Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

December 2, 2013 updated by: Genzyme, a Sanofi Company

Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

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
      • Brisbane, Australia, QLD 4000
      • Hamilton, Australia, 3204
      • Sydney, Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
    • Queensland
      • Caboolture, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Frankston, Victoria, Australia, 3199
      • Melbourne, Victoria, Australia, 3084
  • Brazil
      • Santos, Brazil, 11075-900
      • Sao Paulo, Brazil, 0122-1020
    • SP
      • Botucatu, SP, Brazil, 18618-970
      • Sao Paulo, SP, Brazil, 04023-900
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-205
      • Florianopolis, Santa Catarina, Brazil, 88020-210
  • Bulgaria
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1527
      • Varna, Bulgaria, 9010
  • Canada
      • Quebec, Canada, G1R 2J6
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
    • New Brunswick
      • St. John, New Brunswick, Canada, E2K 1J5
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
      • Kingston, Ontario, Canada, K7L 5G2
      • Ottawa, Ontario, Canada, K1H 8L6
    • Quebec
      • Montreal, Quebec, Canada, H3H 1V4
      • St-Charles-Borromee, Quebec, Canada, J6E 2C3
  • Israel
      • Haifa, Israel, 31048
      • Jerusalem, Israel, 91120
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64299
      • Zerifin, Israel, 70300
  • New Zealand
      • Auckland, New Zealand, 0622
      • Dunedin, New Zealand, 9016
      • Hamilton, New Zealand, 3204
      • Tauranga, New Zealand
  • Romania
      • Bucharest, Romania
      • Bucharest, Romania, 011025
      • Craiova, Romania, 200670
  • Russian Federation
      • Kazan, Russian Federation, 420011
      • Krasnodar, Russian Federation, 350086
      • Moskva, Russian Federation, 119992
      • Sankt-Peterburg, Russian Federation
      • St. Petersburg, Russian Federation, 197110
      • St. Petersburg, Russian Federation, 194291
      • St. Petersburg, Russian Federation, 194017
  • South Africa
      • Durban, South Africa, 4001
      • Durban, South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6057
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
      • Johannesburg, Gauteng, South Africa
      • Pretoria, Gauteng, South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa
      • Cape Town, Western Cape, South Africa, 7530
      • Cape Town, Western Cape, South Africa, 7463
      • Cape Town, Western Cape, South Africa, 7708
      • Somerset West, Western Cape, South Africa, 7130
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Ivano-Frankovsk, Ukraine
      • Kharkiv, Ukraine, 61039
      • Kiev, Ukraine
      • Lviv, Ukraine, 79013
      • Zaporozhye, Ukraine
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • California
      • Orange, California, United States, 92868
      • San Francisco, California, United States, 94117
    • Colorado
      • Lakewood, Colorado, United States, 80215
      • Littleton, Colorado, United States, 80120
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Gainesville, Florida, United States, 32610-0254
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Maryland
      • Hagerstown, Maryland, United States, 21740
      • Lutherville, Maryland, United States, 21093
      • Towson, Maryland, United States, 21204
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0330
      • Chesterfield, Michigan, United States, 48047
      • Troy, Michigan, United States, 48098
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
    • Missouri
      • Mexico, Missouri, United States, 65265
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • Great Neck, New York, United States, 11021
      • Mineola, New York, United States, 11501-3987
      • New York, New York, United States, 10028
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Dayton, Ohio, United States, 45440
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Texas
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Chesapeake, Virginia, United States, 23320
      • Christiansburg, Virginia, United States, 24073
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23249-0002
    • Washington
      • Seattle, Washington, United States, 98195
      • Wenatchee, Washington, United States, 98801

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Male or female, age >/= 18 years
  3. Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
  4. Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)

  5. If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:

    • Oral therapy with salicylates (mesalamine, sulfasalazine, olsalazine, or balsalazide) for Crohn's disease
    • Antibiotics or probiotics for Crohn's disease
    • Topical rectal therapy with mesalamine

  6. Females of child-bearing potential:

    Negative pregnancy test within 72 hours prior to receiving the first dose of study drug

  7. Sexually-active males and females of child-bearing potential:

    Agreement to use adequate method of contraception throughout the study

  8. Ability to self-inject study drug or availability of a designee who can do so

Exclusion Criteria:

  1. Pregnancy or breast-feeding
  2. Colostomy or ileostomy
  3. Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
  4. GI surgery within 6 months prior to receiving the first dose of study drug
  5. Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected

  6. Positive stool test results for any of the following:

    Bacteria:

    • Salmonella spec.
    • Shigella spec.
    • Campylobacter spec.

    Bacterial toxin:

    • Clostridium difficile

    Ova and parasites:

    • Amoeba spec.
    • Giardia spec.
    • Cryptosporidium spec.

  7. Any of the following laboratory abnormalities:

    • Serum creatinine >/= 2.0 mg/dL
    • Alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >/=; 2 x the upper limit of normal
    • Hemoglobin (Hgb) < 8.0 g/dL
    • Absolute neutrophil count (ANC) </= 1,000 cells/µL or > cells 20,000/µL
  8. Planned in-patient hospitalization during the study
  9. Presence or history of cancer of any type (except treated basal cell carcinoma) or definite dysplasia of the colon within the last 5 years

  10. Use of any of the following medications during the specified period of time prior to receiving the first dose of study drug:

    At any time:

    • Recombinant human GM CSF (sargramostim or molgramostim)
    • Granulocyte colony-stimulating factor (G CSF; filgrastim or pegfilgrastim)
    • Natalizumab 8 weeks: or 5 half-lives (whichever is longer)
    • Licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab 4 weeks:
    • 6-mercaptopurine
    • Azathioprine
    • Cyclophosphamide
    • Methotrexate
    • Mycophenolate mofetil
    • Tacrolimus
    • Cyclosporine
    • Thalidomide
    • Glucocorticoids, including budesonide and prednisone, or local glucocorticoid therapy for Crohn's disease
    • Any other immunosuppressive drugs
  11. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug
  12. Use of nutritional therapy (parenteral nutrition or enteral nutrition with elemental or semi-elemental diets) within 4 weeks prior to receiving the first dose of study drug. If the physician judges that nutritional supplementation is needed, enteral nutritional supplements will be allowed for patients who have been receiving a stable regimen for at least 4 weeks prior to receiving the first dose of study drug and that is intended to continue through the 8 week treatment period.
  13. History of allergy to yeast products or to sargramostim or to any other excipient of the study drug formulation
  14. Active drug or alcohol abuse
  15. Clinically important co-morbid conditions unrelated to Crohn's disease as determined by the investigator
  16. Previous randomization into this study, or into any other study of the sponsor's sargramostim development program

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
Intervention / Treatment
Experimental: Arm 1
Drug: Sargramostim (Leukine)
Sargramostim 6 mcg/kg subcutaneously once daily
Other Names:
  • BAY86-5326
Placebo Comparator: Arm 2
Drug: Placebo
Placebo subcutaneously once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To induce clinical remission and/or clinical response following 8 weeks of treatment
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety profile of sargramostim (including development of antibodies against sargramostim)
Time Frame: During study treatment
During study treatment
To assess quality of life (QoL)
Time Frame: During study treatment
During study treatment

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

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

January 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 23, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 310187
  • 91494
  • NOVEL8

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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