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)

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.

Interventions

• Drug Dazukibart
  anti-interferon beta therapy

Primary outcome measures

• Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation [Time frame: 52 weeks]
• Number of participants with clinically significant laboratory abnormalities [Time frame: 52 weeks]
• Number of participants with clinically significant abnormalities in vital signs [Time frame: 52 weeks]
• Number of participants with clinically significant electrocardiogram (ECG) abnormalities [Time frame: 52 weeks]
• Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [Time frame: 52 weeks]
• Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: 52 weeks]

Secondary outcome measures (12)

• Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) [Time frame: 52 weeks]
• Change from baseline in Physician Global Activity (PhGA) [Time frame: 52 weeks]
• Change from baseline in extramuscular activity or disease activity score and muscle enzyme results [Time frame: 52 weeks]
• Minimal, Moderate, and Major improvement in Total Improvement Score (TIS) and TIS (continuous) score [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 [Time frame: 52 weeks]
• Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score (CDASI-D) in DM participants [Time frame: 52 weeks]
• Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) [Time frame: 52 weeks]
• Change from baseline in Patient Global Activity (PtGA) [Time frame: 52 weeks]
• Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [Time frame: 52 weeks]
• Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time frame: 52 weeks]
• Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS) [Time frame: 52 Weeks]
• Change from baseline in Healthcare Resource Utilization Questionnaire (HRU) [Time frame: 52 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 7 centers

• Anhui Provincial Hospital — Hefei
• The Second Affiliated Hospital of Nanchang University — Nanchang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• Renji Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
• Renji Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
• First Affiliated Hospital of Kunming Medical University — Kunming
• Peking Union Medical College Hospital — Beijing

United States · 4 centers

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale
• Arthritis & Rheumatology Research Institute, PLLC — Allen
• Nerve & Muscle Center of Texas — Houston
• Rheumatology & Pulmonary Clinic — Beckley

Japan · 2 centers

• Institute of Science Tokyo Hospital — Bunkyo-ku
• Nippon Medical School Hospital — Bunkyo-ku

Poland · 2 centers

• Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji — Warsaw
• Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty — Bialystok

Taiwan · 2 centers

• Chi Mei Medical Center — Tainan
• National Taiwan University Hospital — Taipei

Argentina · 1 center

• Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman

Bulgaria · 1 center

• Medical Center Artmed — Plovdiv

Hungary · 1 center

• Debreceni Egyetem Klinikai Kozpont — Debrecen

India · 1 center

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

Israel · 1 center

• Sheba Medical Center — Ramat Gan

Mexico · 1 center

• Cryptex Investigación Clínica S.A. de C.V. — Cuauhtémoc

Turkey (Türkiye) · 1 center

• Hacettepe Universite Hastaneleri — Altindağ

Identifiers

NCT: NCT06698796 · C0251010 · 2024-514648-10-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗