, Florida, 33487
Clinical Study Site
Boston, Massachusetts, 02215
Clinical Study Site
Bradenton, Florida, 34205
Clinical Study Site
Cincinnati, Ohio, 45219
Clinical Study Site
Columbia, Missouri, 65212
Clinical Study Site
Columbus, Ohio, 43221
Clinical Study Site
Dallas, Texas, 75206
Clinical Study Site
Dallas, Texas, 75243
Clinical Study Site
East Lansing, Michigan, 48824
Clinical Study Site #2
Houston, Texas, 77030
Clinical Study Site
Houston, Texas, 77030
Clinical Study Site
Irvine, California, 92868
Clinical Study Site
Kansas City, Kansas, 66103
Clinical Study Site
Lexington, Kentucky, 40503
Clinical Study Site
Lubbock, Texas, 79414
Clinical Study Site
Maitland, Florida, 32751
Clinical Study Site
O'Fallon, Illinois, 62269
Clinical Study Site
Phoenix, Arizona, 85028
Clinical Study Site
Richmond, Virginia, 23219
Clinical Study Site
Stamford, Connecticut, 06905
Clincal Study Site
Tampa, Florida, 33620
Poland7 sites
Clinical Study Site
Bydgoszcz, 85-065
Clinical Study Site
Katowice, 40123
Clinical Study Site
Krakow, 31-202
Clinical Study Site
Krakow, 31-503
Clinical Study Site
Lublin, 20-093
Clinical Study Site
Warsaw, 01-684
Clinical Study Site
Warsaw, 02-657
Argentina6 sites
Clinical Study Site
Buenos Aires, 20/11/1902
Clinical Study Site
Buenos Aires, C1012AAR
Clinical Study Site
Buenos Aires, C1015ABR
Clinical Study Site
Córdoba, X5004CDT
Clinical Study Site
Rosario, 2000
Clinical Study Site
San Miguel de Tucumán, Tucumán Province, T4000
Italy5 sites
Clinical Study Site
Milan, 20133
Clinical Study Site
Naples, 80131
Clinical Study Site
Pisa, 56126
Clinical Study Site
Rome, 00168
Clinical Study Site
Rome, 00189
Serbia4 sites
Clinical Study Site
Belgrade, 11000
Clinical Study Site
Kragujevac, 34000
Clinical Study Site
Niš, 18000
Clinical Study Site
Novi Sad, 21000
France3 sites
Clinical Study Site
Bordeaux, 33076
Clinical Study Site
Nice, 06001
Clinical Study Site
Strasbourg, 67000
Israel3 sites
Clinical Study Site
Haifa, 3109601
Clinical Study Site
Ramat Gan
Clinical Study Site
Safed, 13100
About this study
Official title: A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
Read the detailed description
The study includes the following periods:
- Screening (up to 10 weeks)
- Randomized, blinded, controlled treatment (RCT) period (13 weeks)
- Open-label extension (OLE) period (optional) for eligible participants (104 weeks)
- Safety follow-up (SFU) (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
Day 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks
PlaceboDrug
Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Claseprubart 300 mg Q2W | Experimental | Not described Receives: Drug: Claseprubart |
| Claseprubart 600 mg Q2W | Experimental | Not described Receives: Drug: Claseprubart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Measured: Baseline (Day 1) to Week 13
Secondary outcomes (7)
Change from Baseline 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 13
Change from Baseline 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 13
Change from Baseline to Week 13 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 13
Incidence of TEAEs and Treatment-Emergent SAEs
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Measured: Through OLE completion, an average of 117 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 end of SFU, for a maximum of 197 weeks
Change from Baseline in Complement Total Blood Test (CH50)
Blood samples will be collected to determine changes in CH50 at various timepoints.
Measured: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Incidence and Titer of Antidrug Antibody (ADAs) Against Claseprubart
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Measured: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Feb 2024
- Primary completion28 Jul 2025
- Study completionOct 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dianthus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282159
- Sponsor's protocol ID
- DNTH103-MG-201
- Other IDs
- 2024-512865-15-00
- Acronym
- MAGIC
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
- ClinicalTrials.gov ID
- NCT06282159
- Acronym / sponsor ID
- MAGIC / DNTH103-MG-201
- Conditions
- Myasthenia Gravis, Generalized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dianthus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 28 Feb 2024 (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 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
Detailed description
The study includes the following periods:
- Screening (up to 10 weeks)
- Randomized, blinded, controlled treatment (RCT) period (13 weeks)
- Open-label extension (OLE) period (optional) for eligible participants (104 weeks)
- Safety follow-up (SFU) (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 |
| Claseprubart 300 mg Q2W | Experimental | Drug: Claseprubart |
| Claseprubart 600 mg Q2W | Experimental | Drug: Claseprubart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have given written informed consent before any study-related activities are carried out.
- Adult males and females, 18 to 75 years of age (inclusive) at Screening.
- Weight range between 40-120 kg at Screening.
- Diagnosis of gMG by the following tests:
- Acetylcholine receptor antibody (AChR Ab) positive, and
Key exclusion criteria (10 listed)
- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
- Prior history (at any time) of N. meningitidis infection.
- 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.
- Any thymic surgery/biopsy within 1 year of Screening.
- Any known or untreated thymoma.
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: DNTH103Day 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks | Drug | Claseprubart 300 mg Q2W, Claseprubart 600 mg Q2W |
| PlaceboDay 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Baseline (Day 1) to Week 13
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
7 secondary outcomes
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Time frame: Baseline (Day 1) to Week 13
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score
Time frame: Baseline (Day 1) to Week 13
Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score
Time frame: Baseline (Day 1) to Week 13
Incidence of TEAEs and Treatment-Emergent SAEs
Time frame: Through OLE completion, an average of 117 weeks
Serum Concentrations of Claseprubart
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Change from Baseline in Complement Total Blood Test (CH50)
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Incidence and Titer of Antidrug Antibody (ADAs) Against Claseprubart
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 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 27 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Claseprubart in people with Myasthenia Gravis, Generalized, run by Dianthus Therapeutics at 56 sites in 14 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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Poland, Argentina, Italy, Serbia and 9 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) (time frame: Baseline (Day 1) to Week 13). 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 27 Jul 2026.