Effects of CLADribine tablets on the Immune Synapse, in Relapsing Multiple Sclerosis (RMS) patients_CLADIS.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aristotle University Of Thessaloniki

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck KGaA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary endpoint is to assess changes in the immune synapse molecules in naive MS patients treated with cladribine tablets compared to healthy volunteers, at 12-months of treatment.

Secondary objectives 7

1. to assess changes in the immune synapse molecules in naive MS patients treated with cladribine tablets compared to healthy volunteers, at 6-months of treatment
2. to assess changes in the disease activity in terms of relapses in naive MS patients treated with cladribine tablets
3. to assess changes in the disease - related disability in naive MS patients treated with cladribine tablets
4. to assess changes in the disease radiological activity in naive MS patients treated with cladribine tablets
5. to assess changes in the disease activity in naive MS patients treated with cladribine tablets
6. to assess the association of the expression of Immune Synapse molecules with clinical outcomes
7. to assess the association of the expression of Immune Synapse molecules with MRI outcomes

Conditions and MedDRA coding

Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with RRMS, age ≥18 and ≤50 years old
2. Treatment naive
3. Cladribine prescription per the decision of the treating physician and according to the approved MAVENCLAD SmPC in Greece
4. Absence of other neurological disease
5. Willingness / ability to provide written informed consent
6. Full diagnostic workup for MS in the previous 6 months prior to the inclusion to the study

Exclusion criteria 7

1. Contraindications to use of cladribine tablets according to the Summary of Product Characteristics
2. Patients with history of alcohol or drug abuse that could potentially interfere with their participation in the study
3. Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol
4. Age <18 or >50
5. Evidence of progressive MS
6. Prior or current use of other DMT
7. MS diagnosis >6 months prior to the inclusion to the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 12- months of treatment, relative to baseline

Secondary endpoints 12

1. Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 6- months of treatment, relative to baseline
2. Change in the ARR at year 1, relative to the 12-month pre-treatment period
3. Change in EDSS at the end of year 1, compared to baseline
4. Change in T25FW at the end of year 1, compared to baseline
5. Change in 9HPT at the end of year 1, compared to baseline
6. Number of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline
7. Number of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline
8. Number CUA at the end of year 1, compared to baseline
9. Proportion of patients with NEDA-3 at the end of year 1
10. Proportion of patients with MEDA-3 at the end of year 1
11. Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with clinical outcomes at the end of year 1
12. Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with MRI outcomes at the end of year 1

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aristotle University Of Thessaloniki

Sponsor organisation

Aristotle University Of Thessaloniki

Address

P. O. Box 404

City

Thessaloniki

Postcode

541 24

Country

Greece

Scientific contact point

Organisation

Aristotle University Of Thessaloniki

Contact name

Nikolaos Grigoriadis

Public contact point

Organisation

Aristotle University Of Thessaloniki

Contact name

Nikolaos Grigoriadis

Third parties 1

Locations

1 EU/EEA country · 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 12 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