Daratumumab in ME/CFS

Phase 1

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
MedDRA version: 26.1Level: LLTClassification code: 10028414Term: Myalgic encephalomyelitis Class: 10021881
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2024-512500-19-00

Lead Sponsor: Helse Bergen HF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

ME/CFS according to Canadian consensus criteria; moderate to severe disease, Age 18 to 65 years, Signed informed consent, At least two years disease duration, Defined onset of ME/CFS, e.g. after infection

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.;Secondary Objective: Efficacy, measured by changes in secondary end points;Primary end point(s): Safety and tolerability as measured by treatment-emergent adverse events.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):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;Secondary end point(s):Changes in DSQ-SF scores, from the baseline/run-in period through 40 weeks' follow-up from start of intervention;Secondary end point(s):Changes in patient-reported physical function, from the baseline/run-in period through 40 weeks' follow-up from start of intervention;Secondary end point(s):Changes in steps per 24 hours, from the baseline/run-in period through 40 weeks' follow-up from start of intervention