2024-520094-13-00RecruitingPhase 2
Plasma cell targeting in ME/CFS
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jul 2026
Brief summary (registry, in English)
To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 11 Jun 2025
- Lead sponsor
- Helse Bergen HF
- Diseases
- Long COVID and ME/CFS
- EU CT number
- 2024-520094-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- 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.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 64 with moderate to severe ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) to test daratumumab against a placebo.
- Age
- 18 to 64 years
- Sex
- All sexes
- Disease stage
- ME/CFS by the Canadian consensus criteria, moderate (mainly housebound) to severe (partly bedridden). The illness must have lasted at least two years and started after an infection or other immune trigger.
- Earlier treatment
- No drug trial aimed at ME/CFS in the last three years. No long-term immunosuppressant treatment in the last two years, apart from short steroid courses.
- Biomarker or test result
- NK-cell numbers at baseline must be ≥ 125 x109/L. Serum IgG must not be below 5.0 g/L.
Main reasons for not taking part
- Very severe ME/CFS, unable to travel to the hospital
- Pregnancy or breastfeeding
- Past or current cancer, except basal skin carcinoma or carcinoma in situ of the cervix
- Known allergy risk or contraindication to daratumumab
- Chronic infections such as hepatitis B or C or HIV
Read by machine on 9 Nov 2026.
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.
- 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.
Other illness
- 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.
Lab values
- Hypogammaglobulinemia (serum IgG < 5.0 g/L at baseline)
Other
- 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.
Who the study is looking for
- 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
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 | Recruiting |
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.