Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06823859 · 3 trials · 2 indications
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were the events between first dose of study drug and up to Day 157, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious (if occurred) and all non-serious adverse events.
IRR included AEs potentially related to infusion related reaction and was determined by blind medical review prior to the database release.
Participants were monitored from start of study intervention infusion until the end of infusion to assess the infusion sites for erythema, induration, ecchymosis, pain, and pruritus, or other observed characteristics after study intervention.
Laboratory test abnormalities included hematology: basophils/leukocytes greater than (\>)1.2\* upper limit of normal (ULN), eosinophils/leukocytes \>1.2\* ULN, monocytes/leukocytes \>1.2\* ULN; clinical chemistry: bilirubin \> 1.5\* ULN, aspartate aminotransferase \>3.0\* ULN, urate \>1.2\* ULN; urinalysis: ketones greater than or equal to (\>=)1, urine hemoglobin \>=1.
Vital sign abnormalities were categorized as: a) supine systolic blood pressure: minimum: less than (\<) 90 millimeter of mercury (mmHg), maximum decrease from baseline: greater than or equal to (\>=) 30 mmHg, maximum increase from baseline: \>=30 mmHg; b) supine diastolic blood pressure: minimum: \<50 mmHg, maximum decrease from baseline: \>=20 mmHg, maximum increase from baseline: \>=20 mmHg; c) supine pulse rate: minimum \<40 beats per minute (bpm), maximum \>120 bpm. Number of participants with any vital sign abnormality were reported in this outcome measure.
Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec); maximum increase in PR interval from baseline \>=25 percent (%) for baseline value of \>200 msec; maximum increase in PR interval from baseline \>=50% for baseline value of less than or equal to (\<=) 200 msec; maximum QRS interval \>=140 msec and maximum increase from baseline \>=50%; QT interval of \>=500 msec; QTcF interval (Fridericia's Correction of QTc interval) mild: \>=450 msec to \<480 msec, moderate: \>=480 msec to \<500 msec; increase from baseline \>=30 msec to \<60 msec and severe: \>=500 msec; increase from baseline \>=60 msec.
Safety
| Arm | Type | Description |
|---|---|---|
| PF-06823859 | EXPERIMENTAL | Participants will receive PF-06823859 via intravenous infusion every 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo via intravenous infusion every 4 weeks. |
| PF-06823859 low | EXPERIMENTAL | Participants will receive single intravenous infusion. |
| PF-06823859 high | EXPERIMENTAL | Participants will receive single intravenous infusion. |
| Placebo injection SC/IV | PLACEBO_COMPARATOR | Placebo for injection SC/IV |
| Name | Type | Description |
|---|---|---|
| PF-06823859 | DRUG | anti-interferon beta therapy |
| Placebo | DRUG | Placebo for PF-06823859 |
| Placebo injection SC/IV | DRUG | Comparison of Placebo to different doses of PF-06823859 |
Inclusion Criteria: * Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater) * Active dermatomyositis (DM) or polymyositis (PM) with age of onset * 18 years old. * Must be receiving a stable dose of standard of care (SOC) background...
PF-06823859 is an investigational small molecule being studied for the treatment of myositis, specifically active idiopathic inflammatory myopathies including dermatomyositis (DM) and polymyositis (PM). It has also been evaluated in healthy volunteers in earlier-phase trials to assess safety and pharmacokinetics.
PF-06823859 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in patients with myositis.
PF-06823859 is currently in Phase 3 clinical development. A Phase 3 trial (NCT05895786) is recruiting participants with active idiopathic inflammatory myopathies. Earlier Phase 1 studies in healthy volunteers have been completed, and the drug remains investigational and not yet approved by regulatory authorities.
PF-06823859 is being studied in a Phase 3 trial (NCT05895786) for myositis, with an enrollment of 318 participants across multiple countries. Two Phase 1 trials (NCT02766621 and NCT05037409) in healthy volunteers have been completed, evaluating safety, tolerability, pharmacokinetics, and immunogenicity.
PF-06823859 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available data, so it is consistently referred to as PF-06823859 across studies and publications.