A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154 (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 from first dose of study drug to week 52

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
Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug 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

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