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

NCT01487551 | Completed Phase 2

• 2 other identifiers: 115757052011-001667-44
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 6

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 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.

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Biomarkers

  Changes in SSc disease activity related biomarkers

  Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.

Study Arms (1)

paquinimod

EXPERIMENTAL

Drug: paquinimod

Interventions

paquinimod DRUG

Hard gelatine capsules 3.0 mg/day for 8 weeks

paquinimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Active Biotech AB: lead

Study Sites (6)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

• Hesselstrand R, Distler JHW, Riemekasten G, Wuttge DM, Torngren M, Nyhlen HC, Andersson F, Eriksson H, Sparre B, Tuvesson H, Distler O. An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with paquinimod. Arthritis Res Ther. 2021 Jul 31;23(1):204. doi: 10.1186/s13075-021-02573-0.

  PMID: 34330322 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

paquinimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Roger Hesselstrand, MD

  Dept of Rheumatology, University Hospital in Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

DE (3); CH (1); SE (2)