A Phase 2 interventional study of ABBV-154 and Placebo in Polymyalgia Rheumatica, sponsored by AbbVie. Terminated at 117 sites in 15 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's enrollment of 181 is above the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ABBV-154 · Drug: Glucocorticoid
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.
Drug: ABBV-154 · Drug: Glucocorticoid
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.
Drug: ABBV-154 · Drug: Glucocorticoid
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Drug: Placebo · Drug: Glucocorticoid
Subcutaneous Injection
Subcutaneous Injection
Oral Tablet
Time to Flare
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
Time frame: From first dose of study drug to Week 52
Percentage of Participants Achieving Flare-Free State
Percentage of participants achieving flare-free state.
Time frame: Up to Week 24
Cumulative Glucocorticoid Dose
Cumulative glucocorticoid dose.
Time frame: Week 24
Change From Baseline in Glucocorticoid Dose
Change from Baseline in glucocorticoid dose.
Time frame: Week 24
| Milestone | Placebo | ABBV-154, 40mg SC | ABBV-154, 150mg SC | ABBV-154, 340mg SC |
|---|---|---|---|---|
| Started | 50 | 42 | 45 | 44 |
| Completed | 12 | 8 | 8 | 7 |
| Not completed | 38 | 34 | 37 | 37 |
| Withdrew: Adverse event | 3 | 1 | 1 | 7 |
| Withdrew: Lack of efficacy | 2 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 4 | 3 | 2 |
| Withdrew: Study terminated by sponsor | 25 | 28 | 32 | 27 |
| Withdrew: Other | 1 | 0 | 1 | 1 |
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
| days | Placebo | ABBV-154, 40mg SC | ABBV-154, 150mg SC | ABBV-154, 340mg SC |
|---|---|---|---|---|
| Time to Flare | 113 (84 to 141) | 225 (140 to NA) | NA (141 to NA) | NA (NA to NA) |
Percentage of participants achieving flare-free state.
| percentage of participants | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC |
|---|---|---|---|---|
| Percentage of Participants Achieving Flare-Free State | 11 | 13 | 15 | 24 |
Cumulative glucocorticoid dose.
| Glucocorticoid dose (mg) | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC |
|---|---|---|---|---|
| Cumulative Glucocorticoid Dose | 984.576 ± 524.6579 | 823.411 ± 397.9403 | 734.310 ± 332.3137 | 759.450 ± 381.1683 |
Change from Baseline in glucocorticoid dose.
| mg | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC |
|---|---|---|---|---|
| Change From Baseline in Glucocorticoid Dose | -4.96 ± 3.943 | -6.29 ± 3.384 | -7.40 ± 3.554 | -7.88 ± 3.398 |
Collected over All-cause mortality were reported from enrollment to the end of study, median time on follow up was 288.5, 292.0, 300.0, and 299.0 Days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug within 70 days after the last dose of study drug; mean duration on study drug was 235.2, 239.9, 234.6 and 230.3 days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/50 (0%) | 8/50 (16%) | 27/50 (54%) |
| ABBV-154 40mg SC | 0/42 (0%) | 5/42 (11.9%) | 25/42 (59.5%) |
| ABBV-154 150mg SC | 0/45 (0%) | 8/45 (17.8%) | 30/45 (66.7%) |
| ABBV-154 340mg SC | 0/44 (0%) | 9/44 (20.5%) | 37/44 (84.1%) |
| Event | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC |
|---|---|---|---|---|
| PNEUMONIAInfections and infestations | 0/50 | 0/42 | 0/45 | 4/44 |
| CORONARY ARTERY DISEASECardiac disorders | 0/50 | 1/42 | 1/45 | 0/44 |
| LEFT VENTRICULAR FAILURECardiac disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| PANCREATIC PSEUDOCYSTGastrointestinal disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| PANCREATITISGastrointestinal disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| APPENDICITIS PERFORATEDInfections and infestations | 0/50 | 1/42 | 0/45 | 0/44 |
| PERITONITISInfections and infestations | 0/50 | 1/42 | 0/45 | 0/44 |
| DEHYDRATIONMetabolism and nutrition disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| DIZZINESSNervous system disorders | 0/50 | 1/42 | 0/45 | 0/44 |
| Event | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC |
|---|---|---|---|---|
| COVID-19Infections and infestations | 9/50 | 9/42 | 5/45 | 7/44 |
| NASOPHARYNGITISInfections and infestations | 3/50 | 4/42 | 4/45 | 7/44 |
| URINARY TRACT INFECTIONInfections and infestations | 5/50 | 3/42 | 2/45 | 6/44 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 3/50 | 4/42 | 6/45 | 3/44 |
| HEADACHENervous system disorders | 2/50 | 3/42 | 4/45 | 5/44 |
| HYPERTENSIONVascular disorders | 5/50 | 1/42 | 4/45 | 3/44 |
| COUGHRespiratory, thoracic and mediastinal disorders | 0/50 | 1/42 | 1/45 | 4/44 |
| FATIGUEGeneral disorders | 2/50 | 3/42 | 4/45 | 2/44 |
| DIARRHOEAGastrointestinal disorders | 4/50 | 2/42 | 2/45 | 3/44 |
| NAUSEAGastrointestinal disorders | 2/50 | 3/42 | 2/45 | 3/44 |
| Age, Continuous(years) | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC | Total |
|---|---|---|---|---|---|
| Mean | 71.0 ± 7.15 | 67.5 ± 7.98 | 69.8 ± 8.34 | 69.1 ± 6.23 | 69.4 ± 7.50 |
| Sex: Female, Male(Participants) | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC | Total |
|---|---|---|---|---|---|
| Female | 33 | 30 | 25 | 29 | 117 |
| Male | 17 | 12 | 20 | 15 | 64 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 2 | 5 |
| Not Hispanic or Latino | 49 | 42 | 43 | 42 | 176 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Baseline Glucocorticoid Dose (mg/day)(mg/day) | Placebo | ABBV-154 40mg SC | ABBV-154 150mg SC | ABBV-154 340mg SC | Total |
|---|---|---|---|---|---|
| Least squares mean | 9.21 ± 3.801 | 9.45 ± 3.378 | 9.10 ± 3.519 | 9.52 ± 3.317 | 9.31 ± 3.495 |
Showing the first 100 of 117 sites across 15 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab fosimdesonide