In short
Clinical trials are investigating HYALURONIDASE as part of a study in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The trial is looking at whether the study treatment can reduce symptoms and how the symptom score changes over time. It focuses on adults with moderate to severe ME/CFS.
Key points
- Clinical trials investigating HYALURONIDASE are being done in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The main trial listed is an authorized Phase 2 interventional study with 66 planned participants. It focuses on adults with moderate to severe ME/CFS and measures symptom change over time. The main endpoint is the DSQ-SF total score from baseline through follow-up until week 60. The trial is designed to see whether the study treatment can reduce ME/CFS symptoms.
Trial overview
One authorized clinical trial is studying HYALURONIDASE in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The trial is titled “Plasma cell targeting in ME/CFS” and is designed as an interventional study.
Study population
The trial is focused on people with moderate to severe ME/CFS. The source data do not give more detailed entry rules, but the study is clearly aimed at this patient group.
Study design and phase
This study is in Phase 2 and has a planned enrollment of 66 people. Phase 2 studies usually look more closely at whether a treatment may help and continue to collect study results in a defined patient group.
What the trial measures
The main outcome is the course of the DSQ-SF total score from baseline through follow-up until week 60. In simple terms, this means researchers are tracking how symptom scores change from the start of the study to later visits.
Treatment and comparison
The trial brief summary says the study is evaluating the efficacy of daratumumab versus placebo for reducing ME/CFS symptoms. HYALURONIDASE is listed as one of the study interventions, given by subcutaneous injection with the other study drug.
A placebo is a look-alike treatment used for comparison, so researchers can see whether the study treatment makes a real difference. The trial is therefore looking at symptom improvement over time in a controlled setting.