This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

Back
Filter 25 trials Clear all
Filter by:

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

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

Drug: RPC1063

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

Drug: RPC1063

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
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.

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

  • Status Recruiting
    Recruiting
  • Condition Colitis, Ulcerative
    Colitis, Ulcerative
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Ozanimod, Other: Placebo

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

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Kokikai Tokatsu-Tsujinaka Hospital, Abiko, Japan

Brief Summary

Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.

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

  • Status Recruiting
    Recruiting
  • Condition Crohn Disease
    Crohn Disease
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Ozanimod, Other: Placebo

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

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
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.

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

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Ulcerative Colitis
    Ulcerative Colitis
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: RPC1063

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

Drug: RPC1063

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Adobe Clinical Research LLC, Tucson, Arizona, United States

Brief Summary

This is an open-label, multicenter, extension trial to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). The purpose of this extension trial is to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). Only those patients who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible

A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

  • Status Recruiting
    Recruiting
  • Condition Healthy Volunteers
    Healthy Volunteers
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: Ozanimod, Drug: Ozanimod

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

Drug: Ozanimod, Drug: Ozanimod

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

PPD Phase 1 Clinic, Austin, Texas, United States

Brief Summary

This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as follows: - Treatment Group A (reference): Current ozanimod capsule formulation - Treatment Group B (test): Ozanimod granule formulation participants will be screened within 28 days prior to dosing. Eligible participants will be admitted to the clinical research unit one day before dosing (Day -1) and will be domiciled until Day 15. On Day 1, a single oral dose of 0.92 mg of ozanimod will be administered using either the current capsule formulation (Group A) or the granule formulation (Group B). Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety assessment.

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

  • Status Recruiting
    Recruiting
  • Condition Crohn Disease
    Crohn Disease
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Ozanimod, Other: Placebo

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

Drug: Ozanimod, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

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

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.

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

  • Status Recruiting
    Recruiting
  • Condition Multiple Sclerosis
    Multiple Sclerosis
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: RPC-1063

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

Drug: RPC-1063

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
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 all subjects who finish the subject and for those who discontinue, 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. 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.

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

  • Status Recruiting
    Recruiting
  • Condition Crohn Disease
    Crohn Disease
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Ozanimod

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

Drug: Ozanimod

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

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

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.

COVID-19 Ozanimod Intervention Study

  • Status Recruiting
    Recruiting
  • Condition COVID-19
    COVID-19
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Ozanimod, Other: Standard of care

Eligibility
  • Ages: 18 to 85 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Ozanimod, Other: Standard of care

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hôpital de la Cité-de-la-Santé (CISSS de Laval), Laval, Quebec, Canada

Brief Summary

The virus SARS-CoV-2 causes severe pneumonia which, in a proportion of patients progresses towards an Acute Respiratory Distress Syndrome (ARDS) mainly related to the antiviral immune response. To date, there is no available treatment that significantly improves outcome of patients with COVID-19 pneumonia. Sphingosine-1-phosphate receptor 1 (S1P1) ligands control vascular leakage in the airways and sphingosine-1-phosphate (S1P) receptor ligands devoid of activity on sphingosine-1-phosphate receptor 3 (S1P3) show an excellent safety profile, including ozanimod. Critically, S1P1 ligands mildly impact, but do not compromise viral clearance and they reduced lung injury in preclinical models, even without concomitant use of antivirals and with a synergistic effect when associated to antiviral agents. Ozanimod was approved by the FDA for the treatment of relapsing multiple sclerosis at the end of March 2020, and was recently (October 2020) approved by Health Canada for the same indication. The investigators believe that this immune modulator is at the top of the list of agents that should be trialed in order to mitigate the morbidity and mortality of COVID-19. The primary objective is to substantiate the impact of ozanimod on key outcomes of COVID-19 patient progression, which will guide decision making around sample size and the choice of endpoints for future clinical trial.

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod

  • Status Recruiting
    Recruiting
  • Condition Liver Diseases, Digestive System Diseases
    Liver Diseases, Digestive System Diseases
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: Ozanimod

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: Ozanimod

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Miami Miller School of Medicine, Miami, Florida, United States

Brief Summary

This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the participant's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease. Participants will be enrolled in Groups 1 through 3 as follows: - Group 1 (mild hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 5 to 6. - Group 2 (moderate hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 7 to 9. - Group 3 (normal hepatic function): Approximately 8 to 16 participants will be matched to Participants in Groups 1 and 2. Normal hepatic function participants are allowed to match multiple hepatic impairment participants. Participants will be matched by sex, age (± 10 years), weight (± 20%), and smoking status.