Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis

Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001219-30-CZ

Enrollment

216

Registered

2011-06-20

Start date

2011-08-18

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapse of Wegener’s Granulomatosis MedDRA version: 13.1 Level: PT Classification code 10047888 Term: Wegener's granulomatosis System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1 Level: LLT Classification code 10047889 Term: Wegeners granulomatosis System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Gusperimus Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: gusperimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Documented diagnosis of WG according to the ACR classification criteria. 2. Diagnosis of WG at least 6 months before entry and initial induction therapy with a combination of GC and an immunosuppressive (CYC or MTX) or rituximab. 3. Relapse of WG with or without ongoing GC, and/or immunosuppressive therapy with AZA/MMF/MTX or LEF. The minimum disease activity is defined by the presence of one new/worse major or three new/worse minor BVAS (version 3) items. 4. Patients between 18 – 75 years. 5. Medically acceptable and reliable contraception method during the study course. (Women should not become pregnant for at least 6 months after CYC treatment). 6. Written informed consent for study participation given by the patient. 7. Patients able and prepared to self-administer the study medication or having a relative/third person able to do it. 8. Ability to read, understand and record information required by protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Other multi-system autoimmune disorders, including systemic lupus erythematosus and anti-GBM disease. 2. Systemic vasculitis due to a viral infection. 3. CYC therapy intolerance, hypersensitivity or contraindication to CYC (active substance or any of the excipients) in patients with severe relapse of WG. 4. Hypersensitivity or contraindication to - Spanidin (active substance or any of the excipients) or - both MTX (active substance or any of the excipients) and AZA (active substance or any of the excipients) or - methylprednisolone, prednisolone or other corticosteroids (active substance or any of the excipients). 5. Underlying medical conditions, which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study. 6. Previous randomisation in this study. 7. CYC, intravenous immunoglobulin, anti-cytokine biologic therapies, plasma exchange or Abatacept in the three months prior to entry to the trial. Rituximab, Alemtuzumab or stem cell transplantation is not permitted in the six months prior to entry to the trial. 8. Previous treatment with gusperimus. 9. Participation in another clinical trial with investigational drugs within the last 3 months before screening or during the present trial period. 10. Pregnant or breast-feeding females. 11. Active bacterial/viral infection (HIV, Hepatitis B, Hepatitis C, Tuberculosis). 12. Patients with eGFR < 15 mL/min/1.73m2 (MDRD equation). 13. ALT, AST, bilirubin, and ALP levels above 2 x the upper normal limit. 14. Inadequate bone-marrow function: WBC < 4000/mm3, haemoglobin < 8 g/dL, neutrophils < 2500/mm3, platelets < 100 000/mm3.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of WG with or without ongoing steroids, and/or immunosuppressive therapy (AZA/MMF/MTX or LEF). ;Secondary Objective: To evaluate the safety and quality of life of gusperimus treatment compared to standard treatment in patients with relapse of WG receiving GC The pharmacokinetic parameters - to examine the pharmacokinetics of s.c. gusperimus in this patient population - to assess inter- and intra- subject variability in gusperimus pharmacokinetics following chronic s.c. administration. ;Primary end point(s): The primary efficacy variable is the rate of patients showing, within 24 weeks of trial entry, response with the level of disease activity BVAS = 2 that is maintained without relapse until the end of the trial (Week 52).;Timepoint(s) of evaluation of this end point: Achievement of BVAS = 2 within 24 weeks Maintenance of BVAS = 2 until the end of 52nd week	—

Measure

Time frame

Main Objective: The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of WG with or without ongoing steroids, and/or immunosuppressive therapy (AZA/MMF/MTX or LEF). ;Secondary Objective: To evaluate the safety and quality of life of gusperimus treatment compared to standard treatment in patients with relapse of WG receiving GC The pharmacokinetic parameters - to examine the pharmacokinetics of s.c. gusperimus in this patient population - to assess inter- and intra- subject variability in gusperimus pharmacokinetics following chronic s.c. administration. ;Primary end point(s): The primary efficacy variable is the rate of patients showing, within 24 weeks of trial entry, response with the level of disease activity BVAS = 2 that is maintained without relapse until the end of the trial (Week 52).;Timepoint(s) of evaluation of this end point: Achievement of BVAS = 2 within 24 weeks Maintenance of BVAS = 2 until the end of 52nd week

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Secondary

Measure	Time frame
Secondary end point(s): - Time to response (response is defined as the time from study entry to the first occasion that BVAS is = 2, and there has been adherence to the steroid reduction protocol). - Response duration defined as time from response with BVAS=2 to relapse (relapse is defined as the return or first occurrence of one major and/or three minor BVAS items). - Frequency of severe relapses (defined as at least one major BVAS item). - Frequency of non-severe relapses (defined as at least 3 minor BVAS items with no major BVAS items). - VDI score change from baseline to month 12. - eGFR change from baseline to month 12 in all patients and in a subgroup defined as having a baseline eGFR = 60mL/min (i.e. renal impairment at baseline). - Frequency of AEs and SAEs. (Total number of AEs per group according to AE category) (Percentage of patients in each group with a severe AE). - Frequency of severe infection (a severe infection is defined as an infection that requires intravenous antibiotics or hospitalisation).(Percentage of patients in each group with a severe infection). - Pharmacokinetic parameters AUC, Cmax, Tmax and T½ calculated from the measured plasma samples collected at regular time intervals after administration of gusperimus on the first day of three treatment cycles. - Pooled physical and mental SF 36 domains change from baseline to month 6. - Pooled physical and mental SF 36 domains change from baseline to month 12. - The total corticosteroid exposure. - Change in EQ5D between baseline and month 12. ;Timepoint(s) of evaluation of this end point: please see E.5.2	—

Measure

Time frame

Secondary end point(s): - Time to response (response is defined as the time from study entry to the first occasion that BVAS is = 2, and there has been adherence to the steroid reduction protocol). - Response duration defined as time from response with BVAS=2 to relapse (relapse is defined as the return or first occurrence of one major and/or three minor BVAS items). - Frequency of severe relapses (defined as at least one major BVAS item). - Frequency of non-severe relapses (defined as at least 3 minor BVAS items with no major BVAS items). - VDI score change from baseline to month 12. - eGFR change from baseline to month 12 in all patients and in a subgroup defined as having a baseline eGFR = 60mL/min (i.e. renal impairment at baseline). - Frequency of AEs and SAEs. (Total number of AEs per group according to AE category) (Percentage of patients in each group with a severe AE). - Frequency of severe infection (a severe infection is defined as an infection that requires intravenous antibiotics or hospitalisation).(Percentage of patients in each group with a severe infection). - Pharmacokinetic parameters AUC, Cmax, Tmax and T½ calculated from the measured plasma samples collected at regular time intervals after administration of gusperimus on the first day of three treatment cycles. - Pooled physical and mental SF 36 domains change from baseline to month 6. - Pooled physical and mental SF 36 domains change from baseline to month 12. - The total corticosteroid exposure. - Change in EQ5D between baseline and month 12. ;Timepoint(s) of evaluation of this end point: please see E.5.2

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Countries

Czech Republic, France, Germany, Italy, Netherlands, Russian Federation, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

Public Contactclinical department

Prague Clinical Services, s.r.o.

info@pragclin.com+420241029542

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026