Status:
COMPLETED
An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
Lead Sponsor:
Active Biotech AB
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tolera...
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...
Eligibility Criteria
Inclusion
- 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
- 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
- Current severe infection
- Known positive serology for HIV or active or latent hepatitis infection.
- Treatment with endothelin receptor antagonist within 6 weeks prior to the first dose of study medication
- Drug abuse
- Major surgery within 3 weeks prior to study entry
- Known or suspected hypersensitivity to ABR-215757 or excipients
- Female patient of child-bearing potential who is not using a medically accepted safe method of contraception. All female patients of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and hormonal contraceptives have not yet been performed, women using hormonal contraceptives such as the contraceptive pill, must also use a complementary contraceptive device, i.e. barrier method, during the treatment period and for at least 1 month thereafter
- Female patient of child-bearing potential who is pregnant or lactating.
- Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy.
- Other significant, unstable medical disease not related to SSc that in the investigator's opinion would confound the study result or put the patient at risk
- Patients likely to receive oral or intravenous steroids or immunosuppressant for other non-SSc condition during the study duration, as this will confound the study result.
- Vaccination within 4 weeks prior to the first dose of study medication. Study Drug(s): ABR-215757
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01487551
Start Date
December 1 2011
End Date
February 1 2013
Last Update
August 27 2014
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Berlin, Germany
2
Cologne, Germany
3
Erlangen, Germany
4
Gothenburg, Sweden