A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

Dianthus Therapeutics3 sites in 2 countries65 target enrollmentFebruary 23, 2024

ConditionsMyasthenia Gravis, Generalized

InterventionsPlacebo DNTH103

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Myasthenia Gravis, Generalized
Sponsor: Dianthus Therapeutics
Enrollment: 65
Locations: 3
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Status: Active, Not Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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).

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 (52 weeks) * Safety follow-up (40 weeks)

Registry

clinicaltrials.gov

Start Date

February 23, 2024

End Date

August 1, 2027

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dianthus Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•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
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

Placebo

Intervention: Placebo

DNTH103 low dose Q2W

Intervention: DNTH103

DNTH103 high dose Q2W

Intervention: DNTH103

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score(Baseline (Day 1) to Week 13)
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score(Baseline (Day 1) to Week 13)
Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score(Baseline (Day 1) to Week 13)
Incidence of TEAEs and Treatment-Emergent SAEs(Baseline (Day 1) up to Week 52 of the OLE)
Serum Concentrations of DNTH103(Baseline (Day 1) to Week 52 of the OLE)
Change from Baseline in Complement Total Blood Test (CH50)(Baseline (Day 1) to Week 52 of the OLE)
Incidence and Titer of Antidrug Antibody (ADAs) Against DNTH103(Baseline (Day 1) to Week 52 of the OLE)