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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04972968




Registration number
NCT04972968
Ethics application status
Date submitted
13/07/2021
Date registered
22/07/2021

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2021-000648-23
Secondary ID [2] 0 0
M20-370
Universal Trial Number (UTN)
Trial acronym
AIM-PMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyalgia Rheumatica 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-154
Treatment: Drugs - Placebo
Treatment: Drugs - Glucocorticoid

Experimental: ABBV-154 Dose A - 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.

Experimental: ABBV-154 Dose B - 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.

Experimental: ABBV-154 Dose C - 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.

Placebo comparator: Placebo - Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.


Treatment: Drugs: ABBV-154
Subcutaneous Injection

Treatment: Drugs: Placebo
Subcutaneous Injection

Treatment: Drugs: Glucocorticoid
Oral Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Flare
Timepoint [1] 0 0
From first dose of study drug to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Flare-Free State
Timepoint [1] 0 0
Up to Week 24
Secondary outcome [2] 0 0
Cumulative Glucocorticoid Dose
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in Glucocorticoid Dose
Timepoint [3] 0 0
Week 24

Eligibility
Key inclusion criteria
* Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
* Must have had at least 2 episodes of unequivocal PMR flare.
* Must be on a stable dose of prednisone.
* Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have been treated with a prior TNF antagonist.
* Current use of immunomodulators other than prednisone and hydroxychloroquine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/07/2023
Sample size
Target
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 229166 - Botany
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital /ID# 244888 - Camperdown
Recruitment hospital [3] 0 0
BJC Health /ID# 244839 - Paramatta
Recruitment hospital [4] 0 0
Tasman Health Care /ID# 230829 - Southport
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital /ID# 229049 - Woodville South
Recruitment hospital [6] 0 0
Emeritus Research /ID# 229270 - Camberwell
Recruitment hospital [7] 0 0
Austin Health /ID# 229164 - Heidelberg
Recruitment hospital [8] 0 0
Fiona Stanley Hospital /ID# 229050 - Murdoch
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2150 - Paramatta
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Delaware
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Florida
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Illinois
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Kentucky
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Mississippi
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New Hampshire
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New Jersey
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New York
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Austria
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Wien
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Canada
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Alberta
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Ontario
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Doubs
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Finistere
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Herault
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Paris
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Baden-Wuerttemberg
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Germany
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Germany
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Germany
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Hamburg
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Germany
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Ratingen
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Hungary
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Hajdu-Bihar
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Zala
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Budapest
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Gyula
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Kistarcsa
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Szekesfehervar
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Szentes
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Torino
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Pavia
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Groningen
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Canterbury
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Waikato
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Wellington
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Christchurch Central
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Poland
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Dolnoslaskie
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Kujawsko-pomorskie
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Mazowieckie
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Podlaskie
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Wielkopolskie
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A Coruna
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Barcelona
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Cantabria
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Spain
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Santa Cruz De Tenerife
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Madrid
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United Kingdom
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Cambridgeshire
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London, City Of
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Norfolk
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Wales
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Coventry
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Edinburgh
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Liverpool
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United Kingdom
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Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04972968