Clinical trial · Observational
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
NCT07294170CI-TRIAL-00123275recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AChR-Ab Seropositive Generalized Myasthenia Gravis | — | UNRESOLVED | — |
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
| Generalized Myasthenia Gravis (gMG) | — | UNRESOLVED | — |
| gMG | — | UNRESOLVED | — |
| MG | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efgartigimod IV | Biological | — | UNRESOLVED |
| Efgartigimod PH20 SC PFS | Biological | — | UNRESOLVED |
| Empasiprubart IV | Biological | — | UNRESOLVED |
| Placebo IV | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ISA1 participants
- description
- Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
- interventionNames
- Biological: Efgartigimod IV
- Biological: Empasiprubart IV
- label
- ISA2 participants
- description
- Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
- interventionNames
- Biological: Empasiprubart IV
- Other: Placebo IV
- Biological: Efgartigimod PH20 SC PFS
Primary outcomes (1)
- measure
- To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
- timeFrame
- Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment * If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening Exclusion Criteria: * Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk * Is MGFA (Myasthenia Gravis Foundation of America) Class V
References
Publications (0)
Data not yet available
No reference posted for this study.