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ILV-094

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Aug 23, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

Clinical trial landscape

ILV-094 · 4 trials · 3 indications

Phase 2 1Phase 1 3
NCT00883896Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED195 Analytics
PHASE2COMPLETED
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
Week 12

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).

Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Day 1 up to Day 126

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.

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Day 1 up to Day 126

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.

Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
Day 1 up to Day 126

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.

Number of Participants With Laboratory Test Values of Potential Clinical Importance
Day 1 up to Day 126

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.

To provide safety, tolerability, PK and immunogenicity profiles
1 year
To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

Secondary Endpoints

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10
Week 2, 4, 6, 8, 10
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12
Week 2, 4, 6, 8, 10, 12
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12
Week 2, 4, 6, 8, 10, 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1PLACEBO_COMPARATORPart 1: Placebo
Arm 2EXPERIMENTALPart 1: 100 mg ILV-094 SC Q4W
Arm 3EXPERIMENTALPart 1: 100 mg ILV-094 SC Q2W
Arm 4PLACEBO_COMPARATOR -
Arm 5EXPERIMENTALPart 2: 200 mg ILV-094 SC Q2W
1PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboOTHERPart 1: Placebo SC administration every 2 weeks X 10 weeks.
ILV-094DRUGPart 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

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...

Countries:United StatesBelgiumColombiaCroatiaGermanyHungaryJapanMexicoNetherlandsRomaniaRussiaCanadaHong KongSouth Africa
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Frequently asked questions about ILV-094

What is ILV-094 used for?

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.

What does ILV-094 target?

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.

Who makes ILV-094?

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.

What phase is ILV-094 in?

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.

What clinical trials is ILV-094 in?

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.

Is ILV-094 the same as another drug?

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.