A controlled phase II clinical trial evaluating the safety and efficacy of myelin peptide-loaded tolDC as treatment for Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Antwerp University Hospital

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

completed 6 Nov 2025

Decision date (initial)

2024-11-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

FWO TBM

External identifiers

EU CT number

2024-512891-37-00

EudraCT number

2022-003465-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Conduct a phase II clinical trial to assess the efficacy and safety of administrating myelin-derived peptide-pulsed tolDC, generated using Good Manufacturing Practice (GMP), in patients with Relapsing Remitting and Progressive MS.

Secondary objectives 4

1. Proportion of relapse-free patients
2. Changes in relapse rate (compared with the year before inclusion)
3. Changes from baseline in mean EDSS scores and supplementary ambulatory clinical outcome measures (9HPT, T25FW and SDMT)
4. Change from baseline in T2 lesion volume, atrophy rate, total brain volume and fractional anisotropy (from diffusion tensor imaging, DTI) on MRI scans

Conditions and MedDRA coding

Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. MS according to most recent Mc Donald’s diagnostic criteria
2. Age 18-60 years
3. Expanded disability status scale (EDSS) of 0-6.0 inclusive
4. Active MS (relapsing and progressive): 1 relapse in the past year and/or at least 1 enhancing lesion on brain MRI in the past year and/or at least 1 new or enlarging T2 lesion in comparison with a reference scan from maximum 1 year before
5. MS patients on first-line treatment (control arm) or untreated patients (no wish to be treated with currently available disease-modifying treatments or presence of treatment- related side effects; intervention arms)
6. No evidence of relapse in the month prior to start of screening and throughout the screening phase
7. Normal total lymphocyte count
8. Normal peripheral B cell count
9. Able to sign informed consent
10. Ability to comply with the protocol assessments
11. Appropriate venous access
12. Use of adequate contraceptive measures during the duration of the trial. Women and men of reproductive potential can only be included in the study following use of adequate contraceptive measures. Accepted methods of contraception include use of hormonal contraceptives (oral, intravaginal, intrauterine, or transdermal), intrauterine devices, sterilization or postmenopausal status, use of condoms with spermicide

Exclusion criteria 20

1. Previous use of severe immunosuppressive or cytostatic treatment, including cyclophosphamide, mitoxantrone, bone marrow transplantation or (hematopoietic or mesenchymal) stem cell transplantation (at any time) prior to enrolment
2. Previous use of cladribine with last course within last 2 years or alemtuzumab with last course within last 4 years; lymphocyte counts should be above 800/mm3
3. Use of interferon beta and glatiramer acetate in the 4 previous weeks; use of teriflunomide in the previous 4 weeks with accelerated elimination procedure; use of dimethyl/diroximel fumarate in the previous 4 weeks with normal lymphocyte counts (above 800/mm3)
4. Treatment with fingolimod, siponimod, ponesimod, ozanimod, natalizumab, immunoglobulins or plasmapheresis in the past 3 months; teriflunomide in the previous 15 weeks without accelerated elimination; anti-CD20 monoclonal antibody (including ofatumumab, rituximab and ocrelizumab) within the past 6 months prior to the first administration and until confirmation of B cell count normalization; for S1P modulators lymphocyte counts should be above 800/mm3
5. Use of another investigational product in the past 6 months or longer depending on the mode of action
6. Previous use of azathioprine or methotrexate in the past 3 months
7. Previous use of other immunosuppressive agents washout is at least 3 months or longer depending on the mode of action and half-life
8. Relapse / use of corticosteroids for any reason in the previous month
9. Pregnancy or planning pregnancy in the next 18 months and breast feeding;
10. Fertile patients, both men and women, who are not using an adequate method of contraception. If the patient is menopausal or sterile, it must be documented in the medical history
11. Drug or alcohol abuse
12. Inability to undergo MRI assessments
13. History of or actual signs of immunodeficiency or malignancies
14. History of oncological diseases unless local basal cell carcinoma
15. Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease
16. Hepatitis B or C, HIV serology, syphilis or tuberculosis
17. Splenectomy
18. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol
19. Participating in another interventional clinical trial, assessing an IMP, or having participated in one, in the last 6 months
20. Previous treatment in the phase I clinical trial with tolDC

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans

Secondary endpoints 5

1. The number and severity of adverse events
2. Proportion of relapse-free patients
3. Changes in relapse rate (compared with the year before inclusions)
4. Changes from baseline in mean EDDS scores and supplementary ambulatory clinical outcome measures
5. change from baseline in T1 Gd and T2 lesion load, atrophy, and total brain volume on MRI scans

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antwerp University Hospital

Sponsor organisation

Antwerp University Hospital

Address

Drie Eikenstraat 655

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

Antwerp University Hospital

Contact name

Amber Dams

Public contact point

Organisation

Antwerp University Hospital

Contact name

Amber Dams

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

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

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