A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

Phase 3RecruitingNCT06698796

Pfizer211 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States

NOT_YET_RECRUITING

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, United States

RECRUITING

Medical Center Artmed

Plovdiv, Bulgaria

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Beijing Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

Ernākulam, Kerala, India

NOT_YET_RECRUITING

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

NOT_YET_RECRUITING

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation

An AE is any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are AEs that are absent before treatment or that worsened relative to pretreatment state. Pre-defined AESI for this study are outlined in study protocol.

Time frame: 52 weeks

Number of participants with clinically significant laboratory abnormalities

Clinically significant laboratory abnormalities are those that meet the Common Terminology Criteria for Adverse Events (CTCAE) definition.

Time frame: 52 weeks

Number of participants with clinically significant abnormalities in vital signs

Clinically significant vital sign abnormalities include pulse rate \<40, \>100 or \>120 bpm; systolic blood pressure increase from baseline ≥30 or decrease ≤30 mmHg; diastolic blood pressure increase from baseline ≥20 or decrease ≤20 mmHg.

Time frame: 52 weeks

Number of participants with clinically significant electrocardiogram (ECG) abnormalities

Clinically significant ECG abnormalities include mild (\>450-480 millisecond \[msec\]), moderate (\>480-500 msec or 30-60 msec increase from baseline), and severe (\>500 msec or \>60 msec increase from baseline) QTc prolongation.

Time frame: 52 weeks

Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a measure of gas exchange diffusion capacity.

Time frame: 52 weeks

Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS assesses whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

Time frame: 52 weeks

Secondary Outcomes

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

Time frame: 52 weeks

Change from baseline in Physician Global Activity (PhGA)

Physician Global Activity 0 to 10 scale with higher scores indicating a worse outcome

Time frame: 52 weeks

Change from baseline in extramuscular activity or disease activity score and muscle enzyme results

Results come from Total Improvement Score 0 to 100 with higher scores indicating a better outcome and laboratory values

Time frame: 52 weeks

Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score

Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

Time frame: 52 weeks

Percent change from baseline and change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in DM participants

Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome

Time frame: 52 weeks

Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants

Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score 0 to 32 with higher scores indicating a worse outcome

Time frame: 52 weeks

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

Time frame: 52 weeks

A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts