Table of Contents
- Trial overview
- Conditions and patient groups
- What the trials measure
- Trial phases and study designs
- Key Losmapimod trials
- What patients should know from the trial data
Trial overview
The source data includes three interventional studies of Losmapimod in people with facioscapulohumeral muscular dystrophy, often called FSHD.[1][2][3]
These studies are completed and include one Phase 3 trial and two Phase 2 trials.[1][2][3]
Conditions and patient groups
The main condition studied is facioscapulohumeral muscular dystrophy (FSHD), a muscle disease that causes weakness in the face, shoulder blades, and upper arms.[1]
Two studies focused on FSHD1, which is the subtype named in the trial records.[2][3]
The trials enrolled adults with these conditions, but the source data does not provide full eligibility rules such as age limits or medical exclusions.[1][2][3]
What the trials measure
The main goal in these studies is to check safety and tolerability, which means whether treatment causes problems and how well people can stay on it over time.[1][2][3]
Safety checks in the trial data include adverse events (AEs, meaning unwanted medical problems), clinical laboratory tests, ECGs, vital signs, and physical examinations.[1][2][3]
One Phase 3 study also measured change in muscle function over 48 weeks using a specific test called RSA Q1-Q5 with a 500 g wrist weight, averaged over both arms.[1]
That same study used this measure to assess disease progression, meaning whether the muscle disease got worse or changed over time.[1]
One Phase 2 study also mentions biomarker and clinical outcome assessments, which are tests that track signs of disease activity and patient results.[3]
Trial phases and study designs
Phase 2 studies are earlier trials that often look for safety and early signs of benefit.[2][3]
Phase 3 studies are larger trials that more fully test whether a treatment works and remains safe.[1]
All three studies are interventional, which means the researchers gave Losmapimod as the study treatment rather than only observing patients.[1][2][3]
The Phase 3 REACH study compared Losmapimod with a placebo, which is an inactive tablet that looks like the real treatment.[1]
Key Losmapimod trials
NCT05397470 was a Phase 3 study called REACH in 260 people with FSHD.[1]
This study looked at both efficacy, meaning how well the treatment works, and long-term safety and tolerability.[1]
Its main efficacy outcome was change from baseline in average total RSA Q1-Q5 with 500 g wrist weight at Week 48, averaged over both arms.[1]
Its safety outcome included adverse events, lab tests, ECGs, vital signs, and physical exams.[1]
2024-512732-30-00 was a Phase 2 open-label extension study in 80 people with FSHD1.[2]
An open-label extension means people continued treatment in a follow-up study where everyone knew what treatment was being used.[2]
The main endpoint was long-term safety and tolerability based on adverse events, lab tests, ECGs, vital signs, and physical examination.[2]
NCT04004000 was a Phase 2 study in 14 people with FSHD1.[3]
It focused on safety and tolerability during long-term dosing and also included biomarker and clinical outcome assessments.[3]
Its safety measures were adverse events, clinical laboratory tests, ECGs, and vital signs.[3]
What patients should know from the trial data
From the trial records, Losmapimod has been studied only in people with FSHD or FSHD1, not in a broad range of other conditions.[1][2][3]
The research focus is consistent across studies: check safety first, then look for signs that treatment may help muscle function or disease progression.[1][2][3]
Because the trials are completed, the source data describes past study results and design, not active recruitment.[1][2][3]
