Clinical trial NCT06331312: Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Official title: A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Polymyalgia Rheumatica
Keywords: Polymyalgia Rheumatica (PMR)
secukinumab
monoclonal antibody
subcutaneous (s.c.)
extension
long-term
safety
REPLENISH
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

Detailed description: The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab).

Treatment period:

There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i.e., those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so).

Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.

Eligibility criteria: Inclusion Criteria:

* Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the "core study" - Study CAIN457C22301), AND

  * who have experienced a relapse during the treatment-free follow-up period of the core study, AND
  * who have not been on rescue treatment.
* The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.

Exclusion Criteria:

* Use of prohibited medications, as specified in the protocol
* History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
* Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
* Subjects whose participation in the extension study could expose them to an undue safety risk

Primary outcomes:
measure: Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
timeFrame: After the first dose of study treatment and within 84 days after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Arizona Arthritis and Rheumatology Associates PLLC
state: Arizona
city: Peoria
country: United States
facility: Sun Valley Arthritis Center Ltd
state: Arizona
city: Santa Monica
country: United States
facility: Orrin Troum MD and Medical Associates
state: California
city: West Hills
country: United States
facility: Center for Rheumatology Research
state: California
city: Westlake Village
country: United States
facility: Millennium Clinical Trials
state: California
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Res Ctr
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates Inc
state: Florida
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Hagerstown
country: United States
facility: Klein and Associates
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Clinical Research Inst of MI
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Research Inc
state: Texas
city: Spring
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Southport
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Heidelberg Heights
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parramatta
country: Australia
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
state: RM
city: Vina Del Mar
country: Chile
facility: Novartis Investigative Site
state: Valparaiso
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Hlucin
country: Czechia
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Zlin
country: Czechia
facility: Novartis Investigative Site
city: Gandrup
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Brest
country: France
facility: Novartis Investigative Site
city: Cholet
country: France
facility: Novartis Investigative Site
city: Colmar Cedex
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Montpellier 5
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Kawachinagano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ome
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shimonoseki
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Chuo
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Bytom
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: