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Also known as Anti-Beta Interferon (PF-06823859)
Anti-Beta Interferon · 1 trial · 1 indication
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Anti-Beta Interferon drug (PF-06823859) | EXPERIMENTAL | IV infusion |
| Name | Type | Description |
|---|---|---|
| Anti-Beta Interferon (PF-06823859) | DRUG | IV infusion |
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,...
Anti-beta interferon is being developed for dermatomyositis, an inflammatory muscle disease. It is an investigational therapy that has been studied in a Phase 2 clinical trial in adults with this condition. It has not been approved for any use.
Anti-beta interferon is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program studying this asset in dermatomyositis.
Anti-beta interferon is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA for dermatomyositis or any other indication.
Anti-beta interferon has been studied in one Phase 2 trial, NCT05192200, an extension study for participants who completed the treatment period of a qualifying parent study. The trial enrolled 24 adults with dermatomyositis across the United States, Hungary, Poland, and Spain, and it is now completed.
Yes. Anti-beta interferon is also known as PF-06823859, which is Pfizer's internal development code for the same investigational asset. Both names refer to the same molecule being studied in dermatomyositis.
The completed Phase 2 trial of anti-beta interferon, NCT05192200, enrolled 24 participants. It was an uncontrolled extension study without randomization or double blinding, and it enrolled adults aged 18 years and older with dermatomyositis.