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Plasma cell targeting in ME/CFS
EU CTIS ID: 2024-520094-13-00
What this study is testing
To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Very severe ME/CFS, where the patient is unable to travel to the hospital for interventions and assessments
- Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix.
- Pregnancy or lactation.
- Inability to comply with protocol including follow-up.
- Participation in a clinical trial with drug intervention aimed at ME/CFS during the last three years.
- Hypogammaglobulinemia (serum IgG < 5.0 g/L at baseline)
See the full eligibility criteria
- 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
- Very severe ME/CFS, where the patient is unable to travel to the hospital for interventions and assessments
- Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix.
- Pregnancy or lactation.
- Inability to comply with protocol including follow-up.
- Participation in a clinical trial with drug intervention aimed at ME/CFS during the last three years.
- Hypogammaglobulinemia (serum IgG < 5.0 g/L at baseline)
- Endogenous depression.
- Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab.
- Known contraindication to daratumumab.
- Significant comorbidity including reduced organ function (kidney, liver, heart, pulmonary, haematological).
- Use of long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease.
- Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.