DermatomyositisPhase 3NCT06698796
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
A Phase 3 study testing Dazukibart in people with Dermatomyositis and Polymyositis, run by Pfizer at 26 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis, Polymyositis
- What is being tested?
- Dazukibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 26 sitesin 12 countries
- Study dates
- 22 Jan 2025to 29 Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants that completed a qualifying study through Week 52.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 12 countries
China7 sites, 7 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230071
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330036
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
United States4 sites, 3 recruiting
- Active, not recruiting
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801
- Not yet recruiting
Arthritis & Rheumatology Research Institute, PLLC
Frisco, Texas, 75035
- Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306
- Recruiting
Nerve & Muscle Center of Texas
Houston, Texas, 77030
Argentina2 sites, 2 recruiting
- Recruiting
IR Medical Center SA - Instituto de Reumatologia
Mendoza, Mendoza Province, T5500
- Recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL
India2 sites, 2 recruiting
- Recruiting
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Ernākulam, Kerala, 682040
- Recruiting
Medanta - The Medicity
Gurugram, Haryana, 122001
Japan2 sites, 2 recruiting
- Recruiting
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Poland2 sites, 2 recruiting
- Recruiting
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, 15-707
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Masovian Voivodeship, 02-637
Taiwan2 sites, 2 recruiting
- Recruiting
Chi Mei Medical Center
Tainan, 71004
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Hungary1 site, 1 recruiting
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5262100
Mexico1 site, 1 recruiting
- Recruiting
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Mexico City, 06100
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe Universite Hastaneleri
Altindağ, Ankara, 06230
About this study
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)
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.
Read more
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
- Being tested
- Dazukibart
- Medical subject headings
- Dermatomyositis, Polymyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DazukibartDrug
anti-interferon beta therapy
| Study group | Role | What they receive |
|---|---|---|
| Dazukibart | Experimental | Participants will receive dazukibart via intravenous infusion every 4 weeks. Receives: Drug: Dazukibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 52 weeks
Secondary outcomes (17)
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
Measured: 52 weeks
Change from baseline in Physician Global Activity (PhGA)
Physician Global Activity 0 to 10 scale with higher scores indicating a worse outcome
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 52 weeks
Change from baseline in Patient Global Activity (PtGA)
Patient Global Activity 10-point numeric rating scale with higher scores indicating worse outcome
Measured: 52 weeks
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Health Assessment Questionnaire-Disability Index 20 questions with 0 to 3 scale where higher scores indicate a worse outcome
Measured: 52 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome
Measured: 52 weeks
Change from baseline in EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL Visual Analog Scale (EQ-VAS)
EuroQoL 5 Dimensions and EuroQoL Visual Analog Scale with higher scores indicating a worse outcome
Measured: 52 Weeks
Change from baseline in Healthcare Resource Utilization Questionnaire (HRU)
Healthcare Resource Utilization Questionnaire measures the healthcare utilization burden while on treatment
Measured: 52 weeks
Change from baseline in 5-D Itch Scale Score in DM participants
5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome
Measured: 52 weeks
Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose
CS and non-steroid immunosuppressant/immunomodulator and antimalarial dose
Measured: 52 weeks
Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering
CS dose ≤5 mg/day or CS and non-steroid immunosuppressant/immunomodulator and antimalarial free
Measured: 52 weeks
Rescue therapy use assessment
Rescue therapy received during the study and number of cycles
Measured: 52 weeks
Auto antibodies and immunogenicity presence
Auto antibody lab assessment (eg. TIF1-γ/P155, NXP2/P140, SAE, JO-1 and MDA-5) and ADAs/Nabs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start22 Jan 2025
- Primary completion29 Jul 2031 (estimated)
- Study completion29 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698796
- Sponsor's protocol ID
- C0251010
- Other IDs
- 2024-514648-10-00
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06698796
- Acronym / sponsor ID
- C0251010
- Conditions
- Dermatomyositis, Polymyositis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 29 Jul 2031 (estimated)
- Study completion
- 29 Jul 2031 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dazukibart | Experimental | Drug: DazukibartParticipants will receive dazukibart via intravenous infusion every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants that completed a qualifying study through Week 52.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dazukibartanti-interferon beta therapy | Drug | Dazukibart |
Primary outcome
Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation
Time frame: 52 weeks
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.
Number of participants with clinically significant laboratory abnormalities
Time frame: 52 weeks
Clinically significant laboratory abnormalities are those that meet the Common Terminology Criteria for Adverse Events (CTCAE) definition.
Number of participants with clinically significant abnormalities in vital signs
Time frame: 52 weeks
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.
Number of participants with clinically significant electrocardiogram (ECG) abnormalities
Time frame: 52 weeks
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.
Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Time frame: 52 weeks
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.
Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 52 weeks
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").
17 secondary outcomes
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
Change from baseline in 5-D Itch Scale Score in DM participants
Time frame: 52 weeks
Change from baseline in corticosteroid (CS) and non-steroid immunosuppressant/immunomodulator and antimalarial dose
Time frame: 52 weeks
Response in CS and non-steroid immunosuppressant/immunomodulator and antimalarial tapering
Time frame: 52 weeks
Rescue therapy use assessment
Time frame: 52 weeks
Auto antibodies and immunogenicity presence
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
26 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dazukibart in people with Dermatomyositis and Polymyositis, run by Pfizer at 26 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China, United States, Argentina, India, Japan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation (time frame: 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.