A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus (ALLEGORY)
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Registration Number
- 2023-504774-38-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve systemic lupus erythematosus responder index (SRI) (4)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 68
Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria ≥12 weeks prior to screening
Anti-nuclear antibody (ANA) ≥1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening Low C3 is required in the presence of known genetic deficiency of C4
High disease activity at screening, based on; British Isles Lupus Assessment Group (BILAG-2004) (Category A disease in ≥1 organ system and/or Category B disease in ≥2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score ≥8) and Physician’s Global Assessment (PGA) (score ≥1.0 on a 0 to 3 visual analogue scale [VAS])
High disease activity on Day 1, based on; SLEDAI-2K (score ≥8) and PGA (score ≥1.0 on a 0 to 3 VAS)
Current receipt of ≥1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
Pregnancy or breastfeeding
Presence of significant lupus-associated renal disease and/or renal impairment
Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
Known active infection of any kind or recent major episode of infection
Intolerance or contraindication to study therapies
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index (SRI)(4) at Week 52 1. Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index (SRI)(4) at Week 52
- Secondary Outcome Measures
Name Time Method 1. Proportion of participants who achieve SRI(6) at Week 52 1. Proportion of participants who achieve SRI(6) at Week 52
2. Proportion of participants entering the study on prednisone ≥ 10 mg/day (or equivalent) who achieve Sustained Corticosteroid Control from Week 40 through Week 52 2. Proportion of participants entering the study on prednisone ≥ 10 mg/day (or equivalent) who achieve Sustained Corticosteroid Control from Week 40 through Week 52
3. Time to first BILAG flare over 52 weeks 3. Time to first BILAG flare over 52 weeks
4. Proportion of participants who achieve Sustained SRI(4) response from Week 40 through Week 52 4. Proportion of participants who achieve Sustained SRI(4) response from Week 40 through Week 52
5. Proportion of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52 5. Proportion of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
6. Proportion of participants who achieve SRI(4) at Week 24 6. Proportion of participants who achieve SRI(4) at Week 24
7. Proportion of participants who achieve clinical SRI(4) at Week 52 7. Proportion of participants who achieve clinical SRI(4) at Week 52
8. Proportion of participants who achieve SRI(4) at Week 52 on low-dose corticosteroids 8. Proportion of participants who achieve SRI(4) at Week 52 on low-dose corticosteroids
9. Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 52 9. Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 52
10. Proportion of participants who achieve Definition of Remission in SLE (DORIS) at Week 52 10. Proportion of participants who achieve Definition of Remission in SLE (DORIS) at Week 52
11. Change in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-F) scale from baseline to Week 24 and from baseline to Week 52 11. Change in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-F) scale from baseline to Week 24 and from baseline to Week 52
12. Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain domain scale from baseline to Week 24 and from baseline to Week 52 12. Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain domain scale from baseline to Week 24 and from baseline to Week 52
13. Change in SF-36 v2 Physical Component Summary scale from baseline to Week 24 and from baseline to Week 52 13. Change in SF-36 v2 Physical Component Summary scale from baseline to Week 24 and from baseline to Week 52
14. Change in active joint count (swollen plus tender) from baseline to Week 24 and from baseline to Week 52 14. Change in active joint count (swollen plus tender) from baseline to Week 24 and from baseline to Week 52
15. Proportion of participants who achieve a ≥50% reduction in active joint counts (swollen plus tender) at each study visit 15. Proportion of participants who achieve a ≥50% reduction in active joint counts (swollen plus tender) at each study visit
16. Proportion of participants who achieve a ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each study visit, among Participants with CLASI Total Activity Score ≥10 at Baseline 16. Proportion of participants who achieve a ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each study visit, among Participants with CLASI Total Activity Score ≥10 at Baseline
17. Proportion of participants who achieve sustained corticosteroid control from Week 40 through Week 52 17. Proportion of participants who achieve sustained corticosteroid control from Week 40 through Week 52
18. Cumulative corticosteroid use (in equivalent milligrams of prednisone) through Week 52 18. Cumulative corticosteroid use (in equivalent milligrams of prednisone) through Week 52
19. Incidence and severity of adverse events 19. Incidence and severity of adverse events
20. Characterization of adverse events of special interest 20. Characterization of adverse events of special interest
21. Change from baseline in targeted vital signs 21. Change from baseline in targeted vital signs
22. Change from baseline in targeted clinical laboratory test results 22. Change from baseline in targeted clinical laboratory test results
23. Serum concentrations of obinutuzumab at specified timepoints 23. Serum concentrations of obinutuzumab at specified timepoints
24. Prevalence of ADAs at baseline and incidence of ADAs during the study 24. Prevalence of ADAs at baseline and incidence of ADAs during the study
Trial Locations
- Locations (23)
Revmatologicky Ustav
🇨🇿Prague 2, Czechia
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷Brest, France
Assistance Publique Hopitaux De Paris
🇫🇷Paris Cedex 13, France
Centre Hospitalier Universitaire De Nice
🇫🇷Nice, France
Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario De Vigo
🇪🇸Vigo, Spain
Complexo Hospitalario Universitario De Santiago
🇪🇸Santiago De Compostela, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Basurto
🇪🇸Bilbao, Spain
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Scroll for more (13 remaining)Revmatologicky Ustav🇨🇿Prague 2, CzechiaSarka ForejtovaSite contact+420234075102forejtova@revma.cz