Clinical trial NCT01487551 (phase 2, status: completed)
Conditions: systemic sclerosis
ICD codes: M34.0, M34.89, M34.9, M34.82, M34.83, M34.81, M34.2
Drugs: paquinimod
SMILES: CCN(C(=O)C1=C(O)C2=C(CC)C=CC=C2N(C)C1=O)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years at the time of signing the informed consent form

          2. Clinical Diagnosis of SSc according to ACR criteria

          3. 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

          4. Presence of SSc skin lesions on one or both forearms

          5. Modified Rodnan Skin score (mRSS) ≥16 at baseline

          6. ANA-positive

        Exclusion Criteria:

          1. Ongoing Severe SSc manifestations, such as pulmonary arterial hypertension (PAH) with
             dyspnea NYHA III or more, scleroderma renal crisis

          2. Vital capacity < 60% as measured within 6 months prior to the first dose of study
             medication

          3. GFR < 30% of normal measured within 6 months prior to the first dose of study
             medication

          4. 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

          5. 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.

          6. Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc
             interval >450 milliseconds

          7. History of additional risk factors for torsade de pointes (eg, heart failure,
             hypokalemia, family history of long QT syndrome)

          8. Treatment with concomitant medications that prolong the QT interval.

          9. History of, or current ischemic CNS disease

         10. 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

         11. Current severe infection

         12. Known positive serology for HIV or active or latent hepatitis infection.

         13. Treatment with endothelin receptor antagonist within 6 weeks prior to the first dose
             of study medication

         14. Drug abuse

         15. Major surgery within 3 weeks prior to study entry

         16. Known or suspected hypersensitivity to ABR-215757 or excipients

         17. 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

         18. Female patient of child-bearing potential who is pregnant or lactating.

         19. 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.

         20. 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

         21. 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.

         22. Vaccination within 4 weeks prior to the first dose of study medication. Study Drug(s):
             ABR-215757