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CTRI Number  CTRI/2024/01/061439 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] 
Scientific Title of Study   A Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of PF-06823859 in participants with active idiopathic inflammatory myopathies (including paticipants with active dermatomyositis or polymyositis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-502739-20-00  EudraCT 
Protocol C0251006 (Final Protocol Amendment 1, 11 May 2023)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Pai 
Designation  Director Clinical Site Operations – India Cluster 
Affiliation  Pfizer Limited 
Address  The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East) Mumbai-400051,MAHARASHTRA, India

Mumbai
MAHARASHTRA
400051
India 
Phone  02266932000  
Fax    
Email  Seema.Pai@pfizer.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema Pai 
Designation  Director Clinical Site Operations – India Cluster 
Affiliation  Pfizer Limited 
Address  The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East) Mumbai-400051,MAHARASHTRA, India


MAHARASHTRA
400051
India 
Phone  02266932000  
Fax    
Email  Seema.Pai@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Inc. 66 Hudson Boulevard East New York, NY 10001 
 
Primary Sponsor  
Name  Pfizer Inc. 
Address  66 Hudson Boulevard East New York, NY 10001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Belgium
Bulgaria
China
France
Germany
Hungary
India
Israel
Italy
Japan
Mexico
Poland
Republic of Korea
Slovakia
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shenoy Padmanabha  Dr Shenoy’s Care Private Limited Centre for Arthritis and Rheumatism Excellence ( CARE)  Department of Rheumatology, 2nd floor, Room no. 19, Near Toyota Showroom, NH 66, Nettoor, Cochin-682040
Ernakulam
KERALA 		 9446567000

drshenoy@drshenoycare.com 
Dr Anirudha Apte  Institute of Neurosciences  Department of Neurology, Near Valentino Business Hub, BRTS Canal Road, Opp Khatodara BRTS Bus Stand, Surat - 395001
Surat
GUJARAT 		 9377113143

drapte.ins@gmail.com 
Dr Parasar Ghosh  IPGME&R and SSKM Hospital  Department of clinical immunology and rheumatology, Clinical research room 5th floor, 244, AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL 		 9433988317

drparasar@gmail.com 
Dr Rajiva Gupta  Medanta-The Medicity - Medanta Institute of Education & Research (MIER)  Department of Rheumatology and clinical immunology, 5th floor Room no 16, Medanta The Medicity Sector 38 Gurugram Haryana 122001
Gurgaon
HARYANA 		 9810904592

Rajiva.gupta@medanta.org 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Sree Sudheendera Medical Mission Hospital  Submittted/Under Review 
IPGME&R Research Oversight Committee  Submittted/Under Review 
Medanta Institutional Ethics Committee (MIEC)  Submittted/Under Review 
UNITY HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M60||Myositis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug: PF-06823859 (anti-interferon beta therapy)  Participants will receive PF-06823859 via intravenous infusion every 4 weeks. 
Comparator Agent  Placebo : Placebo for PF-06823859  Participants will receive placebo via intravenous infusion every 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female adults (greater than equal to 18 years old)

2. Active dermatomyositis (DM) or polymyositis (PM) with age of onset:
a) 18 years old

3. Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.
 
 
ExclusionCriteria 
Details  1. Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
2. Existing diagnosis of inclusion body myositis (IBM)
3. Presence of immune-mediated necrotizing myositis (IMNM)
4. Myositis with end-stage organ involvement
5. Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment
6. Have cancer or a history of cancer within 5 years of screening
7. Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not l limited to:
8. history of major organ transplant
9. acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
10. preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder
11. major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery
12. history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
13. Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors
14. Other medical or laboratory abnormality that may increase the risk of study participation
15. Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine
16. Current use or incomplete appropriate washout period of any prohibited medication(s), including known exposure to anti-interferon beta (PF-06823859) or any type of anti-interferon beta therapy
17. Prior SOC medication that does not fulfill the criteria
18. Certain laboratory results from screening assessments that may interfere with study participation.
19. Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.  24 weeks outside of the United States (US) and 52 weeks in the US 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)

Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome 		 24 weeks outside of the US and 52 weeks in the US 
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)

Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score more than 14 will be assessed.
 		 Week 24 outside the US 
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis

Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA more than equal to 2 will be assessed 		 24 and 52 weeks in the US only 
Corticosteroid (CS) dose assessment

Normalized Area Under the Curve (AUC) of corticosteroid dose
 		 52 weeks 
Moderate change in Total Improvement Score

Total Improvement Score 0 to 100 with higher scores indicating a better outcome. 		 24 weeks in the US and 52 weeks outside of the US 
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)

Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome 		 24 weeks outside of the US and 52 weeks in the US 
Change from baseline in 5-D Itch Scale Score

5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score more than 14 will be assessed. 		 24 weeks outside of the US and 52 weeks in the US  
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome 		 24 weeks outside of the US and 52 weeks in the US 
Response in corticosteroid tapering

At least 50% reduction from baseline or reduction in corticosteroid (CS) dose to less than 7.5 mg/day at Week 52 for participants with baseline CS dose more than equal to 10 mg/day 		 52 weeks US only 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.

This study is seeking participants who:

  • Are 18 years of age or older.
  • Have active DM or active PM.

  • Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant.

    • Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body.

Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position.

Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it).

The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site.

The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective.

Participants will take part in this study for about 13 months. During this time, participants will have 16 study visits. These visits will be performed at the study site, but some study visits may be available at home or via mobile clinic if the study location participates in this option.

 
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