Last reviewed · How we verify
NCT05090371: SOSTOS
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
Phase 4 trial testing Ofatumumab in Relapsing-Remitting Multiple Sclerosis in 136 participants. Participants enrolled and being followed up; not accepting new ones.
13 April 2027
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 2 March 2022 |
| Primary completion | 13 April 2027 |
| Estimated completion | 13 April 2027 |
| Sites | 43 locations across Canada, United States |
Drugs / interventions tested
- Ofatumumab (OFATUMUMAB) — full drug profile →
- Disease modifying treatment (DMT) — full drug profile →
Conditions studied
- Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 50, any sex, with Relapsing-Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
B cell targeted therapies in inflammatory autoimmune disease of the central nervous system.
Furman MJ, Meuth SG, Albrecht P, Dietrich M, et al · · 2023 · cited 24× · PMID 36969208 · DOI 10.3389/fimmu.2023.1129906 -
Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.
Tramacere I, Virgili G, Perduca V, Lucenteforte E, et al · · 2023 · cited 10× · PMID 38032059 · DOI 10.1002/14651858.cd012186.pub2 -
Current use of fluid biomarkers as outcome measures in Multiple Sclerosis (MS): a review of ongoing pharmacological clinical trials.
Schilke ED, Remoli G, Funelli E, Galimberti M, et al · · 2024 · cited 7× · PMID 38117403 · DOI 10.1007/s10072-023-07228-3 -
What Do We Know So Far about Ofatumumab for Relapsing Multiple Sclerosis? A Meta-Analytical Study.
Taj HM, Talib M, Siddiqa S, Sarfraz A, et al · · 2022 · cited 1× · PMID 36360540 · DOI 10.3390/healthcare10112199
Verify or expand the search:
- PubMed search for NCT05090371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ofatumumab
Trials testing the same drug.
- NCT06486779 — Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study · recruiting
- NCT06867991 — Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis · Phase 3 · recruiting
- NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients · active not recruiting
- NCT07353216 — Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Se · recruiting
- NCT05809986 — Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study · recruiting
Other recruiting trials for Relapsing-Remitting Multiple Sclerosis
Currently open trials in the same condition.
- NCT05123703 — A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Re · Phase 3 · active not recruiting
- NCT04530318 — Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis · Phase 2 · active not recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05090371 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 30 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05090371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing