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

NCT06698796 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C02510102024-514648-10-00
• Study Type: interventional
• Target: 211
• Locations: 12 countries
• Sites: 22

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.

Conditions

Dermatomyositis; Polymyositis

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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").

  52 weeks

Secondary Outcomes (17)

• Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)

  52 weeks

• Change from baseline in Physician Global Activity (PhGA)

  52 weeks

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

  52 weeks

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

  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

  52 weeks

Study Arms (1)

Dazukibart

EXPERIMENTAL

Participants will receive dazukibart via intravenous infusion every 4 weeks.

Drug: Dazukibart

Interventions

Dazukibart DRUG

anti-interferon beta therapy

Dazukibart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants that completed a qualifying study through Week 52.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, 85306, United States

RECRUITING

Arthritis & Rheumatology Research Institute, PLLC

Allen, Texas, 75013, United States

NOT YET RECRUITING

Nerve & Muscle Center of Texas

Houston, Texas, 77030, United States

NOT YET RECRUITING

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, 25801, United States

RECRUITING

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

RECRUITING

Medical Center Artmed

Plovdiv, 4000, Bulgaria

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, 230071, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

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

Ernākulam, Kerala, 682040, India

RECRUITING

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

RECRUITING

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8519, Japan

RECRUITING

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Mexico City, 06100, Mexico

RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, Masovian Voivodeship, 02-637, Poland

NOT YET RECRUITING

Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, Podlaskie Voivodeship, 15-707, Poland

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

NOT YET RECRUITING

Hacettepe Universite Hastaneleri

Altindağ, Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatomyositis; Polymyositis

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 21, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): November 25, 2027
• Study Completion (Estimated): November 25, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4); TW (1); AR (1); HU (1); IN (1); IL (1); JP (2); ME (1); CN (6); PL (2); BU (1); TU (1)