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A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520721-21-00
Acronym
M25-056
Enrollment
108
Registered
2025-09-12
Start date
2025-10-20
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

Detailed description

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12, Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12, Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) at Week 12, Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) at Week 12, Change from Baseline in DAS28 (CRP) at Week 12, Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) at Week 12, Percentage Of Participants Achieving CR per CDAI at Week 12

Interventions

DRUGUSP/Ph. Eur.ABBV-323
DRUGUniversal Placebo (Lutikizumab
DRUGRavagalimab)

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

Secondary

MeasureTime frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12, Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12, Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) at Week 12, Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) at Week 12, Change from Baseline in DAS28 (CRP) at Week 12, Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) at Week 12, Percentage Of Participants Achieving CR per CDAI at Week 12

Countries

Czechia, Germany, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026