Clinical trial NCT06698796: A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dermatomyositis
Polymyositis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Participants that completed a qualifying study through Week 52.

Exclusion Criteria:

* 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.
* 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).
* Current use of any prohibited concomitant medication(s).
* Active bacterial, viral, fungal, mycobacterial or other infections.
* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.
* 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.

Primary outcomes:
measure: Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation
timeFrame: 52 weeks
measure: Number of participants with clinically significant laboratory abnormalities
timeFrame: 52 weeks
measure: Number of participants with clinically significant abnormalities in vital signs
timeFrame: 52 weeks
measure: Number of participants with clinically significant electrocardiogram (ECG) abnormalities
timeFrame: 52 weeks
measure: Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
timeFrame: 52 weeks
measure: Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 52 weeks
Secondary outcomes:
measure: Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
timeFrame: 52 weeks
measure: Change from baseline in Physician Global Activity (PhGA)
timeFrame: 52 weeks
measure: Change from baseline in extramuscular activity or disease activity score and muscle enzyme results
timeFrame: 52 weeks
measure: Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score
timeFrame: 52 weeks
measure: Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants
timeFrame: 52 weeks
measure: Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants
timeFrame: 52 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)
timeFrame: 52 weeks
measure: Change from baseline in Patient Global Activity (PtGA)
timeFrame: 52 weeks
measure: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: 52 weeks
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: 52 weeks
measure: Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS)
timeFrame: 52 Weeks
measure: Change from baseline in Healthcare Resource Utilization Questionnaire (HRU)
timeFrame: 52 weeks
measure: Change from baseline in 5-D Itch Scale Score in DM participants
timeFrame: 52 weeks
measure: Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose
timeFrame: 52 weeks
measure: Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering
timeFrame: 52 weeks
measure: Rescue therapy use assessment
timeFrame: 52 weeks
measure: Auto antibodies and immunogenicity presence
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Plovdiv
country: Bulgaria
facility: Medical Center Artmed
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: