Daratumumab for Myalgic encephalomyelitis/Chronic fatigue syndrome

Inclusion criteria

• {"criterion_text":"- ME/CFS according to Canadian consensus criteria; moderate to severe disease\n- Age 18 to 65 years\n- Signed informed consent\n- At least two years disease duration\n- Defined onset of ME/CFS, e.g. after infection\n- Baseline Natural Killer (NK) cell count >130 x 10^6/L"}

Exclusion criteria

• {"criterion_text":"- Chronic fatigue conditions not fulfilling Canadian consensus criteria\n- Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection\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- Endogenous depression\n- Age under 18 or over 65 years\n- Mild or mild-moderate ME/CFS\n- Very severe ME/CFS\n- Participation in clinical intervention trial aimed at ME/CFS within two years before inclusion\n- Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab\n- Known contraindication to daratumumab\n- Significant comorbidity with reduced organ function (kidney, liver, heart, pulmonary)\n- Previous long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease"}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability as measured by treatment-emergent adverse events.","definition_or_measurement_approach":"Measured by treatment-emergent adverse events."}

Secondary endpoints

• {"endpoint_text":"- Changes in SF36 domain scores including Physical Function and Bodily pain, from the baseline/run-in period through 40 weeks' follow-up from start of intervention\n- Changes in DSQ-SF scores, from the baseline/run-in period through 40 weeks' follow-up from start of intervention\n- Changes in patient-reported physical function, from the baseline/run-in period through 40 weeks' follow-up from start of intervention\n- Changes in steps per 24 hours, from the baseline/run-in period through 40 weeks' follow-up from start of intervention","definition_or_measurement_approach":"Change from baseline through 40 weeks' follow-up; measured using SF-36 domain scores, DSQ-SF scores, patient-reported physical function measures, and step count per 24 hours."}

Norway

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

526

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway