Daratumumab in ME/CFS
Key facts
- Where
- Bergen és Oslo, NorvégiaSee the 2 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Norvégia
- Helse Bergen HFBergen, NorvégiaNo longer taking part
- Oslo Universitetssykehus HFOslo, NorvégiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Helse Bergen HF
- Trial code
- EU 2024-512500-19-00
- Record updated
- 2025. november 12.
- Original description
To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.Read full original descriptionShow less
A pilot study using subcutaneous injections of the anti-CD38 antibody daratumumab in patients with moderate to severe Myalgic Encephalomyelitis /Chronic Fatigue Syndrome (ME/CFS)
To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.
Inclusion: ME/CFS according to Canadian consensus criteria; moderate to severe disease; Age 18 to 65 years; Signed informed consent; At least two years disease duration; Defined onset of ME/CFS, e.g. after infection; Baseline Natural Killer (NK) cell count >130 x 10^6/L.
Exclusion: Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix; Previous long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease; Chronic fatigue conditions not fulfilling Canadian consensus criteria; Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection; Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab; Significant comorbidity with reduced organ function (kidney, liver, heart, pulmonary); Age under 18 or over 65 years; Pregnancy or lactation; Inability to comply with protocol including follow-up; Endogenous depression; Mild or mild-moderate ME/CFS; Very severe ME/CFS; Participation in clinical intervention trial aimed at ME/CFS within two years before inclusion; Known contraindication to daratumumab.