NCT04877457: CELLO

Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.

Terminated Phase 4 Results posted Last updated 9 October 2024

What this trial tests

Phase 4 trial testing Ocrelizumab in Radiologically Isolated Syndrome in 3 participants. Terminated before completion.

Timeline

15 February 2022

Primary endpoint
12 June 2023

12 June 2023

Quick facts

Lead sponsor	Yale University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	3
Start date	15 February 2022
Primary completion	12 June 2023
Estimated completion	12 June 2023
Sites	4 locations across United States

Drugs / interventions tested

• Ocrelizumab (OCRELIZUMAB) — full drug profile →
• Placebo

Conditions studied

• Radiologically Isolated Syndrome — all drugs for Radiologically Isolated Syndrome →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Yale University

Who can join

Adults 18 to 55, any sex, with Radiologically Isolated Syndrome or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: The period of time over which adverse event data were collected was over one year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ocrelizumab

Serious: 0/2 (0%)

Deaths: 0/2

Placebo

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (3 terms — click to expand)

Reaction	System	Ocrelizumab	Placebo
Positional headache	General disorders	—	—
Blurry vision	Eye disorders	—	—
Left ear infection	Ear and labyrinth disorders	—	—

Data from ClinicalTrials.gov NCT04877457 adverse events section.

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized 1:1 to receive ocrelizumab treatment or placebo (standard of care).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Secondary Prevention in Radiologically Isolated Syndromes and Prodromal Stages of Multiple Sclerosis.
   Amato MP, De Stefano N, Inglese M, Morena E, et al · · 2022 · cited 12× · PMID 35359637 · DOI 10.3389/fneur.2022.787160
2. The CELLO trial: Protocol of a planned phase 4 study to assess the efficacy of Ocrelizumab in patients with radiologically isolated syndrome.
   Longbrake EE, Hua LH, Mowry EM, Gauthier SA, et al · · 2022 · cited 10× · PMID 36031693 · DOI 10.1016/j.msard.2022.104143
3. The Brave New World of Early Treatment of Multiple Sclerosis: Using the Molecular Biomarkers CXCL13 and Neurofilament Light to Optimize Immunotherapy.
   Pachner A. · · 2022 · cited 8× · PMID 36140203 · DOI 10.3390/biomedicines10092099
4. 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
5. Processing speed and memory test performance are associated with different brain region volumes in Veterans and others with progressive multiple sclerosis.
   Spain RI, Hildebrand A, Waslo CS, Rooney WD, et al · · 2023 · cited 5× · PMID 37360346 · DOI 10.3389/fneur.2023.1188124
6. Anticipating Clinical Onset in Multiple Sclerosis: Challenges and Opportunities.
   Nociti V, Romozzi M. · · 2025 · PMID 41440961 · DOI 10.3390/jpm15120598