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ABBV-154 for Polymyalgia Rheumatica (AIM-PMR Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights

Summary

This trial tests ABBV-154, a new drug for treating polymyalgia rheumatica (PMR), in adults over 50 who depend on steroids. The drug aims to reduce inflammation and improve symptoms. Participants will receive regular injections and be monitored for safety and effectiveness.

Eligible Conditions
  • Polymyalgia Rheumatica

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Flare
Secondary study objectives
Change from Baseline in Glucocorticoid Dose
Cumulative Glucocorticoid Dose
Percentage of Participants Achieving Flare-Free State

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABBV-154 Dose CExperimental Treatment2 Interventions
Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group II: ABBV-154 Dose BExperimental Treatment2 Interventions
Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group III: ABBV-154 Dose AExperimental Treatment2 Interventions
Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group IV: PlaceboPlacebo Group2 Interventions
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucocorticoid
2019
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,010 Previous Clinical Trials
518,565 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica
ABBVIE INC.Study DirectorAbbVie
435 Previous Clinical Trials
159,845 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica
~44 spots leftby Oct 2025