Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Current status:
Approved
|
Date registered:
13/08/2024
Trial version(s)
Current: 14/06/2024
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2024065610
Protocol number
CAIN457C22301E1
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma AG
Primary sponsor: Country of origin
Novartis Pharma AG
Public title
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Acronym
Scientific title
A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Acronym
Brief summary of the study: English
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
Brief summary of the study: Arabic
دراسة تمدید متعددة المراكز ومفتوحة التسمیة حول دواء سیكوكینوماب المعطى تحت الجلد لتقییم سلامتھ وتحمّ لھ على المدى الطویل في علاج ألم العضلات الروماتیزمي
Health conditions/problem studied: Specify
Polymyalgia Rheumatica
Interventions: Specify
Biological: Secukinumab 2 x 150mg/1mL PFS secukinumab
Key inclusion and exclusion criteria: Inclusion 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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
50
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Switzerland, UK, France, Italy, Portugal, Belgium, Spain, Canada, United States, Australia,,Jordan, KSA, Oman, Kuwait, UAE, Qatar, Bahrain
Name of IMP
Secukinumab
Year of authorization
2016
Month of authorization
3
Type of IMP
Immunological
Pharmaceutical class
Interleukin 17A inhibitor (IL-17i)
Therapeutic indication
Polymyalgia Rheumatica (PMR)
Therapeutic benefit
Treatment
Biospecimen retention
Samples with DNA**
Biospecimen description
shipped to Q2 central lab
Target sample size
8
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
17/12/2024
Date of study closure: Type
Anticipated
Date of study closure: Date
25/01/2028
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement 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
Additional data URL
https://www.clinicaltrials.gov/study/NCT06331312?term=CAIN457C22301E1&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT06331312
Sources of Monetary or Material Support
Name
Novartis Pharma AG
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Nelly
Ziade
Hotel Dieu de France Hospital, Asrafieh, Lebanon
Lebanon
0096170973214
nelly.zoghbi@usj.edu.lb
Hotel Dieu de France Hospiital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
009611512002 Ext. 271 E
hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France Hospital
Nelly Ziade
Rheumatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
26/03/2024
Sami Richa
cue@usj.edu.lb
00961421229
Countries of Recruitment
Name
Australia
Japan
Switzerland
United States of America
Czech Republic
Denmark
Germany
Italy
Netherlands
Spain
Health Conditions or Problems Studied
Condition
Code
Keyword
Polymyalgia rheumatica
Polymyalgia rheumatica (M35.3)
Polymyalgia rheumatica
Interventions
Intervention
Description
Keyword
Consenting, IMP administration, Laboratory testing, imaging
Consenting, IMP administration, Laboratory testing, imaging
Consenting, IMP administration, Laboratory testing, imaging
Primary Outcomes
Name
Time points
Measure
Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame: After the first dose of study treatment and within 84 days after the last dose
The number and percentage of participants with treatment emergent AEs/SAEs will be summarized. No hypothesis testing will be performed.
Key Secondary Outcomes
Name
Time points
Measure
not provided
not provided
not provided
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Initial Submission - HDF
26/06/2024
Download as PDF
Save a PDF copy of the summary of the trial