Systemic Sclerosis MedDRA version: 14.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: paquinimod
Product Code: ABR-215757
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: paquinimod
CAS Number: 248282-01-1
Current Sponsor code: ABR-215757
Concentration unit: mg mil
Sponsors
Active Biotech AB
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757;Secondary Objective: To assess the safety and tolerability of ABR-215757 in progressive SSc patients To assess disease activity and quality of life (QoL) in patients with progressive SSc during treatment with ABR-215757 To assess the plasma levels of ABR-215757 during the study ;Primary end point(s): • Changes in SSc disease activity related biomarkers;Timepoint(s) of evaluation of this end point: baseline, 2, 4 and 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adverse events and changes in laboratory safety parameters. • Disease activity • Quality of life measured by the SF-36 health survey and by the scleroderma health assessment questionnaire (SHAQ) • Plasma levels of ABR-215757 ;Timepoint(s) of evaluation of this end point: baseline, 2, 4 and 8 weeks of treatment (In the open label continuation, safety and disease activity will be evaluated every 12 weeks) | — |
Countries
Germany, Sweden, Switzerland
Contacts
Public ContactClinical Trials at Active Biotech
Active Biotech AB
Outcome results
None listed