Comparative PK, PD, efficacy, safety and immunogenicity assessment of the proposed ocrelizumab biosimilar CYB704 and Ocrevus in participants with relapsing multiple sclerosis (STRIVE-MS)

Start 1 Jul 2025 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 22 sites · Protocol CCYB704A12301

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 200

Countries 3

Sites 22

Subjects with relapsing multiple sclerosis (relapsing remitting MS or active secondary progressive MS)

Key facts

Sponsor: H e x a l AG
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trial duration: 1 Jul 2025 → ongoing
Decision date (initial): 2025-06-02
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-512319-40-00
WHO UTN: U1111-1317-7023
ClinicalTrials.gov: NCT06847724

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Subjects with relapsing multiple sclerosis (relapsing remitting MS or active secondary progressive MS)

Version	Level	Code	Term	System organ class
20.0	PT	10048393	Multiple sclerosis relapse	100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

H e x a l AG

Sponsor organisation: H e x a l AG
Address: Industriestrasse 25
City: Holzkirchen
Postcode: 83607
Country: Germany

Scientific contact point

Organisation: H e x a l AG
Contact name: Biosimilar Clinical Trials Information Point

Public contact point

Organisation: H e x a l AG
Contact name: Biosimilar Clinical Trials Information Point

Locations

3 EU/EEA countries · 22 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ongoing, recruitment ended	29	8
Croatia	Ongoing, recruitment ended	7	2
Poland	Ongoing, recruitment ended	90	12
Rest of world India, Georgia, North Macedonia, United States, Serbia, Bosnia and Herzegovina	—	74	—

Investigational sites

Bulgaria

8 sites · Ongoing, recruitment ended

Acibadem City Clinic Tokuda University Hospital EAD

Neurology and Sleep Medicine Clinic, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya

Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD

N/A, Vassil Levski Bulevard 144a-A, 4003, Plovdiv

University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov

Nervous Diseases Clinic, Krasno Selo, Bulevard Gen Totleben 21, Sofiya

Medical Center Academica 2008 EOOD

N/A, Ulitsa Todor Kableshkov 2, 5809, Pleven

Diagnostics And Consultation Center Convex Ltd.

N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

Nervous Diseases Clinic, Bulevard Peshtersko Shose 66, 4002, Plovdiv

Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD

Nervous Diseases Clinic for Locomotor Disorders, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia

Medical Center Medica 2005 EOOD

N/A, Ulitsa Milin Kamik 51, Lozenets District, Sofia

Croatia

2 sites · Ongoing, recruitment ended

Opca Bolnica Varazdin

Department of Neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin

University Hospital Centre Zagreb

Department of Neurology, Ulica Mije Kispatica 12, 10000, Zagreb

Poland

12 sites · Ongoing, recruitment ended

Zanamed Medical Clinic Sp. z o.o.

N/A, Ul. Tomasza Zana 32b, 20-601, Lublin

Centrum Medyczne Neuroprotect

Centrum Medyczne NeuroProtect, Ul. Klaudyny 16c, 1 Piętro, Warsaw

Ilkowski I Partnerzy sp.p. Lekarzy

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy, Ul. Wierzbowa 2/2, 61-853, Poznan

Neuro-Medic Sp. z o.o.

Neuro-Medic Poradnia Wielospecjalistyczna, Ul. Zurawia 80, 40-686, Katowice

Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.

N/A, Ul. Glowackiego 8d/2, 67-100, Nowa Sol

Ma-Lek Clinical Sp. z o.o.

Ma-Lek Centrum Terapii SM, Ul. Zaleska 9, 40-571, Katowice

Neurocentrum Bydgoszcz Sp. z o.o.

N/A, Ul. Aleje Prof. Sylwestra Kaliskiego 28/U1, 85-796, Bydgoszcz

Euromedis Sp. z o.o.

N/A, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach

Oddział Neurologiczny, Ul. 3 Maja 13/15, 41-800, Zabrze

Med Polonia Sp. z o.o.

N/A, Obornicka 262, 60-693, Poznan

Centrum Neurologii Krzysztof Selmaj

N/A, ul. Tylna 12, 90-324, Łódź

Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.

N/A, Ul. Polnocna 8/3, 20-064, Lublin

Country notifications

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

Country	Trial start	Recruitment start	Recruitment end
Bulgaria	2025-07-03	2025-07-31	2026-05-20
Croatia	2025-07-02	2025-08-07	2026-05-20
Poland	2025-07-01	2025-07-14	2026-05-20

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-01-30	Poland	Acceptable 2025-05-26	2025-06-01
2	SUBSTANTIAL MODIFICATION	SM-1	2025-09-29	Poland	Acceptable 2025-11-13	2025-11-15
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-03-13	Poland	Acceptable 2025-11-13	2026-03-13