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Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) (REPLENISH)

Primary Purpose

Polymyalgia Rheumatica

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab 300 mg
Secukinumab 150 mg
Placebo to secukinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica, secukinumab, monoclonal antibody, prednisone taper regimen, glucocorticoid, PMR

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) 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) 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 Exclusion Criteria: Evidence 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 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

Sites / Locations

  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Secukinumab 300 mg

Secukinumab 150 mg

Placebo to secukinumab

Arm Description

randomized in 1:1:1 ratio every 4 weeks

randomized in 1:1:1 ratio every 4 weeks

randomized in 1:1:1 ratio every 4 weeks

Outcomes

Primary Outcome Measures

Proportion of participants achieving sustained remission
Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: no use of escape treatment or rescue treatment prior to Week 12 no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12 no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12

Secondary Outcome Measures

Proportion of patients achieving complete sustained remission
Complete sustained remission at Week 52 is defined as participant meeting all of the following: achieved sustained remission no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at ≥2 consecutive scheduled visits from Week 12 to Week 52
Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up
Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up
Time to first use of escape treatment or rescue treatment as measured in days
First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used
Change in FACIT-Fatigue Score
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR.
Change in HAQ-DI score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR.

Full Information

First Posted
March 6, 2023
Last Updated
October 24, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05767034
Brief Title
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
Acronym
REPLENISH
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
July 7, 2025 (Anticipated)
Study Completion Date
December 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 360 PMR patients who had recently relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks, with last IMP administration at 48 weeks, active drug or placebo) in combination with prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from Baseline) will be included. Dosing will be once every week for the first 4 weeks, and once every 4 weeks thereafter via pre-filled syringe. The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo with respect to the proportion of patients in sustained remission at Week 52. Primary secondary objectives are to assess difference in proportion of patients achieving complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to first use of escape treatment or rescue treatment through Week 52. Key safety data will be collected, along with Patient Reported Outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
Polymyalgia Rheumatica, secukinumab, monoclonal antibody, prednisone taper regimen, glucocorticoid, PMR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab 300 mg
Arm Type
Experimental
Arm Description
randomized in 1:1:1 ratio every 4 weeks
Arm Title
Secukinumab 150 mg
Arm Type
Experimental
Arm Description
randomized in 1:1:1 ratio every 4 weeks
Arm Title
Placebo to secukinumab
Arm Type
Placebo Comparator
Arm Description
randomized in 1:1:1 ratio every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Secukinumab 300 mg
Other Intervention Name(s)
AIN457
Intervention Description
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Intervention Type
Drug
Intervention Name(s)
Secukinumab 150 mg
Other Intervention Name(s)
AIN457
Intervention Description
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Intervention Type
Other
Intervention Name(s)
Placebo to secukinumab
Intervention Description
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Primary Outcome Measure Information:
Title
Proportion of participants achieving sustained remission
Description
Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: no use of escape treatment or rescue treatment prior to Week 12 no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12 no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12
Time Frame
at Week 52
Secondary Outcome Measure Information:
Title
Proportion of patients achieving complete sustained remission
Description
Complete sustained remission at Week 52 is defined as participant meeting all of the following: achieved sustained remission no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at ≥2 consecutive scheduled visits from Week 12 to Week 52
Time Frame
52 Weeks
Title
Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up
Description
Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up
Time Frame
52 Weeks
Title
Time to first use of escape treatment or rescue treatment as measured in days
Description
First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used
Time Frame
52 Weeks
Title
Change in FACIT-Fatigue Score
Description
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR.
Time Frame
52 Weeks
Title
Change in HAQ-DI score
Description
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR.
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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) 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 Exclusion Criteria: Evidence 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Spring
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
State/Province
Buenos Aires
ZIP/Postal Code
C1055AAF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
State/Province
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vina del Mar
State/Province
Region De Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8380465
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vitacura
State/Province
Santiago
ZIP/Postal Code
7640881
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
7500571
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cholet
ZIP/Postal Code
49325
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris 13
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-8516
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fukuoka city
State/Province
Fukuoka
ZIP/Postal Code
814 0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Asahikawa-city
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nagano-city
State/Province
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
856-0836
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beppu
State/Province
Oita
ZIP/Postal Code
874-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bunkyo ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8524
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ome
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chuo-city
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pendik
State/Province
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

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