Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ILV-094 · 2 trials · 2 indications
ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 126), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both SAEs and all non-SAEs.
Clinically significant ECG findings included: heart rate (HR): less than or equal to (\<=) 45 beats per minute (bpm) or greater than or equal to (\>=)120 bpm or decrease/increase of \>=15 bpm from baseline value, PR interval: \>=220 millisecond (msec) and change of \>=20 msec from baseline value and; QRS interval \>=120 msec; corrected QT (QTc) interval for men greater than (\>) 450 msec, QTc interval for women \>470 msec.
Criteria for identifying vital sign values of PCI: heart rate: increase of \>15 bpm from baseline value and \>=120 bpm and decrease of \>15 bpm from baseline value and \<=45 bpm; Sitting and Supine systolic blood pressure (SBP): increase of \>=20 millimeters of mercury (mm Hg) from baseline value and \>=160 mm Hg and decrease of \>=20 mm Hg from baseline value and \<=90 mm Hg; Sitting and Supine diastolic blood pressure (DBP): increase of \>=15 mm Hg from baseline value and \>=100 mm Hg and decrease of \>=15 mm Hg from baseline value and \<=50 mm Hg; Respiratory rate: \<10 or \>25 breaths/minute; Weight: \>=7 percent increase or decrease from baseline value; Oral temperature: \<35 degree Celsius (C) or \>38.3 degree C.
Criteria:Hematocrit:5% decrease from baseline,Hemoglobin:decrease of \>=20 gram per liter(g/L) from baseline,WBC: \<3.0\*10\^9/L;neutrophils: \<1.5\*10\^9/L,platelet count:\<100\*10\^9/L,eosinophils: \>0.5\*10\^9/L;prothrombin time,partial thromboplastin time: \>1.5\*Upper limit of normal(ULN);sodium,potassium: \>5millimoles per liter(mmol/L)aboveULN/below lower limit of normal(LLN),creatinine: \>1.36\*ULN,urea: \>1.5\*ULN,glucose(fasting): \>0.83mmol/L above ULN/below ULN,glucose (non-fasting): \>5.0 mmol/L above ULN/\>0.56 mmol/L below LLN,calcium:change of \>=0.25 mmol/L from baseline,magnesium:change at \>=0.21mmol/L from baseline value,phosphorus:\>0.162 mmol/L above ULN/below LLN,total protein:change of \>=20 g/L from baseline,albumin:change of \>=10 g/L from baseline,uric acid:change of \>0.119mmol/L from baseline,creatine kinase: \>3\*ULN,cholesterol: \>7.77mmol/L,triglycerides:\>3.39mmol/L;ALT,AST,total bilirubin: \>2\*ULN,alkaline phosphatase: \>1.5\*ULN,Gamma-glutamyl transferase,lactate dehydrogenase: \>3\*ULN.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Part 1: Placebo |
| Arm 2 | EXPERIMENTAL | Part 1: 100 mg ILV-094 SC Q4W |
| Arm 3 | EXPERIMENTAL | Part 1: 100 mg ILV-094 SC Q2W |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Arm 5 | EXPERIMENTAL | Part 2: 200 mg ILV-094 SC Q2W |
| 1 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Part 1: Placebo SC administration every 2 weeks X 10 weeks. |
| ILV-094 | DRUG | Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks. |
Inclusion Criteria: * Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count...
Top 20 of 31 competitors
ILV-094 is an investigational small molecule being studied for the treatment of autoimmune and inflammatory conditions, specifically psoriasis and rheumatoid arthritis. It is not approved for any indication and remains in clinical development. The drug was evaluated in placebo-controlled trials to assess its safety and efficacy in adults with these conditions.
ILV-094 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the clinical trials evaluating ILV-094 in rheumatoid arthritis and psoriasis. The drug is an investigational asset within Pfizer's immunology and inflammation pipeline.
ILV-094 is in Phase 1 development for psoriasis and has also been studied in a Phase 2 trial for rheumatoid arthritis. The Phase 1 psoriasis trial and the Phase 2 rheumatoid arthritis trial have both been completed. The drug is investigational and has not been approved by the FDA for any indication.
ILV-094 has been evaluated in two completed clinical trials. NCT00883896 was a Phase 2 study of ILV-094 in 195 subjects with rheumatoid arthritis, conducted across multiple countries including the United States, Belgium, Colombia, Croatia, Germany, Hungary, Japan, Mexico, the Netherlands, Romania, and Russia. NCT00563524 was a Phase 1 study in 76 subjects with psoriasis.
No, ILV-094 is not FDA approved. It is an investigational small molecule in clinical development. The completed trials include a Phase 1 study in psoriasis and a Phase 2 study in rheumatoid arthritis. Approval status has not been granted for any indication.