Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ILV-094 · 4 trials · 3 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 28 competitors
ILV-094 is an investigational small molecule being studied for use in healthy subjects, rheumatoid arthritis, and psoriasis. It has been evaluated in clinical trials for these conditions, though it remains in development and is not approved.
The molecular target of ILV-094 has not been disclosed in available information. Its mechanism of action is not publicly specified, and no target class has been identified for this investigational small molecule.
ILV-094 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has sponsored clinical trials evaluating the drug in healthy subjects and in patients with psoriasis and rheumatoid arthritis.
ILV-094 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not received regulatory approval, and its development status beyond these completed studies has not been specified.
ILV-094 has been studied in four completed clinical trials. These include NCT00434746 and NCT00447681 in healthy subjects, NCT00563524 in psoriasis, and NCT00883896 in rheumatoid arthritis. All trials have been completed, with no active studies currently listed.
No alternative names for ILV-094 have been identified. The drug is referred to solely as ILV-094 in clinical trial records and available information.