Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Key facts

Study ID

NCT03259334

Run by

Shire

People needed

380

Starts

2018-02-09

Expected to finish

2020-10-23

Last updated by the study team

2021-06-14

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
• Participants must be between greater than or equal to (>=)16 and <=80 years of age at the time of the signing of the informed consent/assent form.
• Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index (BMI) >=16.5 kilogram per square meter (kg/m\^2).
• Participants must have a documented diagnosis of UC for >=3 months before screening. The following must be available in each participant's source documentation:
• A biopsy report to confirm the histological diagnosis.
• A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
• Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy, including biopsy sample collection, during screening after all other inclusion criteria have been met.
• Participants must have moderate to severe active UC, defined as a total Mayo score of >=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1, and stool frequency subscore >=1 at baseline.
• Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
• Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).
• Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
• Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

You may not qualify if…

• Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
• Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
• Participants with past medical history or presence of toxic megacolon.
• Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
• Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
• Participants at risk for colorectal cancer include, but are not limited to:
• Participants with extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of age.
• Participants >=50 years of age at the time of signing of the informed consent form.
• Participants have had prior treatment with SHP647.
• Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
• Participants have received anti-TNF treatment within 60 days before baseline.
• Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.
• Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.
• Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
• Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
• Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.
• Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.
• Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.
• Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [Participants with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.
• Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis, general infections, heart failure, or malignancy.
• Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon gamma release assay (IGRA) performed.
• Participants who have no history of previously diagnosed active or latent tuberculosis are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.
• An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.
• If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent tuberculosis, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.
• Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action). This consultation must be included in source documentation.

Where it is running

• OM Research LLC - Lancaster - ClinEdge - PPDS — Lancaster, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Asthma and Allergy Associates PC - CRN - PPDS — Colorado Springs, Colorado, United States
• Advanced Clinical Research Network — Coral Gables, Florida, United States
• Nuren Medical and Research Center — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Omega Research Consultants LLC - Clinedge - PPDS — Orlando, Florida, United States
• East Coast Institute for Research, LLC — Saint Augustine, Florida, United States
• Gastrointestinal Diseases, Inc. Research — Columbus, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Medisphere Medical Research Center LLC — Evansville, Indiana, United States
• Laporte County Institute For Clinical Research — Michigan City, Indiana, United States
• Clinical Trials of SWLA LLC — Lake Charles, Louisiana, United States
• Louisiana Research Center LLC — Shreveport, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Digestive Health Center PA — Ocean Springs, Mississippi, United States
• New York Total Medical Care PC — Brooklyn, New York, United States
• Piedmont Healthcare — Statesville, North Carolina, United States
• Consultants For Clinical Research Inc — Cincinnati, Ohio, United States
• Consultants For Clinical Research Inc — Cincinnati, Ohio, United States
• Consultants For Clinical Research Inc — Fairfield, Ohio, United States
• Allegheny Center For Digestive Health — Pittsburgh, Pennsylvania, United States
• Atria Clinical Research - Clinedge - PPDS — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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