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Taking people in NorwayPhase 2

Tests daratumumab for symptoms of ME/CFS in adults

Tests daratumumab, compared with placebo, in adults with moderate to severe ME/CFS.

Key facts

Who runs it
Helse Bergen HF
Where
Bergen and Oslo, NorwaySee the 2 sites
Registry title
Plasma cell targeting in ME/CFS
Status
Recruiting
Phase
Phase 2
People taking part
66 people, planned
Started
11 Jun 2025
Expected to end
31 Dec 2030
Type of study
Interventional
Record updated
17 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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 Norway

  • Helse Bergen HFBergen, NorwayTaking people
  • Oslo University Hospital HFOslo, NorwayTaking people

About the trial

What the trial wants to find out

To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests daratumumab for symptoms of ME/CFS in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2024-520094-13-00, who can take part
Record updated
17 July 2026