CompletedPhase 2

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study

United States, Hungary, Poland24 participantsStarted 2021-12-20

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants With Laboratory Abnormalities

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants According to Categorization of Changes in Vital Signs

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants According to Categorization of Electrocardiogram (ECG) Findings

Timeframe: From Day 1 of dosing maximum up to Week 68

Trial details

NCT IDNCT05192200

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-20

Results submitted2024-11-12

View on ClinicalTrials.gov More Dermatomyositis trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants With Laboratory Abnormalities

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants According to Categorization of Changes in Vital Signs

Timeframe: From Day 1 of dosing maximum up to Week 68

Number of Participants According to Categorization of Electrocardiogram (ECG) Findings

Timeframe: From Day 1 of dosing maximum up to Week 68