DermatomyositisPhase 2NCT05192200
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
A Phase 2 study testing Anti-Beta Interferon (PF-06823859) in people with Dermatomyositis, run by Pfizer at 25 sites in 4 countries.
Trial summary
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Anti-Beta Interferon (PF-06823859)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 20 Dec 2021to 20 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (DM), that have completed the treatment period of a qualifying study.
- Capable of giving signed informed consent.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Who cannot join
- Other 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 or, in the investigator's judgment, make the participant inappropriate for the study
- Participants who met discontinuation criteria at any point during the participating qualifying studies.
- Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has not resolved.
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States21 sites
Attune Health Research Inc.
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35294
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital - CTH
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, 66205
Mayo Clinic in Florida
Jacksonville, Florida, 32224
KU Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas, 66160
University of Kansas Medical Center
Kansas City, Kansas, 66160
NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, 10016
NYU Langone Health Clinical Research Center
New York, New York, 10016
NYU Langone Radiology - Ambulatory Care Center East 41st Street
New York, New York, 10017
Mount Sinai Doctors Dermatology
New York, New York, 10028
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Center for Human Phenomic Science
Philadelphia, Pennsylvania, 19104
University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Scottsdale, Arizona, 85259
Center for Outpatient Health
St Louis, Missouri, 63108
Washington University School of Medicine
St Louis, Missouri, 63108
Washington University School of Medicine
St Louis, Missouri, 63110
Poland2 sites
Nova Reuma Społka Partnerska
Bialystok, Podlaskie Voivodeship, 15-707
Centrum Medyczne Plejady
Krakow, 30-363
About this study
Official title: AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS ≥18 AND ≤80 WITH ACTIVE DERMATOMYOSITIS.
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
- Conditions
- Dermatomyositis
- Being tested
- Anti-Beta Interferon (PF-06823859)
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Beta Interferon (PF-06823859)Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Anti-Beta Interferon drug (PF-06823859) | Experimental | IV infusion Receives: Drug: Anti-Beta Interferon (PF-06823859) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs.
Measured: From Day 1 of dosing maximum up to Week 68
Number of Participants With Laboratory Abnormalities
Hematology laboratory parameters: hemoglobin (grams per deciliter [g/dL]); hematocrit (percentage [%]); lymphocytes (10^3 per (/) millimeter[mm]^3); lymphocytes/leukocytes (%); neutrophils (10^3/mm^3) less than (<)0.8*lower limit of normal (LLN), leukocytes (10^3/mm^3) <0.6*LLN, neutrophils (10^3/mm^3); basophils (10^3/mm^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds [sec]); prothrombin time (sec) more than (>)1.2*upper limit of normal (ULN). Clinical chemistry: potassium (milliequivalents per liter [mEq/L]); bicarbonate (mEq/L) <0.9*LLN, creatine kinase (units per liter [U/L]) >2.0*ULN, glucose (milligram per deciliter [mg/dl]); glucose-fasting (mg/dl) >1.5*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (more than or equal to [>=] 1, urine erythrocytes (scalar); urine leukocytes (scalar) >=20.
Measured: From Day 1 of dosing maximum up to Week 68
Number of Participants According to Categorization of Changes in Vital Signs
Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury [mmHg]) change >=20 mmHg increase; sitting systolic blood pressure (mmHg) change >=30 mmHg increase, sitting diastolic blood pressure (mmHg) change >=20 mmHg decrease and sitting systolic blood pressure (mmHg) change >=30 mmHg decrease.
Measured: From Day 1 of dosing maximum up to Week 68
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
ECG parameters evaluated were: PR interval value >=300 milliseconds (msec); QRS duration value >=200 msec; QT interval value >=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 less than or equal to (<=) value <480 msec, 480 <=value<500 msec and value>=500 msec.
Measured: From Day 1 of dosing maximum up to Week 68
Secondary outcomes (12)
Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Measured: Baseline (before dose 1), Week 52
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Measured: Baseline (before dose 1), Weeks 12, 24, 36 and 48
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Measured: Weeks 12, 24, 36, 48 and 52
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage.
Measured: Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage.
Measured: Weeks 12, 24, 36, 48 and 52
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
There are 6 core set measure that comprised of TIS: 1) Physician Global Assessment Score [PhGA] (from Myositis Disease Activity Assessment Tool [MDAAT], 0-100 mm or 0-10 centimeter (cm) on visual analogue scale [VAS], higher scores= worse health status); 2) Patient Global Assessment Score [PtGA] (0-100 mm or 0-10 cm on VAS, higher scores= worse status); 3) Manual Muscle Testing-8 (MMT-8) designated muscle groups (0-80, lower scores= higher level of disability); 4) Health Assessment Questionnaire Disability Index [HAQ-DI] (0-3, higher scores= worse status); 5) Global Extramuscular Disease Activity (from MDAAT, 0-10 cm on a VAS, higher scores= higher level of disability); 6) Participant's most elevated muscle enzymes. TIS was sum of all 6 improvement scores associated with the change in each core set measure. TIS ranged from 0 to 100; where TIS>=20 shows minimal improvement, TIS >=40 shows moderate improvement and TIS >= 60 shows major improvement.
Measured: Weeks 12, 24, 36, 48 and 52
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
PhGA: Investigator was asked to evaluate the participant's overall disease activity on a VAS of 0 cm (very good) to 10 cm (very poor), higher scores indicated worse health status.
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
MMT-8 is a tool that assesses muscle strength using manual muscle testing. Eight designated muscles are tested unilaterally with a total potential summed score of 0-80. Lower scores indicated a higher level of disability.
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
HAQ-DI consisted of eight sections (including dressing \& grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Creatine kinase is a muscle enzyme measured in units per liter (U/L).
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
MDAAT tool measures the degree of disease activity of extramuscular organ systems and muscle on a VAS of 0 to 10 cm, higher scores indicated higher level of disability.
Measured: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start20 Dec 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT05192200
- Sponsor's protocol ID
- C0251008
- Other IDs
- 2021-004787-10
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2021
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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.
Publications
Vleugels RA, Peeva E, Aggarwal R, Chu M, Sloan A, Rath N, Mangialardi E, Fiorentino D. Long-Term Safety and Efficacy of Dazukibart in Dermatomyositis: Combined Phase II Results From Double-Blind and Open-Label Extension Studies. J Rheumatol. 2026 Aug 15:jrheum.2026-0146. doi: 10.3899/jrheum.2026-0146. Online ahead of print.
PubMed 42542380
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS ≥18 AND ≤80 WITH ACTIVE DERMATOMYOSITIS.
- ClinicalTrials.gov ID
- NCT05192200
- Acronym / sponsor ID
- C0251008
- Conditions
- Dermatomyositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Posted 6 Feb 2025
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 research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.
| Arm | Type | Receives |
|---|---|---|
| Anti-Beta Interferon drug (PF-06823859) | Experimental | Drug: Anti-Beta Interferon (PF-06823859)IV infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (DM), that have completed the treatment period of a qualifying study.
- Capable of giving signed informed consent.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (3 listed)
- Other 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 or, in the investigator's judgment, make the participant inappropriate for the study
- Participants who met discontinuation criteria at any point during the participating qualifying studies.
- Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has 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 |
|---|---|---|
| Anti-Beta Interferon (PF-06823859)IV infusion | Drug | Anti-Beta Interferon drug (PF-06823859) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 1 of dosing maximum up to Week 68
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs.
Number of Participants With Laboratory Abnormalities
Time frame: From Day 1 of dosing maximum up to Week 68
Hematology laboratory parameters: hemoglobin (grams per deciliter [g/dL]); hematocrit (percentage [%]); lymphocytes (10^3 per (/) millimeter[mm]^3); lymphocytes/leukocytes (%); neutrophils (10^3/mm^3) less than (<)0.8*lower limit of normal (LLN), leukocytes (10^3/mm^3) <0.6*LLN, neutrophils (10^3/mm^3); basophils (10^3/mm^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds [sec]); prothrombin time (sec) more than (>)1.2*upper limit of normal (ULN). Clinical chemistry: potassium (milliequivalents per liter [mEq/L]); bicarbonate (mEq/L) <0.9*LLN, creatine kinase (units per liter [U/L]) >2.0*ULN, glucose (milligram per deciliter [mg/dl]); glucose-fasting (mg/dl) >1.5*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (more than or equal to [>=] 1, urine erythrocytes (scalar); urine leukocytes (scalar) >=20.
Number of Participants According to Categorization of Changes in Vital Signs
Time frame: From Day 1 of dosing maximum up to Week 68
Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury [mmHg]) change >=20 mmHg increase; sitting systolic blood pressure (mmHg) change >=30 mmHg increase, sitting diastolic blood pressure (mmHg) change >=20 mmHg decrease and sitting systolic blood pressure (mmHg) change >=30 mmHg decrease.
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
Time frame: From Day 1 of dosing maximum up to Week 68
ECG parameters evaluated were: PR interval value >=300 milliseconds (msec); QRS duration value >=200 msec; QT interval value >=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 less than or equal to (<=) value <480 msec, 480 <=value<500 msec and value>=500 msec.
12 secondary outcomes
Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
Time frame: Baseline (before dose 1), Week 52
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Time frame: Baseline (before dose 1), Weeks 12, 24, 36 and 48
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Time frame: Weeks 12, 24, 36, 48 and 52
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Time frame: Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Time frame: Weeks 12, 24, 36, 48 and 52
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Weeks 12, 24, 36, 48 and 52
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Time frame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42542380Vleugels RA, Peeva E, Aggarwal R, Chu M, Sloan A, Rath N, Mangialardi E, Fiorentino D. Long-Term Safety and Efficacy of Dazukibart in Dermatomyositis: Combined Phase II Results From Double-Blind and Open-Label Extension Studies. J Rheumatol. 2026 Aug 15:jrheum.2026-0146. doi: 10.3899/jrheum.2026-0146. Online ahead of print.
- 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Beta Interferon (PF-06823859) in people with Dermatomyositis, run by Pfizer at 25 sites in 4 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Poland, Hungary, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From Day 1 of dosing maximum up to Week 68). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192200, which also lists 1 linked publication.
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 6 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.