Helse Bergen HF (2025)
- Authors: Helse Bergen HF (Sponsor)
- Institutes: Helse Bergen HF
- Publisher: Clinicaltrials.eu
- Link: Clinicaltrials.eu
Summary
This ongoing randomized, double-blind, placebo-controlled clinical trial aims to determine if targeting specific immune cells can provide a breakthrough treatment for individuals suffering from moderate to severe ME/CFS. By comparing the effects of daratumumab 💊 to a placebo, the study seeks to confirm if this anti-CD38 antibody can significantly reduce the extreme fatigue and symptom burden that characterize the condition. For the patient community, this trial represents a rigorous effort to validate a potential therapeutic pathway that could substantially improve daily activity levels and overall quality of life.
What was researched?
The study evaluates the effectiveness of daratumumab 💊 in reducing the symptoms and improving the physical function of patients diagnosed with moderate to severe ME/CFS compared to those receiving a placebo.
Why was it researched?
ME/CFS is a debilitating condition with no standard approved treatment, and researchers aim to evaluate if daratumumab 💊 can help alleviate symptoms and improve the quality of life for those with moderate to severe forms of the disease. The drug as shown very promising results in a pilot study. Paper: Fluge et al. (2025)
How was it researched?
This clinical trial involves participants aged 18 to 64 who have had ME/CFS for at least two years and meet specific diagnostic criteria, including a minimum NK-cell level of 125 x10⁹/L. Participants are randomized to receive either daratumumab 💊 (combined with hyaluronidase) or a placebo via subcutaneous injection. The study includes a 26-week treatment phase and follow-up assessments through week 60, monitoring progress via symptom severity scores (DSQ-SF), physical function, and daily activity levels.
What has been found?
As a follow-up study that is currently ongoing, final results regarding the efficacy and overall response to treatment are not yet available. The study is designed to assess changes in symptoms and physical function compared to the baseline measurements taken at the start of the trial.
Discussion
The study is designed with strict eligibility criteria, excluding patients with psychiatric disorders, other serious medical conditions, or a history of cancer to ensure the clarity of the results. Safety and potential side effects are being continuously monitored throughout the trial period to ensure participant welfare.
Conclusion & Future Work
The final results of this study will contribute to the broader understanding of daratumumab’s 💊 role in treating ME/CFS and may provide a foundation for future therapeutic interventions for the condition.