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AP1189 in Adult Rheumatoid Arthritis (RESOLVE)
NCT05604885Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2022
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- SynAct Pharma AB
- Modality
- Small Molecules
- Drugs
- resomelagon
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial of resomelagon in rheumatoid arthritis (RA) (6 arms), sponsored by SynAct Pharma AB. Primary endpoints: Change in American College of Rheumatology 20% Response at 12 weeks and Number of reported Adverse Events at 12 weeks. Started Nov 2022; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
AP1189 60 mg
AP1189 60 mg QD + MTX (4 weeks)
AP1189 80 mg
AP1189 80 mg QD + MTX (4 weeks)
AP1189 100 mg
AP1189 100 mg QD + MTX (4 weeks)
Placebo (Part A)
Placebo QD + MTX (4 weeks)
AP1189 (Part B)
Selected Doses of AP1189 QD + MTX (12 weeks)
Placebo (Part B)
Placebo QD + MTX (12 weeks)
03
Who it enrols
Adult RA patients (ACR class I-III) with inadequate response to stable MTX, defined by >=6 swollen/tender joints and positive serology or elevated CRP.
04
Endpoints
Primary
Change in American College of Rheumatology 20% Response
Number of reported Adverse Events
Secondary
Change in American College of Rheumatology 50% Response
Change in American College of Rheumatology 70% Response
Change in Clinical Disease Activity Index
Change in Disease Activity Score 28
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