Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for dermatomyositis, an inflammatory muscle disease. It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied in patients aged 18 years and older.
Anti-Beta Interferon is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for dermatomyositis.
Anti-Beta Interferon is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is being studied for the treatment of dermatomyositis.
Anti-Beta Interferon has one completed clinical trial, NCT05192200, which was a Phase 2 extension study for participants who completed the treatment period of a qualifying parent study. The trial enrolled 24 patients with dermatomyositis across the United States, Hungary, Poland, and Spain.
Anti-Beta Interferon is a small molecule drug being developed by Pfizer for dermatomyositis. It is distinct from beta interferon therapies, which are typically recombinant proteins used for conditions like multiple sclerosis. The drug is currently in Phase 2 clinical trials.