OBINUTUZUMAB for Systemic lupus erythematosus

Inclusion criteria

• {"criterion_text":"- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria ≥12 weeks prior to screening\n- 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\n- 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\n- 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])\n- High disease activity on Day 1, based on; SLEDAI-2K (score ≥8) and PGA (score ≥1.0 on a 0 to 3 VAS)\n- 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"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breastfeeding\n- Presence of significant lupus-associated renal disease and/or renal impairment\n- 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\n- Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation\n- Known active infection of any kind or recent major episode of infection\n- Intolerance or contraindication to study therapies"}

Primary endpoints

• {"endpoint_text":"- 1. Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index (SRI)(4) at Week 52","definition_or_measurement_approach":"Measured as the proportion of participants who achieve the Systemic Lupus Erythematosus Responder Index (SRI)(4) at Week 52 as stated in the protocol/main objective."}

Secondary endpoints

• {"endpoint_text":"- 1. Proportion of participants who achieve SRI(6) at Week 52\n- 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\n- 3. Time to first BILAG flare over 52 weeks\n- 4. Proportion of participants who achieve Sustained SRI(4) response from Week 40 through Week 52\n- 5. Proportion of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52\n- 6. Proportion of participants who achieve SRI(4) at Week 24\n- 7. Proportion of participants who achieve clinical SRI(4) at Week 52\n- 8. Proportion of participants who achieve SRI(4) at Week 52 on low-dose corticosteroids\n- 9. Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 52\n- 10. Proportion of participants who achieve Definition of Remission in SLE (DORIS) at Week 52\n- 11. Change in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-F) scale from baseline to Week 24 and from baseline to Week 52\n- 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\n- 13. Change in SF-36 v2 Physical Component Summary scale from baseline to Week 24 and from baseline to Week 52\n- 14. Change in active joint count (swollen plus tender) from baseline to Week 24 and from baseline to Week 52\n- 15. Proportion of participants who achieve a ≥50% reduction in active joint counts (swollen plus tender) at each study visit\n- 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\n- 17. Proportion of participants who achieve sustained corticosteroid control from Week 40 through Week 52\n- 18. Cumulative corticosteroid use (in equivalent milligrams of prednisone) through Week 52\n- 19. Incidence and severity of adverse events\n- 20. Characterization of adverse events of special interest\n- 21. Change from baseline in targeted vital signs\n- 22. Change from baseline in targeted clinical laboratory test results\n- 23. Serum concentrations of obinutuzumab at specified timepoints\n- 24. Prevalence of ADAs at baseline and incidence of ADAs during the study","definition_or_measurement_approach":"Endpoints measured as specified in the protocol at the indicated timepoints (e.g., proportions at Week 52 or Week 24; time-to-event for BILAG flare over 52 weeks; changes from baseline for FACIT-F, SF-36, joint counts; PK serum concentrations at specified timepoints; incidence/characterization of adverse events and ADAs)."}

Czechia

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

22-03-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

21-03-2024

Processing Time Days

27

Number Of Sites

4

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

21-03-2024

Processing Time Days

27

Number Of Sites

6

Number Of Participants

12

Poland

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

25-03-2024

Processing Time Days

31

Number Of Sites

7

Number Of Participants

28

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

Global CRO

Name

IQVIA Limited

Responsibilities

Monitoring

Name

Parexel International Corp.

Name

Endpoint Clinical Inc.

Third parties

• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"other","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Meeting Organizer","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Covance Central Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"other","organisation_type":"Non-Pharmaceutical company"}