Last reviewed · How we verify
NCT07389590
A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab
Phase 4 trial testing Ublituximab in Multiple Sclerosis in 50 participants. Currently enrolling.
1 October 2028
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 10 February 2026 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 March 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ublituximab — full drug profile →
- Ocrelizumab (OCRELIZUMAB) — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Johns Hopkins University
Who can join
Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of Patients with Wearing-Off
Time frame: From month 1 up to 11 months
The proportion of patients with the wearing-off phenomenon (as defined below). Wearing off is defined as either worsening in any Neuro-QoL (Quality of Life in Neurological Disorders) fatigue, depression, upper and lower extremity scores (moving from a lower category of symptom severity to a higher category, based on previously defined cutoff scores) or 0.5-point worsening in average SymptoMScreen
Sponsor's own description
The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07389590
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ublituximab
Trials testing the same drug.
- NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
- NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis · NA · not yet recruiting
- NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection · Phase 2 · not yet recruiting
- NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis · Phase 4 · recruiting
- NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis · EARLY_PHASE1 · recruiting
Other recruiting trials for Multiple Sclerosis
Currently open trials in the same condition.
- NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
- NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
- NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
- NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
- NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting
Other Johns Hopkins University trials
Trials by the same sponsor.
- NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
- NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
- NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
- NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
- NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · 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 NCT07389590 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 1 May 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/NCT07389590.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing