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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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Charles Landis
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185 Cambridge Street
Boston, Massachusetts 02114
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Alan Bonder
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Atlanta, Georgia
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345 Saint Paul Place
Baltimore, Maryland 21202
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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
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Clearwater, Florida 33756
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Coronado, California 92118
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Dallas, Texas 75203
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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
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Houston, Texas 77030
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Inverness, Florida 34452
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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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
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Mary Drinane
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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 10016
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1428 Madison Ave
New York, New York 10029
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Omaha, Nebraska 68124
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San Antonio, Texas 78215
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Phone: 210-253-3426
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45 Castro Street
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Seattle, Washington 98122
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Shreveport, Louisiana 71103
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