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

Conditions: 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 Patient should be on incomplete response to UDCA
MedDRA version: 14.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-001326-26-IT

Lead Sponsor: OVIMMUNE BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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 10. Patients must be able to adhere to the study visits and protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Screening bilirubin > 2.9 mg/dL (50 µmol/L) • Screening creatinine clearance < 80 ml/min • History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites) • Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C • Known or previous diagnosis of malignancy • Presence of any active infection • Previous history of active TB within 12 months of screening

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;Secondary Objective: •To evaluate the safety and tolerability of multiple doses of NI-0801 in PBC patients •To characterize the pharmacokinetic and pharmacodynamic profile of multiple doses 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