Daratumumab for Myalgic encephalomyelitis | Chronic fatigue syndrome

Inclusion criteria

• {"criterion_text":"- ME/CFS according to Canadian consensus criteria; moderate (mainly housebound) to severe (partly bedridden) disease\n- Age 18 to 64 years\n- Signed informed consent\n- Duration of ME/CFS disease at least two years\n- A defined onset for ME/CFS, after an initial infection or other immunological trigger.\n- For women of childbearing potential (see protocol section 6.12.2): Negative serum pregnancy test.\n- 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).\n- NK-cell numbers at baseline must be ≥ 125 x109/L"}

Exclusion criteria

• {"criterion_text":"- Very severe ME/CFS, where the patient is unable to travel to the hospital for interventions and assessments\n- Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix.\n- Pregnancy or lactation.\n- Inability to comply with protocol including follow-up.\n- Participation in a clinical trial with drug intervention aimed at ME/CFS during the last three years.\n- Hypogammaglobulinemia (serum IgG < 5.0 g/L at baseline)\n- Endogenous depression.\n- Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab.\n- Known contraindication to daratumumab.\n- Significant comorbidity including reduced organ function (kidney, liver, heart, pulmonary, haematological).\n- Use of long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease.\n- Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection."}

Primary endpoints

• {"endpoint_text":"- The course of DSQ-SF total score from baseline through follow-up until week 60.","definition_or_measurement_approach":"Measured as the course (trajectory) of the DSQ-SF total score from baseline through follow-up until week 60."}

Secondary endpoints

• {"endpoint_text":"- The course of the modified DSQ-SF score from baseline (-12 to 0 weeks) until week 60.","definition_or_measurement_approach":"Measured as the course of the modified DSQ-SF score from baseline (-12 to 0 weeks) through week 60."}
• {"endpoint_text":"- The course of SF-36 Physical Function (SF-36 PF), FUNCAP total score and Steps per 24h (calculated as mean values per four-week interval), from baseline (-12 to 0 weeks) until week 60","definition_or_measurement_approach":"Measured as the course of SF-36 PF, FUNCAP total score and Steps per 24h (mean values per 4-week interval) from baseline (-12 to 0 weeks) to week 60."}
• {"endpoint_text":"- Overall response, defined as a decrease of 25 points in DSQ-SF score from baseline to the time interval 28 to 48 weeks after start of intervention","definition_or_measurement_approach":"Defined endpoint: overall response = decrease of 25 points in DSQ-SF score from baseline to 28–48 weeks after start of intervention."}
• {"endpoint_text":"- Steps per 24 hours, calculated as mean values per four-week interval, from baseline (-12 to 0 weeks) until week 60","definition_or_measurement_approach":"Measured as steps per 24 hours, reported as mean values per four-week interval from baseline (-12 to 0 weeks) until week 60."}
• {"endpoint_text":"- Safety and toxicity, recorded continuously through 60 weeks follow-up according to CTCAE ver. 5.0","definition_or_measurement_approach":"Safety and toxicity collected continuously through 60 weeks and graded according to CTCAE version 5.0."}

Norway

Earliest CTIS Part Ii Submission Date

25-04-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

308

Number Of Sites

2

Number Of Participants

66

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway