Skip to content
DataLookout
Start free
Menu

ALLEGORYNCT04963296

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

StatusActive, Not Recruiting
PhasePhase 3
Primary completion

At risk: Primary endpoint(s) modified.

See at-risk trials from Roche/Genentech

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

The 50 most recent of 57 versions: 49 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 12, 2026 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 15 words
    • Study sites: 64 to 63
    • Interventions: Acetaminophen/Paracetamol (Drug), Diphenhydramine hydrochloride (Drug), Methylprednisolone (Drug), Obinutuzumab (Drug), Placebo (Drug) to Acetaminophen/Paracetamol (Drug), Diphenhydramine hydrochloride (Drug), Methylprednisolone (Drug), Obinutuzumab (Drug), Placebo (Drug)
    • Secondary endpoints revised (25)
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Mar 14, 2028 to Mar 13, 2028v56
  3. Study sites: 66 to 64v54
  4. Enrollment target: estimated 300 to confirmed 303
    • Study completion date: Sep 13, 2027 to Mar 14, 2028
    • Study sites revised (66)
    v53
  5. Study sites: 70 to 66
    • Primary completion date: Sep 16, 2025 to Sep 15, 2025
    v52
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites: 74 to 70
    • Primary completion date: Nov 30, 2025 to Sep 16, 2025
    • Study completion date: Nov 30, 2027 to Sep 13, 2027
    v51
  2. Study sites: 83 to 74v50
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 105 to 83
    v49
  4. Site details revised at 22 of 105 sitesv48
  5. Site details revised at 15 of 105 sitesv47
  6. Site details revised at 5 of 105 sitesv46
  7. Site details revised at 5 of 105 sitesv45
  8. Study sites: 104 to 105v44
  9. Site details revised at 6 of 104 sitesv43
  10. Site details revised at 6 of 104 sitesv42
  11. Site details revised at 4 of 104 sitesv41
  12. Site details revised at 8 of 104 sitesv40
  13. Study sites: 103 to 104v39
  14. Study sites revised (103)v38
  15. Site details revised at 8 of 103 sitesv37
  16. Study sites: 99 to 103v36
  17. Site details revised at 7 of 99 sitesv35
  18. Eligibility criteria expanded, about 15 words
    • Study completion date: Jun 13, 2026 to Nov 30, 2027
    • Secondary endpoints: 24 to 25
    • Site details revised at 6 of 99 sites
    v34
  19. Site details revised at 4 of 99 sitesv33
  20. Study sites: 97 to 99v32
  21. Study sites: 96 to 97v31
  22. Site details revised at 3 of 96 sitesv30
  23. Enrollment target: 200 to 300
    • Eligibility criteria revised
    • Study sites: 94 to 96
    • Secondary endpoints: 21 to 24
    v29
  24. Study sites: 91 to 94
    • Secondary endpoints: 18 to 21
    v28
  25. Site details revised at 4 of 91 sitesv27
  26. Study sites: 88 to 91v26
  27. Site details revised at 6 of 88 sitesv25
  28. Study sites: 89 to 88v24
  29. Study sites: 84 to 89v23
  30. Study sites: 82 to 84v22
  31. Study sites: 78 to 82v21
  32. Study sites: 76 to 78v20
  33. Study sites: 75 to 76v19
  34. Study sites: 73 to 75v18
  35. Study sites: 70 to 73v17
  36. Study sites: 67 to 70v16
  37. Study sites: 61 to 67v15
  38. Study sites: 55 to 61v14
  39. Eligibility criteria expanded, about 4 words
    • Study sites: 54 to 55
    • Secondary endpoints revised (18)
    v13
  40. Study sites: 46 to 54v12
  41. Study sites: 40 to 46
    • Study completion date: Nov 13, 2027 to Jun 13, 2026
    v11
  42. Study sites: 37 to 40v10
  43. Study sites: 26 to 37v9
  44. Study sites: 21 to 26
    • Start date: Oct 12, 2021 to Oct 26, 2021
    v8
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants Who Achieved SLE Responder Index (SRI4) at Week 52
Timeframe: At Week 52

Secondary (25)

Percentage of Participants Who Achieved British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) at Week 52
Percentage of Participants Who Achieved Sustained Oral Corticosteroid Control (OCS) (<=7.5 mg/Day) From Week 40 Through Week 52
Percentage of Participants Who Achieved Sustained SRI(4) Response From Week 40 Through Week 52
Percentage of Participants With SRI(6) Response at Week 52
Time to BILAG Flare Over 52 Weeks
Show 20 moreShow less
Percentage of Participants Who Achieved SRI(4) at Week 24
Percentage of Participants Who Achieved Clinical SRI(4) at Week 52
Percentage of Participants Who Achieved SRI(4) at Week 52 on Low-dose of Corticosteroids
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 52
Percentage of Participants Who Achieved Definition of Remission in SLE (DORIS) at Week 52
Change in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale From Baseline to Weeks 24 and 52
Change in 36-Item Short Form Survey, Version 2 (SF-36 V2) Bodily Pain Domain Scale From Baseline to Weeks 24 and 52
Change in SF-36 V2 Physical Component Summary Scale From Baseline to Weeks 24 and 52
Change in Active Joint Count From Baseline to Weeks 24 and 52
Percentage of Participants Who Achieved a >=50% Reduction in Active Joint Counts at Each Study Visit, Among Participants With >=4 Active Joints at Baseline
Percentage of Participants Who Achieved a >=50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at Each Study Visit
Percentage of Participants Who Achieved Sustained OCS (<=5 mg/Day) From Week 40 Through Week 52
Cumulative Corticosteroid Use Through Week 52
Annualized Flare Rate Through Week 52
Number of Participants With Adverse Events (AEs)
Number of Participants With Adverse Events of Special Interests (AESIs), Including Infusion-related Reactions (IRRs), Neutropenia, Infections, and Thrombocytopenia
Maximum Serum Concentration (Cmax) of Obinutuzumab
Trough Concentration (Ctrough) of Obinutuzumab
Area Under the Concentration-time Curve (AUC) of Obinutuzumab
Number of Participants With Anti-drug Antibodies (ADAs) to Obinutuzumab

Arms and interventions

ObinutuzumabExperimental

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.

PlaceboPlacebo comparator

Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.

Drugs: Obinutuzumab, Placebo, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride, Methylprednisolone

Sites

63 sites in 14 countries

United States 14, Brazil 7, Poland 7, Italy 5, Peru 5, United Kingdom 5, Mexico 4, South Africa 4, Argentina 3, Russia 3, New Zealand 2, Spain 2, Czechia 1, France 1