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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05767034




Registration number
NCT05767034
Ethics application status
Date submitted
6/03/2023
Date registered
14/03/2023

Titles & IDs
Public title
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
Scientific title
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
Secondary ID [1] 0 0
2022-501895-25-00
Secondary ID [2] 0 0
CAIN457C22301
Universal Trial Number (UTN)
Trial acronym
REPLENISH
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 - Secukinumab 300 mg
Treatment: Drugs - Secukinumab 150 mg
Other interventions - Placebo to secukinumab

Experimental: Secukinumab 300 mg - randomized in 1:1:1 ratio every 4 weeks

Experimental: Secukinumab 150 mg - randomized in 1:1:1 ratio every 4 weeks

Placebo comparator: Placebo to secukinumab - randomized in 1:1:1 ratio every 4 weeks


Treatment: Drugs: Secukinumab 300 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Treatment: Drugs: Secukinumab 150 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Other interventions: Placebo to secukinumab
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving sustained remission
Timepoint [1] 0 0
at Week 52
Secondary outcome [1] 0 0
Proportion of patients achieving complete sustained remission
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Time to first use of escape treatment or rescue treatment as measured in days
Timepoint [3] 0 0
52 Weeks
Secondary outcome [4] 0 0
Change in FACIT-Fatigue Score
Timepoint [4] 0 0
52 Weeks
Secondary outcome [5] 0 0
Change in HAQ-DI score
Timepoint [5] 0 0
52 Weeks

Eligibility
Key inclusion criteria
* Signed informed consent must be obtained prior to participation in the study
* Male or non-pregnant, non-lactating female participants at least 50 years of age.
* Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants = 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (= 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:

* Morning stiffness > 45 minutes (min) (2 points)
* Hip pain or restricted range of motion (1 point)
* Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
* Absence of other joint involvement (1 point)
* Participants must have a history of being treated for at least 8 consecutive weeks with prednisone = 10 mg/day, or equivalent dose of another GC at any time prior to screening
* Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is = 5 mg/day (or equivalent dose of another GC) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following:

* Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of PMR relapse (such as constitutional symptoms) within 12 weeks prior to BSL that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia.
* Elevated ESR (= 30 mm/hr) and/or elevated CRP (> upper limit of normal (ULN)) attributable to PMR at the time of relapse and/or at screening
* Participants must have been treated as per local treatment recommendations following the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 25 mg/day at screening and during the screening period
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence/history of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result
* Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis
* Concurrent diagnosis or history of neuropathic muscular diseases or fibromyalgia
* Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment)
* Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
* Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within 12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who did not respond to or experienced a relapse during treatment are excluded from enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/02/2026
Actual
Sample size
Target
Accrual to date
Final
381
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg Heights
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parramatta
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Belgium
State/province [14] 0 0
Liege
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Brazil
State/province [17] 0 0
Sao Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Chile
State/province [19] 0 0
Region De Valparaiso
Country [20] 0 0
Chile
State/province [20] 0 0
RM
Country [21] 0 0
Chile
State/province [21] 0 0
Santiago
Country [22] 0 0
Colombia
State/province [22] 0 0
Atlantico
Country [23] 0 0
Colombia
State/province [23] 0 0
Valle Del Cauca
Country [24] 0 0
Colombia
State/province [24] 0 0
Barranquilla
Country [25] 0 0
Colombia
State/province [25] 0 0
Bogota
Country [26] 0 0
Czechia
State/province [26] 0 0
Czech Republic
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
Czechia
State/province [28] 0 0
Hlucin
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 4
Country [31] 0 0
Czechia
State/province [31] 0 0
Uherske Hradiste
Country [32] 0 0
Czechia
State/province [32] 0 0
Zlin
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Denmark
State/province [33] 0 0
Aarhus N
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Denmark
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Esbjerg
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Denmark
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Gandrup
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Denmark
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Vejle
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France
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Haute Vienne
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France
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Val De Marne
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France
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Aix en Provence
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France
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Brest
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France
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Cholet
Country [42] 0 0
France
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Colmar Cedex
Country [43] 0 0
France
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Dijon
Country [44] 0 0
France
State/province [44] 0 0
Le Mans
Country [45] 0 0
France
State/province [45] 0 0
Montpellier Cedex 5
Country [46] 0 0
France
State/province [46] 0 0
Nantes Cedex 1
Country [47] 0 0
France
State/province [47] 0 0
Reims
Country [48] 0 0
France
State/province [48] 0 0
Strasbourg
Country [49] 0 0
France
State/province [49] 0 0
Toulouse
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
State/province [54] 0 0
Herne
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Germany
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Ratingen
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Germany
State/province [56] 0 0
Rendsburg
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Germany
State/province [57] 0 0
Wuerzburg
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Hungary
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Budapest
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Hungary
State/province [59] 0 0
Szeged
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Hungary
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Veszprem
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Iceland
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Reykjavik
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Ireland
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Dublin
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Israel
State/province [63] 0 0
Ramat Gan
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Israel
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Tel Aviv
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Italy
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BZ
Country [66] 0 0
Italy
State/province [66] 0 0
MI
Country [67] 0 0
Italy
State/province [67] 0 0
PG
Country [68] 0 0
Italy
State/province [68] 0 0
PV
Country [69] 0 0
Italy
State/province [69] 0 0
RE
Country [70] 0 0
Japan
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Chiba
Country [71] 0 0
Japan
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Fukuoka
Country [72] 0 0
Japan
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Hokkaido
Country [73] 0 0
Japan
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Kagawa
Country [74] 0 0
Japan
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Kanagawa
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Japan
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Nagano
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Japan
State/province [76] 0 0
Oita
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
State/province [80] 0 0
Yamanashi
Country [81] 0 0
Japan
State/province [81] 0 0
Okayama
Country [82] 0 0
Lebanon
State/province [82] 0 0
Ashrafieh
Country [83] 0 0
Mexico
State/province [83] 0 0
Jalisco
Country [84] 0 0
Netherlands
State/province [84] 0 0
Almelo
Country [85] 0 0
Netherlands
State/province [85] 0 0
Groningen
Country [86] 0 0
Netherlands
State/province [86] 0 0
Rotterdam
Country [87] 0 0
Poland
State/province [87] 0 0
Bytom
Country [88] 0 0
Poland
State/province [88] 0 0
Lublin
Country [89] 0 0
Poland
State/province [89] 0 0
Warszawa
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Panorama
Country [92] 0 0
South Africa
State/province [92] 0 0
Stellenbosch
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Spain
State/province [93] 0 0
Andalucia
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Comunidad Valenciana
Country [96] 0 0
Spain
State/province [96] 0 0
Galicia
Country [97] 0 0
Spain
State/province [97] 0 0
Pais Vasco
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid
Country [99] 0 0
Sweden
State/province [99] 0 0
SE
Country [100] 0 0
Switzerland
State/province [100] 0 0
Basel
Country [101] 0 0
Switzerland
State/province [101] 0 0
Fribourg
Country [102] 0 0
Switzerland
State/province [102] 0 0
St Gallen
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Barnet
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Hull
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
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?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05767034