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NCT06865105

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

StatusRecruiting
PhasePhase 2
SponsorAbbVie
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 7 months later.

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Record History

All 39 versions: 37 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Aug 2029 Show 6 more changesShow less
    • Enrollment increased: 120 → 300 participants
    • Eligibility criteria expanded, about 27 words
    • Trial sites expanded: 37 → 41 locations
    • Interventions modified
    • Trial arms changed: 3 → 9
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Study sites: 36 to 37v38
  3. Site details revised at 1 of 36 sitesv37
  4. Study sites: 35 to 36v36
  5. Study sites revised (35)v35
Show 31 earlier versionsHide 31 earlier versions
  1. Study sites: 33 to 35
    • Primary completion date: Jan 2028 to Dec 2027
    v34
  2. Study sites: 32 to 33v33
  3. Study sites: 31 to 32v32
  4. Study sites: 30 to 31v31
  5. Study sites: 29 to 30v30
  6. Study sites: 28 to 29v29
  7. Study sites: 27 to 28v28
  8. Study sites: 26 to 27v27
  9. Study sites: 25 to 26v26
  10. Study sites: 24 to 25v25
  11. Study sites: 22 to 24v24
  12. Study sites: 21 to 22v23
  13. Study sites: 20 to 21v22
  14. Study sites: 19 to 20v21
  15. Study sites: 18 to 19v20
  16. Study sites: 16 to 18v19
  17. Study sites: 15 to 16v18
  18. Study sites: 13 to 15v16
  19. Study sites: 12 to 13v15
  20. Study sites: 11 to 12v14
  21. Study sites: 9 to 11v13
  22. Study sites: 8 to 9v12
  23. Study sites: 7 to 8v11
  24. Study sites: 6 to 7v10
  25. Study sites: 5 to 6v9
  26. Study sites: 4 to 5
    • Start date: Apr 15, 2025 to Apr 11, 2025
    v7
  27. Start date changed from estimate of Apr 18, 2025 to Apr 15, 2025v6
  28. Study sites: 3 to 4v5
  29. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v4
  30. Start date: Jun 30, 2025 to Apr 18, 2025v3
  31. Start date: Apr 18, 2025 to Jun 30, 2025
    • Eligibility criteria expanded, about 26 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Timeframe: At Week 16
Number of Participants With Adverse Events (AEs)
Timeframe: Up to Week 52

Secondary (4)

Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline)

Arms and interventions

Substudy 1: Risankizumab MonotherapyExperimental

Participants will receive risankizumab

Substudy 1: Lutikizumab MonotherapyExperimental

Participants will initially receive lutikizumab Dose A followed by Lutikizumab Dose B every other week.

Substudy 1: Lutikizumab and Risankizumab Combination TherapyExperimental

Participants will be administered lutikizumab and risankizumab at the same time following the same dosing regimen as the monotherapy arms.

Substudy 2: ABBV-701 MonotherapyExperimental

Participants will initially receive ABBV-701.

Substudy 2: Risankizumab MonotherapyExperimental

Participants will receive risankizumab.

Substudy 2: ABBV-701 and Risankizumab Combination TherapyExperimental

Participants will be administered ABBV-701 and risankizumab at the same time following the same dosing regimen as the monotherapy arms.

Substudy 3: ABBV-547 Dose AExperimental

Participants will receive ABBV-547 Dose A.

Substudy 3: ABBV-547 Dose BExperimental

Participants will receive ABBV-547 Dose B.

Substudy 3: ABBV-547 Dose CExperimental

Participants will receive ABBV-547 Dose C.

Drugs: Lutikizumab, Risankizumab, ABBV-701, ABBV-547

Sites

41 sites in 6 countries

United States 19, France 5, Hungary 5, Poland 5, Czechia 4, Canada 3