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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Active Biotech AB
ClinicalTrials.gov Identifier:
NCT01487551
First received: December 6, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Systemic Sclerosis
Drug: paquinimod
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

Resource links provided by NLM:


Further study details as provided by Active Biotech AB:

Primary Outcome Measures:
  • Biomarkers [ Time Frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment. ] [ Designated as safety issue: No ]
    Changes in SSc disease activity related biomarkers


Enrollment: 9
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paquinimod Drug: paquinimod
Hard gelatine capsules 3.0 mg/day for 8 weeks
Other Name: paquinimod

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487551

Locations
Germany
Berlin, Germany
Cologne, Germany
Erlangen, Germany
Sweden
Gothenburg, Sweden
Lund, Sweden
Switzerland
Zürich, Switzerland
Sponsors and Collaborators
Active Biotech AB
Investigators
Principal Investigator: Roger Hesselstrand, MD Dept of Rheumatology, University Hospital in Lund, Sweden
  More Information

No publications provided

Responsible Party: Active Biotech AB
ClinicalTrials.gov Identifier: NCT01487551     History of Changes
Other Study ID Numbers: 11575705, 2011-001667-44
Study First Received: December 6, 2011
Last Updated: August 26, 2014
Health Authority: Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by Active Biotech AB:
Systemic sclerosis
Biomarkers

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014