PsoriasisPhase 1NCT00563524
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
A Phase 1 study testing ILV-094 in people with Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 24 sites in 4 countries.
Trial summary
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- ILV-094
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 20 Dec 2007to 14 Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women of nonchildbearing potential 18 years or older.
- Physician Area and Severity Index (PASI) greater than 11.
- Physician Global Assessment (PGA) greater than 3.
Who cannot join
- Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
- Live vaccines within 3 months before test article administration or during the study.
- Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
- Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
- Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
- Receipt of systemic psoriasis therapy (eg, oral retinoids, methotrexate, hydroxyurea, cyclosporine, or azathioprine) or systemic corticosteroids within 4 weeks before study day 1.
- Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength [class 6 or 7 topical corticosteroids], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States15 sites
David Stoll, MD
Beverly Hills, California, 90212
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Research Institute
Dallas, Texas, 75246-1613
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635-0909
Duke Clinical Reseach Unit
Durham, North Carolina, 27710
Hudson Dermatology
Evansville, Indiana, 47714
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256
New York University Medical Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Dermatology Research
Santa Monica, California, 90404
Miami Research Associates
South Miami, Florida, 33143
MRA Clinical Research
South Miami, Florida, 33143
Central Dermatology
St Louis, Missouri, 63117
Canada6 sites
Stratical Medical
Edmonton, Alberta, T5K 1X3
University of Alberta, Hospital Site Clinical Sciences Building
Edmonton, Alberta, T6G 2B7
The Northern Alberta Clinical Trials and Research Centre (NACTRC)
Edmonton, Alberta, T6G 2C8
Innovaderm Recherches Inc
Montreal, Quebec, H2K 4L5
Bio Pharma Services Inc
Toronto, Ontario, M9L 3A2
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
South Africa2 sites
FARMOVS Parexel (Pty) Ltd
Bloemfontein, Free State, 9301
Parexel George
George, Western Cape, 6529
About this study
Official title: AN ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY OR INTRAVENOUSLY TO SUBJECTS WITH PSORIASIS
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
- Conditions
- Psoriasis
- Being tested
- ILV-094
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILV-094Drug
Also called placebo
SC and IV administration on days 1, 14, 28, and 42
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: ILV-094 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
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.
Measured: Day 1 up to Day 126
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
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.
Measured: Day 1 up to Day 126
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
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.
Measured: Day 1 up to Day 126
Number of Participants With Laboratory Test Values of Potential Clinical Importance
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.
Measured: Day 1 up to Day 126
Secondary outcomes (20)
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal Half-Life (t1/2) of ILV-094: Single Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
AUC (0-312) = Area under the plasma concentration time-curve from time zero (pre-dose) to 312 hours (0-312) postdose of ILV-094.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Apparent Clearance of ILV-094: Multiple Dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after IV dose (apparent clearance) was influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Apparent Volume of Distribution of ILV-094: Multiple Dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Cavg was the average plasma concentration of drug during the dosing interval.
Measured: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Accumulation Ratio (Rac) of ILV-094
Rac was estimated as: X*AUClast of Day 1 divided by AUC312 of Day 42, where X is the ratio of the maintenance dose to the loading dose of ILV-094, AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration and AUC-312 is the AUC from time 0 to 312 hours on Day 42.
Measured: Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Serum C-Reactive Protein (CRP) Levels
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Day 1, 14, 28, 42, 56
Serum Interleukin-6 (IL-6) Levels
Measured: Day 1, 14, 28, 42, 56
Serum Amyloid-A Levels
Measured: Day 1, 14, 28, 42, 56
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
PASI score is the combined assessment of lesion severity and area affected into single score range on a scale of 0 (no disease) to 72 (maximal disease), with higher scores indicating greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
Measured: Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
TLS was based on the severity of 3 components: erythema, induration, and scaling. Severity of each component was evaluated on a 5-point scale as: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with higher scores reflected increased lesion severity. Scores of 3 components were summed to derive the total target lesion score, ranging from 0=none to 12=very marked, with higher scores reflected increased lesion severity.
Measured: Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 = no disease activity to 10 = extreme disease activity, where higher scores indicating greater disease activity.
Measured: Baseline, Week 2, 4, 6, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study start20 Dec 2007
- Primary completion14 Jun 2010
- Study completion14 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563524
- Sponsor's protocol ID
- 3199K2-1105
- Other IDs
- B1981002, 2009-012554-20, 2009
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2007
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY OR INTRAVENOUSLY TO SUBJECTS WITH PSORIASIS
- ClinicalTrials.gov ID
- NCT00563524
- Acronym / sponsor ID
- 3199K2-1105
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2007 (actual)
- Primary completion
- 14 Jun 2010 (actual)
- Study completion
- 14 Jun 2010 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: ILV-094 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women of nonchildbearing potential 18 years or older.
- Physician Area and Severity Index (PASI) greater than 11.
- Physician Global Assessment (PGA) greater than 3.
Key exclusion criteria (7 listed)
- Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
- Live vaccines within 3 months before test article administration or during the study.
- Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
- Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
- Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILV-094Also: placeboSC and IV administration on days 1, 14, 28, and 42 | Drug | 1 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
20 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal Half-Life (t1/2) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Apparent Clearance of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Apparent Volume of Distribution of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Accumulation Ratio (Rac) of ILV-094
Time frame: Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Serum C-Reactive Protein (CRP) Levels
Time frame: Day 1, 14, 28, 42, 56
Serum Interleukin-6 (IL-6) Levels
Time frame: Day 1, 14, 28, 42, 56
Serum Amyloid-A Levels
Time frame: Day 1, 14, 28, 42, 56
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
Time frame: Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
Time frame: Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
Time frame: Baseline, Week 2, 4, 6, 8, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ILV-094 in people with Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, South Africa, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (time frame: Day 1 up to Day 126). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.