Open Norway: Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome, 2025

What is this study about?
This clinical trial is focused on studying the effects of a medication called daratumumab on patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS is a condition characterized by extreme fatigue that doesn’t improve with rest and can worsen with physical or mental activity. The medication being tested, daratumumab, is given as a subcutaneous injection, which means it is injected under the skin.

The purpose of this study is to evaluate the feasibility and safety of using daratumumab in patients with moderate to severe ME/CFS. The study will involve ten patients who will receive the medication over a period of time. Participants will be monitored for any side effects and changes in their condition. The study aims to gather information on how well patients tolerate the treatment and any potential benefits it may provide.

Throughout the study, researchers will track various aspects of the participants’ health, including physical function, bodily pain, and overall activity levels. This will help determine if daratumumab can be a safe and effective treatment option for those suffering from ME/CFS. The study is expected to continue for a set period, allowing researchers to collect comprehensive data on the medication’s impact on the disease.

1
initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to specific criteria, ensuring the disease is moderate to severe, and confirming the duration of the disease is at least two years.

The assessment also checks the age requirement (18 to 65 years) and ensures informed consent is signed.

2
baseline measurements
Baseline measurements are taken to establish a starting point for the study. These include assessments of physical function, bodily pain, and daily activity levels.

The SF36 and DSQ-SF scores are recorded, which are questionnaires used to evaluate health-related quality of life and symptom severity.

3
treatment phase
The treatment involves receiving subcutaneous injections of daratumumab, a medication known as DARZALEX 1800 mg solution for injection.

The injections are administered according to a schedule determined by the study protocol. The exact frequency and duration of administration are specified in the study guidelines.

4
monitoring and follow-up
Throughout the study, regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any adverse events that may occur.

Follow-up assessments are performed to evaluate changes in physical function, bodily pain, and daily activity levels over a period of 40 weeks from the start of the intervention.

5
end of study evaluation
At the conclusion of the study, a final evaluation is conducted to summarize the findings. This includes a comprehensive review of the safety and effectiveness of the treatment.

The results are compared to the baseline measurements to determine any significant changes in health status.


Who Can Join the Study?

• Have a condition called Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) that is moderate to severe. This means the illness is not mild and affects daily life significantly.
• Meet the Canadian consensus criteria for ME/CFS. This is a specific set of guidelines used to diagnose the condition.
• Be between the ages of 18 and 65 years old.
• Provide a signed informed consent. This means you agree to participate in the study after being informed about what it involves.
• Have had the disease for at least two years.
• Have a clear start to the illness, such as beginning after an infection.

Who Cannot Join the Study?

• Patients who have a known allergy or severe reaction to the study medication or any of its ingredients.
• Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
• Patients with a history of certain types of cancer, unless they have been in complete remission for at least 5 years.
• Patients with uncontrolled or severe heart problems, such as heart failure or recent heart attack.
• Patients with severe liver or kidney disease that is not well managed.
• Patients who are pregnant or breastfeeding.
• Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
• Patients who are unable to comply with the study procedures or follow-up visits.

Last updated: 17.04.2025 05:05

Trial ID: 2024-512500-19-00
Trial Phase: Therapeutic exploratory (Phase II)

https://clinicaltrials.eu/trial/stu...-moderate-to-severe-chronic-fatigue-syndrome/

 

Daratumumab Pilot Study discussed here:

https://www.s4me.info/threads/pilot-study-in-norway-daratumumab-in-me-cfs.28098/

 

No mention of blinding or placebo, and only ten pateints again? Disappointing imo.

 

They are using some objective outcomes in the current pilot and I assume they will do the same here, so blinding and placebo is not a complete must.

They know how to do blinded placebo trials, so I’m inclined to trust that they have a reason for not doing it.

 

I suppose so. I just want this drug tested thoroughly and as fast in terms of potentially getting it out to patients (if it works) as reasonably possible.

 

We all want a treatment as soon as possible, so I understand where you’re coming from. Fluge and Mella are nothing if not thorough. It is a hefty and potentially very dangerous drug, so they are not going to rush it.

 

That's entirely understandable. I wasn't expecting a phase 3 but this does look like a rehash of the pilot to me, rather than a step up.

 

My guess is that this is a formal Phase I safety study and may reflect a commitment from a drug company who want to do phase I by the book, looking forward to a development program. That would be disappointing for those who want to press on with an efficacy study (as I would) but it may be the route open.

 

Would that usually come with funding from the company? If so, it’s a massive thing.

 

I think this would only make sense if there’s some form of funding commitment and a complete roadmap from a pharmaceutical co? A Phase II trial could likely be funded by patients, patient organizations and already available funds. A Phase III however would be much more of a financial undertaking.

 

There is this on the study page:

Trial ID: 2024-512500-19-00
Trial Phase: Therapeutic exploratory (Phase II)

 

I assume or hope we will get some more data in the May meeting in Norway or the one in Germany. Which is why I am hoping someone we know will attend the first day (semi-closed) session of the Stavanger Norway meeting.

 

It would look like that, yes, but having been in this situation myself I know that pharmaceutical companies can oscillate in their level of interest and there is nothing very predictable about where things may go. Everything may change with a shift in head of unit.

But this looks like a repeat phase 1 or even revert to phase 1 after an independent pilot. They may well call it phase II though. These terms get shifted around largely for political reasons. Phase II can be used to apply to a trial that might give hints of efficacy but is basically safety or to formal proof of concept efficacy trials. My proof of concept large scale double blind randomised rituximab trial was called phase II.

I think what people are keen to get is a genuine proof of concept efficacy trial and that will cost $8M at minimum now is my guess. Fluge and Mella got a grant for their final ritux trial I think. Getting grants for drug trial sis hard because grant bodies say Pharma should pay.

I don't pretend to know what is going on but this looks like a step sideways for some pragmatic reason relating to what options are available.

 

Sasha reminds me that I expressed safety concerns over B cell drugs in the context of the pandemic. It may be that someone has decided that more safety data are needed before going ahead with a large scale trial.

 

My 2 cents: recruitment is not going to be an issue because Bergen (the city where Haukeland is located) is relatively large and Fluge and Mella are well known. I’m also assuming they already have plans for most of the infrastructure.

 

This bit interests me. Does anyone know why they would require this? I wonder what percentage of people are aware of a clear start. For me, I think it's likely there was an infectious start but it was progressive so hard to pinpoint exact start.

 

I assume it's to not burden severe patients with being in the control arm as a phase 1 study. They'll probably have controls if the results are worth it.

 

Maybe as part of their measures to try and ensure participants have the same illness?

The fact that ME/CFS could be several different conditions is a major challenge.

 

I wonder if they intend to do home visits? That would drastically increase the cost and logistics, especially depending on the samples they need.

 

This sort of thing always concerns me a little bit, its denying a reality of the disease and none of the widespread criteria says it must be an infection onset, nor should it as it would exclude a decent minority of patients who can't point to that. Something about this makes me feel like they have a particular ideology about the cause and that those people are a sub group that are different, but without the research to show that is the case I don't see think its justified. In my opinion you have to do the work to show there are separate groups correlated with onset type before its reasonable to start splitting the groups up.