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Antiphospholipid SyndromePhase 2/3BLASTNCT05020782

The BeLimumab Antiphospholipid Syndrome Trial (BLAST)

A Phase 2/3 study testing Belimumab in people with Antiphospholipid Syndrome, run by University of Turin, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

AIM: The primary objective of the BeLimumab Antiphospholipid Syndrome Trial (BLAST) is to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Antiphospholipid Syndrome
What is being tested?
Belimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
1 Jun 2022to 1 Jan 2025
Phase
Phase 2/3
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Positive aPL profile defined as: Positive lupus anticoagulant test as defined by the International Society on Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart and/or Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart and/or Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart
  • AND
  • Clinical features attributable to aPL that are resistant to warfarin and/or heparin:
  • Recurrent thrombosis despite ongoing anticoagulation and/or
  • Persistent thrombocytopenia and/or
  • Persistent autoimmune hemolytic anemia and/or
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  • Cardiac valve disease and/or
  • Chronic skin ulcers and/or
  • Renal thrombotic microangiopathy and/or
  • Cognitive dysfunction with/without white matter changes

Who cannot join

  • >=4/11 American College of Rheumatology Classification Criteria for SLE
  • Acute thrombosis (arterial or venous acute thrombosis diagnosis less than 30 days before study screening)
  • History of stroke Acute or chronic pancreatitis
  • Pregnancy
  • Have a history of malignant neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years
  • Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk
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  • Have a history of a primary immunodeficiency
  • Have a significant IgG deficiency (IgG level < 400 mg/dL)
  • Have an IgA deficiency (IgA level < 10 mg/dL)
  • Known active bacterial, viral fungal mycobacterial, or other infection
  • Infection history:
  • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
  • Hospitalization for treatment of infection within 60 days of Day 0.
  • Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or antiparasitic agents) within 60 days of Day 0
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0
  • Have a historically positive HIV test or test positive at screening for HIV
  • Hepatitis status:
  • Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:
  • Patients positive for HBsAg or HBcAb are excluded
  • Positive test for Hepatitis C antibody
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
  • Have any other clinically significant abnormal laboratory value in the opinion of the investigator
  • If Women of Child-Bearing Potential (WCBP) are included, please see special instructions below.
  • Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • San Giovanni Bosco Hospital

    Turin, Piedmont, 10154

    Savino Sciascia, MD;PhD, +390112402051, savino.sciascia@unito.it

    Recruiting

Other trials in Italy

About this study

Official title: Open-label, Prospective, Phase II Descriptive Pilot Trial of Belimumab Therapy for Refractory and/or Non-criteria Manifestations of Antiphospholipid Syndrome

AIM: The primary objective of the BeLimumab Antiphospholipid Syndrome Trial (BLAST) is to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin.

Being tested
Belimumab
Medical subject headings
Antiphospholipid Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelimumabDrug

    INTERVENTION DRUG: BELIMUMAB 10 MG/KG

Study groups in NCT05020782
Study groupRoleWhat they receive
Intervention ArmExperimentalINTERVENTION DRUG: BELIMUMAB 10 MG/KG
Receives: Drug: Belimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Adverse Events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 104 weeks

Secondary outcomes (6)

  1. The Efficacy of Belimumab-thrombocytopenia

    Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For thrombocytopenia, CR defined as a platelet count of ≥150×109/μl,PR as 100-149,and NR as <100.

    Measured: 104 weeks

  2. The Efficacy of Belimumab-CVD

    Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks.For CVD,CR defined as the disappearance of cardiac lesions, PR as 50%improvement,and NR as no change.

    Measured: 104 weeks

  3. The Efficacy of Belimumab-renal involvement

    Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For aPL nephropathy, CR defined as a normal serum creatinine level, inactive urinary sediment, and urinary protein: creatinine 0.5;PR as a serum cr level 15% above baseline, RBCs per high-power field 50% above baseline with no casts, 50%improvement in the urinary prt:cr, and estimated GFR 10%above baseline; and NR as the absence of C/PR.

    Measured: 104 weeks

  4. The Efficacy of Belimumab-cognitive impairment

    Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%, and NR as no change.

    Measured: 104 weeks

  5. The Efficacy of Belimumab-thrombosis

    Rate of documented thrombotic events

    Measured: 104 weeks

  6. Change in aPL profile

    Change in aPL levels at 24, 52, 104 weeks

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start1 Jun 2022
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020782
Sponsor's protocol ID
APSGB01
Acronym
BLAST
Status last verified
May 2022
First submitted
29 Jul 2021
Last updated
13 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Belimumab in people with Antiphospholipid Syndrome, run by University of Turin, Italy at 1 site in Italy.

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 10 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events (time frame: 104 weeks). 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 NCT05020782.

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 13 Jan 2023.

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