- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487551
An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Berlin, Germany
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Cologne, Germany
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Erlangen, Germany
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Gothenburg, Sweden
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Lund, Sweden
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Zürich, Switzerland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: paquinimod
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Hard gelatine capsules 3.0 mg/day for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Biomarkers
Time Frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.
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Changes in SSc disease activity related biomarkers
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Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roger Hesselstrand, MD, Dept of Rheumatology, University Hospital in Lund, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11575705
- 2011-001667-44 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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