Health Trials

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

ConditionsDermatomyositisPolymyositis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Participants that completed a qualifying study through Week 52.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dazukibart

    Drug

    anti-interferon beta therapy

Treatment groups

211 Participants
are divided into 1 treatment group
Group A: DazukibartExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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