Plasma cell targeting in ME/CFS

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Immune System Diseases [C20]

Trial duration

11 Jun 2025 → ongoing

Decision date (initial)

2025-05-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bjørn Rune Gjelsten (private donation) · The ME Network in Norway · The Norwegian ME Association · ME-morene · Careless by Sara Emilie Tandberg · The legacy of Torstein Hereid · Fokus på ME

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To evaluate the efficacy of daratumumab vs placebo on reducing ME/CFS symptoms in subjects with moderate to severe ME/CFS.

Secondary objectives 2

1. To evaluate the efficacy of daratumumab vs placebo on reducing core ME/CSF symptoms and improving physical function and activity level.
2. To evaluate the safety and toxicity of daratumumab vs placebo in subjects with moderate to severe ME/CFS.

Conditions and MedDRA coding

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Regulatory references

Plan to share IPD

Yes

IPD plan description

Deidentified individual participant data collected during the trial will be shared after end of study.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. ME/CFS according to Canadian consensus criteria; moderate (mainly housebound) to severe (partly bedridden) disease
2. Age 18 to 64 years
3. Signed informed consent
4. Duration of ME/CFS disease at least two years
5. A defined onset for ME/CFS, after an initial infection or other immunological trigger.
6. For women of childbearing potential (see protocol section 6.12.2): Negative serum pregnancy test.
7. 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).
8. NK-cell numbers at baseline must be ≥ 125 x109/L

Exclusion criteria 12

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The course of DSQ-SF total score from baseline through follow-up until week 60.

Secondary endpoints 5

1. The course of the modified DSQ-SF score from baseline (-12 to 0 weeks) until week 60.
2. 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
3. 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
4. Steps per 24 hours, calculated as mean values per four-week interval, from baseline (-12 to 0 weeks) until week 60
5. Safety and toxicity, recorded continuously through 60 weeks follow-up according to CTCAE ver. 5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Øystein Fluge

Public contact point

Organisation

Helse Bergen HF

Contact name

Øystein Fluge

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications