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About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

339,504 studies
in
214 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 05/30/2020.
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Clinical Trials of Interest

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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 05/30/2020.
Displaying: 19 trials in your specialties ()
View trials across your selected specialties

Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Multiple Sclerosis
View Full Trial
INTERVENTION

Drug: RPC-1063

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Neurological Institute of Alabama, Birmingham, Alabama, United States

Brief Summary

This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For subjects who discontinue the study, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. If commercial drug is not available at the end of the study, subjects may be started on another medication as determined by their individual treating physician. Approximately 250 subjects with RMS will be recruited for this study. Subjects with RMS will be enrolled in this study if they have received ≤1 DMT, have an EDSS ≤ 3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be responsible for the overall conduct of the study at the site, confirmation of subject eligibility, routine study subject clinical management including for MS relapses, and management of AEs.

Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Healthy Volunteers
View Full Trial
INTERVENTION

Drug: Ozanimod, Drug: Cyclosporine

Eligibility
  • Ages: 18 to 55 Years (Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

ICON Early Phase Services, LLC, San Antonio, Texas, United States

Brief Summary

This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows: - Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg - Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Crohn Disease
View Full Trial
INTERVENTION

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Holland Center for Family Health, Peoria, Arizona, United States

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects

  • Status
    Not yet recruiting
  • Phase
    Phase 1
  • Condition
    Healthy Volunteer
View Full Trial
INTERVENTION

Drug: Ozanimod

Eligibility
  • Ages: 18 to 45 Years (Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

Brief Summary

This is a Phase 1, open-label, single-dose study. Approximately 24 Chinese healthy adult subjects will be enrolled to receive a single oral dose of ozanimod 0.46 mg or 0.92 mg (12 subjects per dose cohort). Subjects will be screened for participation within 28 days prior to dosing. Eligible subjects will be admitted to the clinical research unit (CRU) or hospital one day before dosing (Day -1) and will be domiciled until Day 15 (approximately 336 hours after ozanimod dosing). Serial PK blood samples for the measurement of plasma concentrations of ozanimod and active metabolites will be collected predose and up to 336 hours after ozanimod dosing. Physical examinations, 12-lead electrocardiograms, vital sign measurements, and clinical laboratory tests will be performed and adverse events and concomitant medications will be monitored throughout the study to assess safety. Subjects will be contacted by telephone approximately 30 ± 5 days after dosing for a follow-up safety assessment.

Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Ulcerative Colitis
View Full Trial
INTERVENTION

Drug: RPC1063, Drug: placebo

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Anaheim Clinical Trials, Anaheim, California, United States

Brief Summary

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Crohn Disease
View Full Trial
INTERVENTION

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

HonorHealth Research Institute, Scottsdale, Arizona, United States

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Crohn Disease
View Full Trial
INTERVENTION

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

  • Status
    Active, not recruiting
  • Phase
    Phase 3
  • Condition
    Multiple Sclerosis
View Full Trial
INTERVENTION

Drug: RPC1063

Eligibility
  • Ages: 18 to 55 Years (Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Xenosciences Inc, Phoenix, Arizona, United States

Brief Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Crohn Disease
View Full Trial
INTERVENTION

Drug: Ozanimod

Eligibility
  • Ages: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

General Hospital Celje, Celje, Slovenia

Brief Summary

This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.

Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Ulcerative Colitis
View Full Trial
INTERVENTION

Drug: RPC1063

Eligibility
  • Ages: 12 Years and older (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Adobe Clinical Research LLC, Tucson, Arizona, United States

Brief Summary

The purpose of this study is to determine the long-term safety of RPC1063 for the treatment of all patients with moderate to severe Ulcerative Colitis (UC) as well as the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. Additionally, to determine the long-term efficacy of RPC1063 for the treatment of adolescent patients with moderate to severe UC.