Plasma cell targeting 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, NorvégiaTaking people
- Oslo University Hospital HFOslo, NorvégiaTaking people
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 2024-520094-13-00
- Record updated
- 2026. július 17.
- Original description
To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.Read full original descriptionShow less
Plasma cell targeting using the anti-CD38 antibody daratumumab in patients with Myalgic Encephalomyelitis (ME/CFS) – a randomized, placebo-controlled and double-blind phase II study
To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.
Inclusion: ME/CFS according to Canadian consensus criteria; moderate (mainly housebound) to severe (partly bedridden) disease; Age 18 to 64 years; Signed informed consent; Duration of ME/CFS disease at least two years; A defined onset for ME/CFS, after an initial infection or other immunological trigger; For women of childbearing potential (see protocol section 6.12.2): Negative serum pregnancy test; Women of childbearing potential must use highly effective contraception for at least four weeks before start of treatment and at least 24 weeks following the administration of the last injection (see section 6.12.2); NK-cell numbers at baseline must be ≥ 125 x109/L.
Exclusion: Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix; Participation in a clinical trial with drug intervention aimed at ME/CFS during the last three years; Use of long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease; Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab; Significant comorbidity including reduced organ function (kidney, liver, heart, pulmonary, haematological); Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection; Hypogammaglobulinemia (serum IgG < 5.0 g/L at baseline); Very severe ME/CFS, where the patient is unable to travel to the hospital for interventions and assessments; Pregnancy or lactation; Inability to comply with protocol including follow-up; Endogenous depression; Known contraindication to daratumumab.