Systemic SclerosisPhase 2NCT01487551
An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
A Phase 2 study testing paquinimod in people with Systemic Sclerosis, run by Active Biotech AB at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- paquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Dec 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
About this study
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- paquinimod
- Keywords
- Systemic sclerosis, Biomarkers
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paquinimodDrug
Hard gelatine capsules 3.0 mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| paquinimod | Experimental | Not described Receives: Drug: paquinimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers
Changes in SSc disease activity related biomarkers
Measured: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Active Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Hesselstrand, MD, Principal investigator, Dept of Rheumatology, University Hospital in Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487551
- Sponsor's protocol ID
- 11575705
- Other IDs
- 2011-001667-44
- Status last verified
- Aug 2014
- First submitted
- 6 Dec 2011
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34330322
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
- ClinicalTrials.gov ID
- NCT01487551
- Acronym / sponsor ID
- 11575705
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Active Biotech ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paquinimod | Experimental | Drug: paquinimod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Presence of SSc skin lesions on one or both forearms
- Modified Rodnan Skin score (mRSS) ≥16 at baseline
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paquinimodHard gelatine capsules 3.0 mg/day for 8 weeks | Drug | paquinimod |
Primary outcome
Biomarkers
Time frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.
Changes in SSc disease activity related biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
- Derived from this study: PubMed 34330322Hesselstrand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Hesselstrand, MD principal investigator
Dept of Rheumatology, University Hospital in Lund, Sweden
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paquinimod in people with Systemic Sclerosis, run by Active Biotech AB at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Sweden, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers (time frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.