A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

NCT02367183 | Completed Phase 1 DMC

• 1 other identifier: GED-0301-CD-001
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 50

Brief Summary

This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.

Conditions

Crohn Disease

Keywords

Crohn's Disease; Active Crohn's Disease; GED-0301; Endoscopic; Double-Blind; IBD; Mongersen

Outcome Measures

Primary Outcomes (1)

• Change in SES-CD Score

  The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.

  Week 12

Secondary Outcomes (2)

• Proportion of subjects achieving a clinical remission, defined as a CDAI score < 150 at Induction Week 4

  Week 4

• Adverse Event (AE)

  Up to 97 weeks

Study Arms (3)

GED-0301 160mg QD 12 WK

EXPERIMENTAL

GED-0301 160 mg once daily (QD) for 12 weeks

Drug: GED-0301

GED-0301 160 mg QD 8 WK

EXPERIMENTAL

GED-0301 160 mg QD for 8 weeks followed by 4 weeks of placebo

Drug: GED-0301; Drug: Placebo

GED-0301 160 mg QD 4 WK

EXPERIMENTAL

GED-0301 160 mg QD for 4 weeks followed by 8 weeks of placebo

Drug: GED-0301; Drug: Placebo

Interventions

GED-0301 DRUG

GED-0301 160 mg QD 4 WK; GED-0301 160 mg QD 8 WK; GED-0301 160mg QD 12 WK

Placebo DRUG

GED-0301 160 mg QD 4 WK; GED-0301 160 mg QD 8 WK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male or female who is ≥18 years at the time of signing the Informed Consent Form (ICF).
• Understand and voluntarily sign an Informed Consent Form (ICF) prior to conducting any study related assessments/procedures.
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of Crohn's Disease (CD) with a duration of at least 3 months prior to screening.
• Diagnosis of ileitis, ileocolitis or colitis , as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging \[MRI\], computed tomography \[CT\] scan) evaluation performed within 2 years prior to screening. Subjects with colitis restricted to the left colon will not be allowed in the trial.
• Active disease, defined as Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 (range: 0 to 600) at screening.
• Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 7 at screening. Subjects with ileitis only will require Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥ 4
• Must have failed or experienced intolerance to at least one of the following:
• aminosalicylates, budesonide, systemic corticosteroids, immunosuppressants (ie, 6 mercaptopurine \[6-MP\], azathioprine \[AZA\], or methotraxate \[MTX\]) or tumor necrosis factor-α tumor necrosis factor-α (TNF-α) blockers (eg, infliximab, adalimumab or certolizumab) .
• Subjects receiving oral aminosalicylates may continue their use during the study, provided that dose has been stable for at least 2 weeks prior to screening. The dose of oral aminosalicylates must remain stable through the duration of the study or early termination from the study. If oral aminosalicylates have been recently discontinued, treatment must have been stopped at least 2 weeks prior to screening.
• Subjects receiving oral corticosteroids may continue their use during the Induction Phase, provided that the dose (prednisone ≤ 20 mg/day or equivalent, budesonide ≤ 9 mg/day) has been stable for 3 weeks prior to screening. If oral corticosteroids were recently discontinued, discontinuation must have been completed at least 4 weeks prior to screening. Corticosteroid doses should remain stable until the subject is eligible to start corticosteroids tapering.
• Subjects receiving immunosuppressants, such as , 6 mercaptopurine (6-MP), azathioprine (AZA), or methotraxate (MTX) may continue their use during the study, provided that treatment was initiated ≥ 12 weeks prior to screening. The dose of immunosuppressants must be at a stable dose for ≥ 8 weeks prior to the Baseline Visit and must remain stable through the duration of the study or early termination from the study. Subjects who discontinued immunosuppressants should have stopped them at least 8 weeks prior to screening.
• Must meet the following laboratory criteria:
• White blood cell count ≥ 3000/mm3 (≥ 3.0 X 10\^9//L) and \< 14,000/mm3 (\< 14.0 X 10\^9/L)
• Platelet count ≥ 100,000/mm3 (≥ 100 X 10\^9/L)

You may not qualify if:

• Diagnosis of Crohn's colitis restricted to the left colon , ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
• Local manifestations of Crohn's Disease (CD) such as strictures, abscesses, fistula, short bowel syndrome or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy.
• Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to screening.
• Subjects with an ileostomy or a colostomy.
• Stool positive for any enteric pathogen or C. difficile toxin at screening.
• History of colorectal cancer or colorectal dysplasia.
• Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn) for the treatment of CD. In addition, prior use of any of these treatment modalities for an indication other than CD within 8 weeks of screening is also excluded.
• Use of intravenous (IV) corticosteroids within 2 weeks of screening.
• Use of topical treatment with 5 aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks of screening
• Use of antibiotic therapy for the treatment of Crohn's Disease (CD) within 3 weeks of screening.
• Use of cholestyramine within 3 weeks of screening.
• Prior treatment with more than 2 tumor necrosis factor-α (TNF-α) blockers.
• Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).
• Use of tumor necrosis factor-α (TNF-α) blockers within 12 weeks of the screening
• Administration of total parenteral nutrition (TPN) within 4 weeks of screening.

Sponsors & Collaborators

• Celgene: lead

Study Sites (50)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Macks Research Group

Newport Beach, California, 92660, United States

Location

Medical Associates Research Group

San Diego, California, 902123, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

University of Florida Shands Endoscopy Center University of Florida at Gainesville

Gainesville, Florida, 32608, United States

Location

Borland - Groover Clinic

Jacksonville, Florida, 32256, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30342, United States

Location

Gastroenterology Specialists

Suwanee, Georgia, 30024, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Metropolitan Gastroenterology

Chevy Chase, Maryland, 20815, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Concorde Medical Group

New York, New York, 10016, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States

Location

The Management Associates

Wilmington, North Carolina, 28403, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Nashville Gastrointestinal Specialists

Nashville, Tennessee, 37211, United States

Location

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 75231, United States

Location

Digestive Disease Consultants

Grapevine, Texas, 76051, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Digestive Disease Consultants - Southlake

Irving, Texas, 75039, United States

Location

University of Utah Division of Gastroenterology

Salt Lake City, Utah, 84132, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Centre For Digestive Diseases

Five Dock, New South Wales, 2046, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Concord Repatriation General Hospital

Concord, 2139, Australia

Location

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

PerCuro Clinical Research

Victoria, British Columbia, V8V 3P9, Canada

Location

London Health Science Center U. Hospital

London, Ontario, N6A 5A5, Canada

Location

McMaster University Medical Centre

West Hamilton, Ontario, L8N 3Z5, Canada

Location

Szent Imre Korhaz

Budapest, 1115, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, 6720, Hungary

Location

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, 975 17, Slovakia

Location

Univerzitna nemocnica Bratislava

Bratislava, 82606, Slovakia

Location

IBD Centrum s.r.o.

Bratislava, 83104, Slovakia

Location

KM Management, spol. s r.o.

Nitra, 949 01, Slovakia

Location

GASTRO I., s.r.o.

Prešov, 080 01, Slovakia

Location

Related Publications (1)

• Feagan BG, Sands BE, Rossiter G, Li X, Usiskin K, Zhan X, Colombel JF. Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease. Gastroenterology. 2018 Jan;154(1):61-64.e6. doi: 10.1053/j.gastro.2017.08.035. Epub 2017 Aug 25.

  PMID: 28847751 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

GED0301

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Guillermo Rossiter, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: April 8, 2015
• Primary Completion: September 6, 2016
• Study Completion: December 14, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

HU (2); SL (5); US (34); AU (5); CA (4)