| CTRI Number |
CTRI/2025/04/085426 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
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An open-label extension study with dazukibart for participants with idiopathic inflammatory myopathies (including DM or PM) who have completed the treatment period of a qualifying parent study. |
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Scientific Title of Study
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A Phase 3, Multi-Center, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Dazukibart in Participants with Idiopathic Inflammatory Myopathies (Including Participants with Dermatomyositis or Polymyositis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol no C0251010 Version Original 08 Apr 2024 |
Protocol Number |
| 2022-502739-20-00 |
EudraCT |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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 |
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Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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 |
|
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Source of Monetary or Material Support
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| Pfizer Inc.
66 Hudson Boulevard East New York, NY 10001 United States |
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Primary Sponsor
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| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East New York, NY 10001 United States |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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| Name |
Address |
| MS Pfizer Limited |
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400 051
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Countries of Recruitment
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Argentina
Belgium
Bulgaria
China
France
Germany
Hungary
Israel
Italy
Japan
Mexico
Poland
Slovakia
Spain
Taiwan
Turkey
United Kingdom
United States of America
India
Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmanabha Shenoy D |
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy s Care Private Limited) |
Centre for Arthritis and Rheumatism Excellence (CARE),
Near Toyota Showroom, NH 66, Nettoor, Cochin-682040, Kerala, India
Ernakulam
KERALA |
9446567000
drdpshenoy@gmail.com |
| Dr Anirudha Apte |
Institute of Neurosciences, |
Near Valentino Business Hub, BRTS Canal Road, Opp Khatodara BRTS Bus Stand, Surat, Gujarat 395001, India
Surat
GUJARAT |
7405698000
drapte.ins@gmail.com |
| Dr Parasar Ghosh |
IPGME&R and SSKM Hospital |
Department of Rheumatology and Clinical Immunology, 244, AJC Bose Road, West Bengal– 700020, Kolkata, India
Kolkata
WEST BENGAL |
9433988317
drparasar@gmail.com |
| Dr Rajiva Gupta |
Medanta The Medicity, Gurugram |
CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001, India
Gurgaon
HARYANA |
9810904592
rajiva.gupta@medanta.org |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sree Sudheendera Medical Mission Hospital |
Approved |
| IPGME&R Research Oversight Committee |
Approved |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
| UNITY HOSPITAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M608||Other myositis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Drug: PF-06823859
(anti-interferon beta therapy) |
Participants will receive 600 mg IV every 4 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants that completed a qualifying study through Week 52 |
|
| ExclusionCriteria |
| Details |
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
2. Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local
requirement) or 5 half-lives preceding baseline in this study (whichever is longer).
3. Current use of any prohibited concomitant medication(s).
4. Active bacterial, viral, fungal, mycobacterial or other infections.
5. Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.
6. Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
1. Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation
2. Number of participants with clinically significant laboratory abnormalities
3. Number of participants with clinically significant abnormalities in vital signs
4. Number of participants with clinically significant electrocardiogram (ECG) abnormalities
5. Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
6. Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) |
52 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
1. Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
2. Change from baseline in Physician Global Activity (PhGA)
3. Change from baseline in extramuscular activity or disease activity score and muscle enzyme results
4. Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score
5. Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants |
52 weeks |
6. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants
7. Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)
8. Change from baseline in Patient Global Activity (PtGA)
9. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
10. Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |
52 weeks |
11. Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS)
12. Change from baseline in Healthcare Resource Utilization Questionnaire (HRU)
13. Change from baseline in 5-D Itch Scale Score in DM participants
14. Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose
15. Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering
16. Rescue therapy use assessment
17. Auto antibodies and immunogenicity presence
|
52 weeks |
|
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Target Sample Size
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Total Sample Size="211"
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" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="1"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]). Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM. DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash. These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work. This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up. The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months. There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up. |