Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection



Status:Available
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/28/2016
Start Date:May 2015
Contact:Michele Trucksis, MD, PhD
Email:mtrucksis@serestherapeutics.com
Phone:617-945-9626

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ECOSPOR II: An Expanded Access for Intermediate-size Patient Population and Open-Label Extension of Study SERES-004 to Evaluate SER-109 in Patients With Recurrent Clostridium Difficile Infection

This is an open-label study for patients who have a recurrence of Clostridium difficile
infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004
study has completed enrollment, SERES-005 was amended to allow expanded access in accordance
with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for
the SERES-004 study.

This is an open-label study of SER-109 in patients who received a dose of SER-109 or placebo
in Study SERES-004 and experienced a CDI recurrence within 8 weeks of receipt of study drug.
In addition, SERES-005 has been amended to expand access to treatment with SER-109 to an
intermediate-size patient population of adults 18 years of age or older with recurrent
Clostridium difficile infection (CDI) (a serious disease), who would have qualified for the
SERES-004 study.

Inclusion Criteria:

1. Signed informed consent, indicating that the patient understands the purpose of and
procedures required for the study. Patients who are unable to provide informed
consent will not be included in the study.

2. Male or female patients ≥ 18 years of age.

3. Previously enrolled in Study SERES-004 and had CDI recurrence within 8 weeks after
receipt of study drug, OR If not previously enrolled in Study SERES-004, a documented
history of ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current
episode with ≥ 1 of the historical episodes having the date, test results, and
antibiotic treatment received documented. Efforts should be made to acquire history
of additional CDI episodes.

4. If not previously enrolled in Study SERES-004, a qualifying episode of CDI as defined
by:

1. ≥ 3 unformed stools per day for 2 consecutive days

2. A positive C. difficile stool test

3. The requirement of CDI standard-of-care antibiotic therapy (defined as 10 to 21
days of treatment with vancomycin or fidaxomicin but excluding pulse-tapered
antibiotic regimens).

4. An adequate clinical response defined as no evidence of diarrhea (< 3 unformed
stools in 24 hours) for 2 or more consecutive days before randomization.

5. If female, patient is non-lactating, and is either:

1. Not of childbearing potential, defined as postmenopausal for at least 1 year or
surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy.

2. Of childbearing potential and is practicing at least 1 highly effective method
of birth control including the barrier method; oral or parenteral
contraceptives; a vasectomized partner; or abstinence from sexual intercourse.
The investigator will discuss with the patient the option of practicing more
than 1 of the above methods for the duration of the study.

6. If male and partner is of childbearing potential, patient agrees to practice at least
1 highly effective method of birth control for the duration of the study.

7. Is not taking probiotics, or discontinues probiotics prior to study start and will
not take probiotics for the duration of the study.

Exclusion Criteria:

1. Female patients who are pregnant, breastfeeding, lactating, or planning to become
pregnant during the study.

2. Known or suspected toxic megacolon and/or known small bowel ileus.

3. Active irritable bowel syndrome with diarrhea within the previous 12 months.

4. Admitted to or expected to be admitted to an acute care facility or intensive care
unit for medical reasons (not just boarding). Patients discharged from an acute care
facility before Day 1 or residing in nursing homes or rehabilitation facilities may
be enrolled.

5. Taking antibacterial therapy other than vancomycin (non-tapered) or fidaxomicin for
most recent episode of CDI within 14 days before enrollment. A single-day antibiotic
prophylactic regimen is permitted.

6. Use of any probiotics.

7. Major gastrointestinal surgery (e.g., significant bowel resection or diversion)
within 3 months before enrollment (this does not include appendectomy or
cholecystectomy) or any history of total colectomy or bariatric surgery.

8. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease,
microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel
disease in the past 24 months.

9. Unable to stop loperamide, diphenoxylate/atropine, or cholestyramine before the
study.

10. Unable to stop opiate treatment unless on a stable dose, including PRN dosing, as of
onset of diarrhea and no increase in dose planned for the duration of the study.

11. Known positive stool cultures for other enteropathogens including, but not limited
to, Salmonella, Shigella, and Campylobacter within the 30 days before enrollment.

12. Known stool studies positive for ova and/or parasites within the 30 days before
enrollment.

13. Poor concurrent medical risks with clinically significant co-morbid disease such
that, in the opinion of the investigator, the patient should not be enrolled.

14. Received an investigational vaccine against C. difficile.

15. Known active intravenous drug or alcohol abuse or other drugs of abuse.
We found this trial at
27
sites
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Gail Hecht
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Mark Mulligan, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Elizabeth Hohmann, MD
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Bharat Misra
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
Principal Investigator: Ammar Hemaidan, MD
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Annapolis, Maryland 21401
Principal Investigator: James Welker
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Atlantis, Florida 33462
Principal Investigator: Debra L Weinstein, MD
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Baltimore, Maryland 21224
Principal Investigator: Jonathan Zenilman, MD
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Butte, Montana 59701
Principal Investigator: John Pullman, MD
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Chatfield, Minnesota 55905
Principal Investigator: Darrell Pardi, MD
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Chevy Chase, Maryland 20815
Principal Investigator: Robert Hardi, MD
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Cincinnati, Ohio 45267
Principal Investigator: Senu Apewokin
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Columbus, Ohio 43215
Principal Investigator: Ian Baird, MD, FACP
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Debary, Florida
Principal Investigator: Kwabena Ayesu, MD
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Englewood Cliffs, New Jersey 07632
Principal Investigator: Mitchell Spinnell, MD
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Houston, Texas 77030
Principal Investigator: Herbert DuPont, MD
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Idaho Falls, Idaho 83404
Principal Investigator: Richard Nathan, DO
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Lima, Ohio 45801
Principal Investigator: Ravi Kamepalli, MD,FIDSA,CWS
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Lynchburg, Virginia 24501
Principal Investigator: Robert Brennan, MD, FACS
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Napels, Florida 34102
Principal Investigator: Raymond Phillips, MD
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New Orleans, Louisiana 70121
Principal Investigator: Julia Garcia-Diaz, MD
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New York, New York 10029
Principal Investigator: Ari Grinspan, MD
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19107
Principal Investigator: Neilanjan Nandi, MD
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Royal Oak, Michigan 48073
Principal Investigator: Matthew Sims, MD, PhD
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Stuart Cohen, MD
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St. Louis, Missouri 63141
Principal Investigator: Leonard Weinstock, MD
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Ventura, California 93003
Principal Investigator: Sabine Hazan-Steinberg
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