A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/22/2019
Start Date:December 27, 2017
End Date:April 2019
Contact:Nathalie Adda
Email:nadda@enanta.com
Phone:617 607 0705

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A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of
EDP-305 in subjects with primary biliary cholangitis


Inclusion Criteria:

- An informed consent document signed and dated by the subject.

- Male and female subjects of any ethnic origin between the ages of 18 and 75 years,
inclusive

- Male or female with a diagnosis of PBC by at least two of the following criteria:

- History of ALP above ULN for at least six months

- Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence
or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive
PBC-specific antinuclear antibodies)

- For subjects with no documented liver biopsy performed within 2 years, subjects must
undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA

- Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to
Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at
least 12 weeks prior to Screening)

- Alkaline Phosphatase (ALP) ≥ 1.67 × ULN and/or total bilirubin >ULN but < 2×ULN (<2.4
mg/dL)

- Subjects must have Screening laboratory values for Hepatitis B surface antigen
(HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus
(HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by
chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained
virologic response (SVR) for at least 3 years will be allowed.

- Female subjects of childbearing potential must agree to use two effective methods of
contraception from the date of Screening until 90 days after the last dose of EDP-305.

- All male participants who have not had a vasectomy must use effective contraception
from Day -1 to 90 days after their last dose of study drug.

- Male subjects must agree to refrain from sperm donation from the date of Screening
until 90 days after their last dose of study drug

- Screening body mass index (BMI) of ≥18 kg/m2

- Subject must be willing and able to adhere to the assessments, visit schedule,
prohibitions and restrictions, as described in this protocol

Exclusion Criteria:

- Laboratory Screening Results:

- AST >5 x ULN

- ALT >5 x ULN

- Patients with Gilbert's syndrome will not be allowed due to interpretability of
bilirubin levels

- Total white blood cells (WBC) <3000 cells/mm3

- Absolute neutrophil count (ANC) <1500 cells/mm3

- Platelet count <140,000/mm3

- Prothrombin time (international normalized ratio, INR) >1.2

- Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on
Cockroft-Gault Method)

- Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the
judgment of the Investigator at Screening

- Use of immunosuppressants known to have an effect on the liver of patients with PBC
(eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months
preceding screening

- Current use of fibrates, including fenofibrates. Note: Subjects who discontinued
fibrates for at least 3 months before Screening can participate

- Use of an experimental treatment for PBC within the past 6 months

- Co-existing liver or biliary diseases, such as primary sclerosing cholangitis,
choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver
disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or
gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension),
cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers

- Cirrhosis with or without complications, including history or presence of: spontaneous
bacterial peritonitis, hepatocellular carcinoma

- Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178
μmol/L)

- Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C,
esophageal varices, or refractory ascites within the previous 6 months of Screening
(defined as date informed consent signed)

- Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)

- Use of a new statin regimen from Screening and throughout study duration. NOTE:
Subjects on a stable dose of statins for at least 3 months prior to Screening are
allowed. No dose modification during the study will be allowed.

- Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive
weeks in duration within 1 year prior to Screening.
We found this trial at
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Mordechai Rabinovitz
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185 Cambridge Street
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617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Alan Bonder
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Seattle, Washington 98104
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Principal Investigator: Charles Landis
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Atlanta, Georgia
Principal Investigator: Gary Richter
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345 Saint Paul Place
Baltimore, Maryland 21202
Principal Investigator: Paul Thuluvath
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Bronx, New York 10467
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Catonsville, Maryland 21228
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Steven Flamm
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Clearwater, Florida 33756
Principal Investigator: Lawrence Michael Weiss
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Coronado, California 92118
Principal Investigator: Tarek Hassanein
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Dallas, Texas 75203
Principal Investigator: Maisha Barnes
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Dallas, Texas 76104
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Reena Salgia
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Dothan, Alabama 36305
Principal Investigator: Scott Sarrels
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Houston, Texas 77030
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Inverness, Florida 34452
Principal Investigator: Paul Hellstern
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Antonio Sanchez
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kingswood, New South Wales 2747
Principal Investigator: Martin Weltman
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Mary Drinane
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Little Rock, Arkansas 72205
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Little Rock, Arkansas 76012
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Manhasset, New York 11030
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Miami, Florida 33136
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New York, New York 10016
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New York, New York 10021
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New York, New York 10016
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1428 Madison Ave
New York, New York 10029
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Principal Investigator: Douglas Dieterich
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Omaha, Nebraska 68124
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Pasadena, California 91105
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301 South Fair Oaks Avenue
Pasadena, California 91105
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Rialto, California 92377
Principal Investigator: Zeid Kayali, MD
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Richmond, Virginia 23602
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San Antonio, Texas 78215
Principal Investigator: Eric Lawitz, MD
Phone: 210-253-3426
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45 Castro Street
San Francisco, California 94114
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Seattle, Washington 98122
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Shreveport, Louisiana 71103
Principal Investigator: Humberto Aguilar
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