The BeLimumab Antiphospholipid Syndrome Trial (BLAST)

NCT05020782 | Unknown Phase 2

• 1 other identifier: APSGB01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antiphospholipid Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events

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

  104 weeks

Secondary Outcomes (6)

• The Efficacy of Belimumab-thrombocytopenia

  104 weeks

• The Efficacy of Belimumab-CVD

  104 weeks

• The Efficacy of Belimumab-renal involvement

  104 weeks

• The Efficacy of Belimumab-cognitive impairment

  104 weeks

• The Efficacy of Belimumab-thrombosis

  104 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

INTERVENTION DRUG: BELIMUMAB 10 MG/KG

Drug: Belimumab

Interventions

Belimumab DRUG

INTERVENTION DRUG: BELIMUMAB 10 MG/KG

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Cardiac valve disease and/or
• Chronic skin ulcers and/or
• Renal thrombotic microangiopathy and/or
• Cognitive dysfunction with/without white matter changes

You may not qualify if:

• \>=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
• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

San Giovanni Bosco Hospital

Turin, Piedmont, 10154, Italy

RECRUITING

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

belimumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 25, 2021
• Study Start: June 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 13, 2023

Record last verified: 2022-05

Locations

IT (1)