A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

26 Feb 2025 → ongoing

Decision date (initial)

2024-09-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Celgene Corporation

External identifiers

EU CT number

2022-501332-42-00

WHO UTN

U1111-1281-5433

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Pharmacodynamic, Efficacy, Safety

To test if ozanimod is effective compared to fingolimod (a different medication that can treat RRMS)

Secondary objectives 4

1. Core phase: To determine efficacy, safety, and tolerability of ozanimod
2. Core phase: To measure the amount of ozanimod and certain substances in the participant’s body.
3. Extension Phase: To determine efficacy, effectiveness, safety, and tolerability of ozanimod.
4. Extension phase: To measure the amount of ozanimod and certain substances in the participant’s body.

Conditions and MedDRA coding

Relapsing Remitting Multiple Sclerosis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001710-PIP02-14

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Core Phase: Diagnosis of MS with a RRMS
2. Core Phase: 1 MS relapse in the previous year or 2 MS relapse in past 2 years or evidence of 1 or more growth in MRI within 6 months
3. Core Phase: 0 - 5.5 Expanded Disability Status Scale (EDSS)
4. Core Phase: Must be able to swallow capsule
5. Extension Phase: Completion of core phase

Exclusion criteria 7

1. Core and Extension phase: Diagnosis of progressive form of MS
2. Core and Extension Phase: Active or chronic disease of the immune system
3. Core and Extension Phase: Any cardiovascular, liver, neurological, endocrine, or other major body disease or history or presence of malignancy
4. Core and Extension Phase: History of any type of epileptic seizures, substance abuse, progressive neurological disorder, or history of suicide attempt
5. Core and Extension Phase: Pregnant or breastfeeding females
6. Core and Extension Phase: Previous treatment with certain lymphocyte-depleting therapies or other immunosuppressants
7. Core and Extension Phase: Discontinued treatment with fingolimod or similar modulator, due to the medication not working

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Core phase: To assess rate of Multiple Sclerosis (MS) relapse over 2 years

Secondary endpoints 4

1. Core and Extension Phase: proportion of the participants who have worsening or improving RRMS
2. Core and Extension Phase: occurrence of adverse events (type, severity and relationship to the study drug)
3. Core and Extension Phase: early study discontinuation
4. Core and Extension Phase: measurements of the amount of ozanimod in a participant’s body

Investigational products

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

Test 4

Comparator 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 6

Locations

5 EU/EEA countries · 15 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 54 files

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

Application history

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