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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:December 2, 2015
End Date:March 31, 2022
Contact:Celgene True North Study True North Study
Email:truenorth@celgene.com
Phone:1-844-266-9299

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

The purpose of the trial is to determine the long-term safety and efficacy of RPC1063 in
patients diagnosed with moderate to severe ulcerative colitis.

The trial is an open label extension study. Eligible patients from the RPC01-3101 and
RPC01-202 trials will have the option to enroll in this trial to receive study medication for
up to 5 years or until marketed approval

Inclusion Criteria:

1. Previously participated in a trial of RPC1063 for UC and meet the criteria for
participation in the open label extension as outlined in the prior trial

2. Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the trial
until completion of the 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 trial are the following:

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

- progestogen-only hormonal contraception associated with inhibition of ovula-tion,
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 patients:

Must agree to use a latex condom during sexual contact with women of childbearing
po-tential while participating in the trial until completion of the safety follow-up
visit.

All patients:

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

3. Must provide written informed consent and have the ability to be compliant with the
schedule of protocol assessments, which must be obtained prior to any trial-related
procedures.

Exclusion Criteria:

1. Have received any of the following therapies since the first dose of investigational
drug in the prior RPC1063 trial:

- Treatment with a biologic agent

- Treatment with an investigational agent other than RPC1063

- Treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or
fingolimod

- Treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4,
cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body
irradiation, bone marrow transplantation, alemtuzumab, daclizumab)

- Treatment with a live vaccine within 4 weeks prior to Visit 1 of this trial

2. Are currently receiving or require initiation of any of the following therapies:

- Treatment with corticosteroids at a dose that exceeds the prednisone equivalent
of >40 mg

- Treatment with immunosuppressive agents (eg, azathioprine, 6-MP, or methotrexate)

- Chronic non-steroidal anti-inflammatory drug (NSAID) use (Note: occasional use of
NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstru-al
cramps] and aspirin up to 325 mg/day is permitted)

- Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two
or more agents in combination known to prolong PR interval

3. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)

4. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine,
psychiatric or other major systemic disease making implementation of the protocol or
interpretation of the trial difficult or that would put the patient at risk by
participating in the trial or that would have required a patient to discontinue
treatment in previous RPC1063 trial

5. Clinically relevant cardiovascular conditions, including history or presence of recent
myocardial infarction, unstable angina, stroke, transient ischemic attack,
decompensated heart failure requiring hospitalization, Class III/IV heart failure,
sick sinus syndrome, or severe untreated sleep apnea

6. Liver function impairment or persisting elevations of aspartate aminotransferase (AST)
or alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN), or direct
bilirubin > 3 times the ULN

7. FEV1 or FVC < 50% of predicted values
We found this trial at
92
sites
100 East Newton Street
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
550 University Boulevard
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
740 South Limestone Street
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
?
mi
from
New York, NY
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1800 Orleans Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21208
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beavercreek, Ohio 45432
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Belton, Missouri 64012
?
mi
from
Belton, MO
Click here to add this to my saved trials
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
4190 Juan D. Peron
Buenos Aires, C1181
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45206
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
3001 Executive Drive
Clearwater, Florida 33762
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Costa Mesa, California 92627
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
3409 Worth Street
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
10454 Northwest 31st Terrace
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
3551 Roger Brooke Drive
Fort Sam Houston, Texas 78235
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
7760 West 38th Avenue
Lakewood, Colorado 80215
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
?
mi
from
Largo, FL
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Marlborough, Massachusetts 01752
?
mi
from
Marlborough, MA
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
1611 Northwest 12th Avenue
Miami, Florida 33130
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
New Port Richey, Florida
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
New Smyrna Beach, Florida 32174
?
mi
from
New Smyrna Beach, FL
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
North Little Rock, Arkansas
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palmetto Bay, Florida
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
4820 Park Boulevard North
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rocky Mount, North Carolina 27804
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
11457 Olde Cabin Road
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
520 East Euclid Avenue
San Antonio, Texas 78212
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1710 Scott Street
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Springfield, Ohio 45504
?
mi
from
Springfield, OH
Click here to add this to my saved trials
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
7801 York Road
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tucson, Arizona 85712
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
7566 North la Cholla Boulevard
Tucson, Arizona 85741
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Washington, Missouri 63090
?
mi
from
Washington, MO
Click here to add this to my saved trials
Zephyrhills, Florida 33542
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials