Skip to content
DataLookout
Start free
Menu

SPIREANCT05379634

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

StatusCompleted
PhasePhase 2
Primary completion
Track this trial

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

Record History

The 50 most recent of 56 versions: 36 with changes below, 14 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Sep 16, 2026 to Sep 17, 2026
    • Site details revised at 2 of 57 sites
  2. Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (28)
    • Site details revised at 3 of 57 sites
  3. Study sites revised (57)v54
  4. Site details revised at 1 of 57 sitesv49
  5. Primary completion date changed from estimate of Sep 3, 2025 to Sep 4, 2025v46
Show 31 earlier versionsHide 31 earlier versions
  1. Primary completion date: Oct 15, 2025 to Sep 3, 2025v42
  2. Primary completion date: Oct 27, 2025 to Oct 15, 2025v41
  3. Study completion date: Sep 14, 2026 to Sep 16, 2026v39
  4. Study sites revised (57)v38
  5. Site details revised at 1 of 57 sitesv37
  6. Site details revised at 1 of 57 sitesv35
  7. Enrollment target: 35 to 36v32
  8. Enrollment target: 32 to 35
    • Primary completion date: Mar 2, 2026 to Oct 27, 2025
    • Study completion date: Oct 28, 2027 to Sep 14, 2026
    v31
  9. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 32
    • Study description shortened, about 277 words
    • Study sites revised (57)
    v30
  10. Study sites revised (57)v29
  11. Study sites revised (57)v28
  12. Site details revised at 3 of 57 sitesv27
  13. Study sites: 56 to 57v26
  14. Study sites revised (56)v25
  15. Study sites: 54 to 56
    • Study completion date: Apr 22, 2027 to Oct 28, 2027
    v24
  16. Study sites revised (54)v23
  17. Study sites: 52 to 54
    • Eligibility criteria expanded, about 3 words
    v22
  18. Study sites: 51 to 52v21
  19. Study sites: 45 to 51v20
  20. Study sites: 43 to 45v19
  21. Study sites: 42 to 43v18
  22. Study sites: 40 to 42v17
  23. Study sites: 36 to 40v16
  24. Study sites: 33 to 36v14
  25. Study sites: 27 to 33v13
  26. Study sites: 54 to 27v12
  27. Study sites: 51 to 54
    • Secondary endpoints revised (28)
    v11
  28. Study sites revised (51)v10
  29. Site details revised at 3 of 51 sitesv9
  30. Study sites: 50 to 51v8
  31. Eligibility criteria expanded, about 1 wordv7
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Timeframe: At Week 52

Secondary (26)

Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS
IMACS TIS
Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS
Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52
Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS
Show 21 moreShow less
Change From Baseline in MMT-8 at Week 24
Change From Baseline in Physician Global Assessment (PhGA) at Weeks 24 and Week 52
Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52
Change From Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52
Percentage of Participants who Achieve Oral Glucocorticoids (GC) Reduction to 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent), Among Participants on Oral GC Greater Than (>) 5 mg/day at Baseline
Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on Less Than or Equal to (<=) 5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Percentage of Participants on <=5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Percentage of Participants who Achieve At Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to 5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >5 mg/day at Baseline
Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on <=7.5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Percentage of Participants who Achieve Oral GC Reduction to <=7.5 mg/day of Oral Prednisone (or Equivalent) at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline
Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to <=7.5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline
IMACS TIS Over Time
Change From Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52
Change in CDASI Scale Score Over Time
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20
Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)
Serum Nipocalimab Concentration Over Time
Number of Participants With Anti-drug Antibody (ADA) Measured Using a Validated, Specific, and Sensitive Immunoassay Method
Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method

Arms and interventions

NipocalimabExperimental

Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.

PlaceboPlacebo comparator

Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.

Drugs: Nipocalimab, Glucocorticoids

Other: Placebo

Sites

57 sites in 13 countries

United States 19, Japan 9, Italy 4, Mexico 4, France 3, Germany 3, Spain 3, United Kingdom 3, Canada 2, Hungary 2, Poland 2, South Korea 2, Czechia 1