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
Public ClinicalTrials.gov record NCT04972968. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT04972968
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 181 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2021
- Primary completion
- Jul 23, 2023
- Completion
- Jul 23, 2023
- Last update posted
- Oct 14, 2024
2021 – 2023
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arthritis and Rheumatism Associates /ID# 232089 | Jonesboro | Arkansas | 72401-6251 | — |
| Providence Medical Foundation /ID# 228681 | Fullerton | California | 92835 | — |
| Care Access Research, Huntington Beach /ID# 228677 | Huntington Beach | California | 92648 | — |
| Purushotham & Akther Kotha MD, Inc /ID# 245391 | La Mesa | California | 91942 | — |
| Arthritis & Osteo Medical Ctr /ID# 228680 | La Palma | California | 90623-1728 | — |
| Hans Richard Barthel, M.D., Inc /ID# 231902 | Santa Barbara | California | 93108 | — |
| Medvin Clinical Research /ID# 228675 | Tujunga | California | 91042-2706 | — |
| Inland Rheum & Osteo Med Grp /ID# 228679 | Upland | California | 91786 | — |
| Denver Arthritis Clinic /ID# 245736 | Denver | Colorado | 80230 | — |
| Delaware Arthritis /ID# 230110 | Lewes | Delaware | 19958 | — |
| Arthritis & Rheumatic Disease Specialties /ID# 245448 | Aventura | Florida | 33180 | — |
| Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238 | Boca Raton | Florida | 33486 | — |
| International Medical Research /ID# 228765 | Daytona Beach | Florida | 32117 | — |
| Omega Research Debary, LLC /ID# 245450 | DeBary | Florida | 32713-2260 | — |
| Lakes Research, LLC /ID# 228757 | Miami | Florida | 33014 | — |
| HMD Research LLC /ID# 228767 | Orlando | Florida | 32819 | — |
| Springfield Clinic /ID# 228840 | Springfield | Illinois | 62702-3749 | — |
| Four Rivers Clinical Research /ID# 228858 | Paducah | Kentucky | 42001 | — |
| Rheumatology Consultants - Clinical Research /ID# 232137 | Tupelo | Mississippi | 38801-4949 | — |
| Dartmouth-Hitchcock Medical Center /ID# 229557 | Lebanon | New Hampshire | 03756 | — |
| Ocean Rheumatology, PA /ID# 232539 | Toms River | New Jersey | 08755 | — |
| Hospital for Special Surgery /ID# 228577 | New York | New York | 10021 | — |
| St. Lawrence Health System /ID# 229702 | Potsdam | New York | 13676 | — |
| University of Rochester Medical Center /ID# 232554 | Rochester | New York | 14642 | — |
| Paramount Medical Research Con /ID# 228839 | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Source, Inc. /ID# 231903 | Perrysburg | Ohio | 43551 | — |
| Altoona Ctr Clinical Res /ID# 232493 | Duncansville | Pennsylvania | 16635 | — |
| Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860 | Summerville | South Carolina | 29486-7887 | — |
| West Tennessee Research Institute /ID# 228854 | Jackson | Tennessee | 38305 | — |
| Rheumatology Care Center PLLC /ID# 232306 | Bellaire | Texas | 77401-2900 | — |
| DM Clinical Research - Tomball /ID# 245512 | Tomball | Texas | 77375 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04972968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2024 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04972968 live on ClinicalTrials.gov.