Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody.

Conditions: Primary biliary cirrhosis
MedDRA version: 14.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-001326-26-GB

Lead Sponsor: ovImmune S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Male or female, 18 years or older
2. Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
- History of increased ALP levels for at least 6 months
- Positive serum AMA titer (>1:40)
- Liver biopsy consistent with PBC
3. Incomplete response to UDCA defined as failure to normalise ALP levels or to reduce ALP levels by more than 40% after 1 year of therapy with UDCA according to the local recommended dose.
4. Stable dose of UDCA for at least 6 months prior to screening
5. Screening ALP > 1.5 ULN
6. Screening ALT or AST > 1.5 ULN
7. Female patients must be postmenopausal, surgically sterile, or willing to use 2 methods of effective contraception with all sexual partners until 3 months after having received the last dose of study medication
8. Male patients who agree to take the appropriate precautions to avoid fathering a child until 3 months after having received the last dose of study medication
9. Have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Screening bilirubin > 2.9 mg/dL (50 µmol/L)
2. Screening creatinine clearance < 80 ml/min
3. History or presence of hepatic decompensation
4. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV), primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease (AIH) and biopsy proven nonalcoholic steatohepatitis (NASH)
5. Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
6. Average alcohol ingestion >21 units/week (male) / >14 units/week (female)
7. Have received any immunosuppressants, steroids or peroxisome proliferator activation receptor (PPAR) activators at any time during the 3 months prior to screening for the study
8. Known or previous diagnosis of malignancy
9. Presence of any active infection
10. Presence or history of multiple allergic reactions to drugs
11. Previous history of active TB within 12 months of screening
12. Pregnant or breastfeeding women
13. Have received or plan to receive any vaccines within 6 weeks prior to receiving study drug and throughout the study period

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of multiple doses of NI 0801 on hepatic function<br><br>;Secondary Objective: To evaluate the safety and tolerability of multiple doses of NI-0801 in primary biliary cirrhosis patients<br>To characterize the pharmacokinetic and pharmacodynamic profile of multiple doses of NI 0801 <br>To assess immunogenicity of NI 0801;Primary end point(s): Change in liver enzyme measurements from baseline to Week 12 (SD85);Timepoint(s) of evaluation of this end point: Week 12 (SD85)

Secondary Outcome Measures