Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (Touchstone)

May 14, 2021 updated by: Celgene

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven, campus Gasthuisberg
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Multiprofile Hospital for Active Treatment Kaspela
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
      • Sofia, Bulgaria, 1407
        • University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
      • Sofia, Bulgaria, 1527
        • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
      • Sofia, Bulgaria, 1431
        • UMHAT Sv Ivan Rilski EAD
      • Sofia, Bulgaria, 1632
        • Multiprofile Hospital for Active Treatment Doverie AD
      • Sofia, Bulgaria, 1712
        • Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD
      • Sofia, Bulgaria, 1797
        • Multiprofile Hospital for Active Treatment Sofiamed
      • Varna, Bulgaria, 9010
        • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre, University Hospital
  • Greece
      • Athens, Greece, 106 76
        • Evaggelismos General Hospital
      • Ioannina, Greece, 45110
        • University Hospital of Ioannina
      • Larissa, Greece, 41110
        • University Hospital Of Larissa
  • Hungary
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary, 1136
        • Pannónia Magánorvosi Centrum
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Debrecen, Hungary, 4025
        • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Holon, Israel, 5822012
        • Wolfson Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705717
        • Yeungnam University Medical Center
      • Daejon, Korea, Republic of, 302718
        • Konyang University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 110746
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of, 130702
        • Kyunghee University Medical Center
      • Suwon, Korea, Republic of, 442723
        • The Catholic University of Korea, St.Vicent's Hospital
      • Wonju, Korea, Republic of, 220701
        • Wonju Christian Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Lower Hutt, New Zealand, 5010
        • Hutt Valley District Health Board
      • Milford, New Zealand, 0620
        • North Shore Hospital
  • Poland
      • Bialystok, Poland
        • SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
      • Czestochowa, Poland, 42-217
        • Niepubliczny Zaklad Opieki Zdrowotnej Intermed
      • Elblag, Poland, 82-300
        • Elblaski Szpital Specjalistyczny z Przychodnia
      • Gdansk, Poland, 80-807
        • Przychodnia Lekarska Nowy Chelm
      • Katowice, Poland, 40-660
        • Economicus - NZOZ ALL-MEDICUS
      • Ksawerow, Poland, 95-054
        • Centrum Opieki Zdrowotnej Orkan Med
      • Lodz, Poland, 90-302
        • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
      • Lublin, Poland, 20-090
        • Instytut Medycyny Wsi
      • Rzeszow, Poland, 35-068
        • MEDICOR Centrum Medyczne
      • Warsaw, Poland, 03-580
        • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
      • Warszawa, Poland, 02-797
        • Niepubliczny Zaklad Opieki Zdrowotnej Triclinium
      • Wroclaw, Poland, 53-114
        • LexMedica Osrodek Badan Klinicznych
  • Russian Federation
      • Krasnoyarsk, Russian Federation, 660022
        • Regional Clinical Hospital
      • Moscow, Russian Federation, 119991
        • SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF
      • Nizhniy Novgorod, Russian Federation, 603126
        • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
      • Novosibirsk, Russian Federation, 630084
        • Novosibirsk State Medical University
      • Omsk, Russian Federation, 644043
        • SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
      • Rostov on Don, Russian Federation, 344022
        • SEIHPE Rostov State Medical University of MoH of RF
      • Saint Petersburg, Russian Federation, 191163
        • Russian Medical Military Academy na SMKirov
      • Saint Petersburg, Russian Federation, 196247
        • City Hospital 26
      • Samara, Russian Federation, 443000
        • Medical Company Hepatolog
  • Slovakia
      • Ilava, Slovakia, 01901
        • Slovak Research Center
      • Nitra, Slovakia, 94901
        • Specializovana Nemocnica Svorada Zobor
      • Presov, Slovakia, 080 01
        • GASTRO I., s.r.o.
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine, 76014
        • Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
      • Kharkiv, Ukraine, 61039
        • Institute of Therapy n.a. L.T. Maloy of NAMS of Ukraine
      • Kyiv, Ukraine, 04201
        • Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
      • Kyiv, Ukraine, 1133
        • Order of the Red Star MMMCC MMCH Clinic of Gastroenterology
      • Kyiv, Ukraine, 2232
        • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
      • Lviv, Ukraine, 79059
        • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21018
        • Vinnytsia Regional Clinical
      • Vinnytsya, Ukraine, 21029
        • Medical Clinical Research Center "Health Clinic"
      • Zaporizhzhia, Ukraine, 69600
        • Municipal Institution Zaporizhzhia
      • Zaporizhzhya, Ukraine, 69065
        • Zaporizhzhya city multidisciplinary clinical hospital #9
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • La Jolla, California, United States, 92037
        • University Of California San Diego
      • Oceanside, California, United States, 92056
        • Alliance Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates, LLC
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Towson, Maryland, United States, 21204
        • Endoscopic Microsurgery Associates
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ulcerative colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

  • Current use of anti-TNF agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ozanimod 0.5 mg
Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Ozanimod capsules by mouth daily.
Other Names:
  • Zeposia, RPC 1063
Experimental: Ozanimod 1 mg
Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.
Drug: Ozanimod
Ozanimod capsules by mouth daily.
Other Names:
  • Zeposia, RPC 1063
Placebo Comparator: Placebo
Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Time Frame: Week 8

Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.

The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal bleeding Subscore (RBS)
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA)

Clinical Remission was based on the 4-component Mayo definition.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Time Frame: Week 8

Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.

The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.

Clinical Respone was based on the 4-component Mayo definition.
Week 8
Change From Baseline in Mayo Score at Week 8
Time Frame: Baseline to Week 8

The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal bleeding Subscore (RBS)
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA)
Baseline to Week 8
Percentage of Participants With Mucosal Healing at Week 8
Time Frame: Week 8

Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.

The endoscopy scale:

0 = Normal or inactive disease

  1. = Mild disease (erythema, decreased vascular pattern, mild friability)
  2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
  3. = Severe disease (spontaneous bleeding, ulceration)
Week 8
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Time Frame: Week 32

Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point.

The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal bleeding Subscore (RBS)
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA)
Week 32
Percentage of Participants Who Achieved Clinical Response at Week 32
Time Frame: Week 32

Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.

The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.

  • Stool Frequency Subscore (SFS)
  • Rectal bleeding Subscore (RBS)
  • Endoscopy Subscore
  • Physician's Global Assessment (PGA)
Week 32
Percentage of Participants With Mucosal Healing at Week 32
Time Frame: Week 32

Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.

The endoscopy scale:

0 = Normal or inactive disease

  1. = Mild disease (erythema, decreased vascular pattern, mild friability)
  2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)
  3. = Severe disease (spontaneous bleeding, ulceration)
Week 32
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
Time Frame: From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
Time Frame: From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
Time Frame: From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years
A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.
From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: AnnKatrin Petersen, MD, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPC01-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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