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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

NCT02435992•Celgene

View on ClinicalTrials.gov

Summary

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

Detailed Description

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 to 75 years (at screening for Cohort 1 and 2)
•UC confirmed on endoscopy
•Moderately to severely active UC (May score 6-12)
•Currently receiving treatment with aminosalisylate, prednisone, or budesonide
•Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria

•Have severe extensive colitis as evidence by:
•Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
•Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
•Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
•Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
•History of uveitis or unknown macular edema
•Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Locations (372)

Arizona Digestive Health

Sun City, Arizona, United States

Adobe Clinical Research LLC

Tucson, Arizona, United States

Arkansas Gastroenterology, P.A.

North Little Rock, Arkansas, United States

Anaheim Clinical Trials

Anaheim, California, United States

Aurora Care Clinic

Costa Mesa, California, United States

Valley View Internal Medicine

Garden Grove, California, United States

Davita Clinical Trials, LLC

Huntington Beach, California, United States

University of California San Diego Medical Center

La Jolla, California, United States

OM Research

Lancaster, California, United States

University of Southern California - Keck School of Medicine

Los Angeles, California, United States

Key Dates

Start Date

June 17, 2015

Primary Completion Date

March 27, 2020

Completion Date

June 17, 2020

Last Updated

September 1, 2021

Enrollment

1,012

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

RPC1063

DRUG

Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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