2024-512500-19-00Active, not recruitingPhase 2
Daratumumab in ME/CFS
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Nov 2025
Brief summary (registry, in English)
To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Jun 2024
- Start date
- 29 Apr 2022
- Lead sponsor
- Helse Bergen HF
- Diseases
- Long COVID and ME/CFS
- EU CT number
- 2024-512500-19-00
- EudraCT number
- 2022-000281-18
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Age under 18 or over 65 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helse Bergen HF | Bergen | Norway | Active, not recruiting |
| Oslo Universitetssykehus HF | Oslo | Norway | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.