An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

Active Biotech AB0 sites9 target enrollmentDecember 2011

ConditionsSystemic Sclerosis

Interventionspaquinimod

Drugspaquinimod

Overview

Phase: Phase 2
Intervention: paquinimod
Conditions: Systemic Sclerosis
Sponsor: Active Biotech AB
Enrollment: 9
Primary Endpoint: Biomarkers
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective is to study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757.

The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the plasma levels of ABR-215757 during the study.

Detailed Description

This is an open label single arm Phase II study in patients with progressive SSc. Patients will be treated with ABR-215757 for 8 weeks. Assessment of biomarkers, disease activity and safety parameters will be performed during treatment. Patients will be offered to continue in an open label extension.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

February 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Active Biotech AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years at the time of signing the informed consent form
•Clinical Diagnosis of SSc according to ACR criteria
•Progressive SSc fulfilling at least one of the following:
•STPR (Skin Thickness Progression Rate) ≥ 40, calculated as the mRSS at screening divided by time (in years) since the start of skin involvement. as reported by the patient (Denton 2007)
•Worsening of mRSS within the last 6 months as judged by the physician together with the patient, with involvement of at least two new anatomical sites as defined in the mRSS score (e.g. upper arm and thorax) or progression by at least two points in at least two anatomical sites as defined by the mRSS
•Presence of SSc skin lesions on one or both forearms
•Modified Rodnan Skin score (mRSS) ≥16 at baseline
•ANA-positive

Exclusion Criteria

•Ongoing Severe SSc manifestations, such as pulmonary arterial hypertension (PAH) with dyspnea NYHA III or more, scleroderma renal crisis
•Vital capacity \< 60% as measured within 6 months prior to the first dose of study medication
•GFR \< 30% of normal measured within 6 months prior to the first dose of study medication
•Treatment with Rituximab within 12 months or other biologic agent within 6 months, Mycophenolate mofetil (MMF) or Cyclophosphamide within 6 months, Methotrexate, Azathioprine or other immunosuppressants within 3 months prior to the first dose of study medication
•History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia.
•Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>450 milliseconds
•History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome)
•Treatment with concomitant medications that prolong the QT interval.
•History of, or current ischemic CNS disease
•Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised