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Zemprocitinib in moderate-to-severe rheumatoid arthritis after bDMARD failure
NCT06276998Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2023
- Primary completion
- Aug 2025
- Countries
- 1
- Sponsor
- Lynk Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- zemprocitinib
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial in rheumatoid arthritis (RA) comparing LNK01001 12 mg with Placebo / LNK01001 12 mg (2 arms). Primary endpoint: American College of Rheumatology 20% Response at 24 weeks. Started Dec 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LNK01001 12 mg
LNK01001 12 mg BID throughout the study
Placebo / LNK01001 12 mg
Placebo BID for 24 weeks, then LNK01001 12 mg BID
03
Who it enrols
Adults aged 18+ with rheumatoid arthritis for ≥3 months, ≥6 swollen and ≥6 tender joints, elevated ESR or hsCRP, on stable csDMARDs for ≥4 weeks, with inadequate response to ≥1 bDMARD. Excludes prior JAK inhibitor exposure with inadequate response/intolerance, recent glucocorticoid injections, other systemic inflammatory diseases, recent malignancy, and uncontrolled comorbidities.
04
Endpoints
Primary
American College of Rheumatology 20% Response
Secondary
Disease Activity Score 28 (CRP)
American College of Rheumatology 50% Response
Health Assessment Questionnaire - Disability Index
American College of Rheumatology 70% Response
Low Disease Activity Based on DAS28-CRP
Clinical Remission Based on DAS28-CRP
American College of Rheumatology 20% Response
Severity of Morning Stiffness
05
Results
Primary endpoints met
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