Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

NCT01628393 · View on ClinicalTrials.gov ↗

Study Summary

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Interventions

  • DRUG Placebo
  • DRUG Ozanimod

Study Locations (20)

Other

  • Cliniques Universitaires St-Luc — Brussels
  • Centre Hospitalier Chretien Clinique Saint Joseph — Montegnée
  • Clinique Saint-Pierre — Ottignies
  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD — Sofia
  • Sarajishvili Institute of Neurology — Tbilisi
  • LTD MediClubGeorgia — Tbilisi
  • Khechinashvili University Hospital — Tbilisi
  • Evaggelismos General Hospital — Athens
  • 401 Military Hospital of Athens — Athens
  • Georgios Papanikolaou General Hospital of Thessaloniki — Thessaloniki
  • Vaszary Kolos Korhaz — Esztergom
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele — Cantania
  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi — Czeladź
  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego — Grudziądz

California

  • Alta Bates Summit Medical Center — Berkeley
  • Neuro Pain Medical Center — Fresno
  • University of California Davis Medical Center — Sacramento

North Carolina

  • The Neurological Institute PA — Charlotte

Ohio

  • Neurology and Neuroscience Associates Inc. — Akron

Washington

  • The Polyclinic — Seattle

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2012-09-18
Est. Completion 2016-05-11
Phase Phase 2

Sponsor

Celgene

73 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01628393

The ClinicalTrials.gov registry entry for NCT01628393 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01628393 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01628393 about?

NCT01628393 is a clinical study titled "Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients". This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enh...

What is the current status of trial NCT01628393?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-09-18. Estimated completion is 2016-05-11.

What conditions does trial NCT01628393 study?

This clinical trial studies the following conditions: Relapsing Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01628393?

The interventions under investigation include: Placebo (DRUG), Ozanimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01628393?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01628393 being conducted?

This trial has 20 study locations across California, North Carolina, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial