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 06/04/2020.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

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

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

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

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/04/2020.

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

Clinicaltrials.gov identifier NCT03467958

Recruitment Status Recruiting

First Posted March 16, 2018

Last update posted April 7, 2020

Study Description

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.

  • Condition or Disease:Crohn Disease
  • Intervention/Treatment: Drug: Ozanimod
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 1040 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
  • Actual Study Start Date: August 2018
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: June 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks
Drug: Ozanimod
Ozanimod
Outcome Measures
  • Primary Outcome Measures: 1. Proportion of subjects with a CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Secondary Outcome Measures: 1. Proportion of subjects with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The SES-CD assesses the degree of inflammation.
  • 2. Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: Up to 234 Weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary
  • 3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 4. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to 234 Weeks ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
  • 5. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 6. Change from baseline in CDAI [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 7. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 8. Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 9. Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
  • 10. Proportion of subjects with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
    The SES-CD assesses the degree of inflammation.
  • 11. Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 12. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
    The CDEIS assesses the degree of endoscopic inflammation.
  • 13. Proportion of subjects with a PCDAI score of ≤ 10 points [ Time Frame: Up to 234 Weeks ]
    Pediatric Crohn's Disease Activity Index (PCDAI) is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991)
Eligibility Criteria
  • Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subjects who are not in clinical response or clinical remission after completing 12
weeks in the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience
relapse or who complete the Maintenance Study RPC01-3203, and subjects who complete a
study of ozanimod for Crohn's Disease and meet the criteria for participation in the
RPC01-3204 Study will have the opportunity to participate in this study.

2. Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive.

3. Subject must provide written informed consent prior to any study-related procedures,
and have the ability to comply with the Table of Events.

4. Female subjects of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the study
until completion of the 75-day Safety Follow-up Visit. Highly effective methods of
contraception are those that alone or in combination result in a failure rate of a Pearl
Index of less than 1% per year when used consistently and correctly. Acceptable methods of
birth control in the study are the following:

- Combined hormonal (containing oestrogen and progestogen) contraception, which may be
oral, intravaginal, or transdermal

- Progestogen-only hormonal contraception associated with inhibition of ovulation, which
may be oral, injectable, or implantable

- Placement of an intrauterine device (IUD)

- Placement of an intrauterine hormone-releasing system (IUS)

- Bilateral tubal occlusion

- Vasectomised partner

- Sexual abstinence

Male subjects:

Must agree to use a latex condom during sexual contact with women of childbearing potential
while participating in the study until completion of the 75-day Safety Follow-up Visit.

All subjects:

Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus
interruptus), spermicides only, and lactational amenorrhoea method are not acceptable
methods of contraception. Female condom and male condom should not be used together.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Exclusions Related to General Health:

1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological,
endocrine, psychiatric, or other major systemic disease making implementation of the
protocol or interpretation of the study difficult or that would put the subject at risk by
participating in the study

Exclusions Related to Medications:

Subject has received any of the following therapies since the first dose of IP in the prior
ozanimod study:

1. treatment with a biologic agent as well as other treatments for CD such as etrasimod,
filgotinib, upadacitinib

2. treatment with an investigational agent other than ozanimod

3. treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod or
other S1P modulators

4. treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4, cladribine,
rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone
marrow transplantation, alemtuzumab, daclizumab)

Subject is currently receiving or requires initiation of any of the following therapies:

1. treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40
mg

2. treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate)

Exclusions Related to Laboratory Results:

Subject has any clinically significant abnormality ECG results which in the opinion of the
investigator may put the subject at risk.

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 657 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Kanthi Kollengode, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03467958 History of Changes
  • Other Study ID Numbers: RPC01-3204, U1111-1203-8203, 2017-004295-55
  • First Posted: March 16, 2018 Key Record Dates
  • Last Update Posted: April 7, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Crohn's Disease
    Crohn Disease
    Oral
    Ozanimod
    Moderately active
    Severely active
    RPC01
    RPC01-3204
  • Additional relevant MeSH terms: Crohn Disease