Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

NCT01010542 | Terminated Phase 1 Results

• 2 other identifiers: 3226K1-1002B1991002
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not the body will develop an immune reaction (sensitivity) to the drug.

Conditions

Plaque Psoriasis

Keywords

Single dose psoriasis study

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2

  PASI score: combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72(maximal disease),with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs:erythema(E),infiltration(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. Percentage of participants with at least 50 percent(%) improvement in total PASI score at Week 2 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.

  Baseline, Week 2

• Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4

  PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 4 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.

  Baseline, Week 4

• Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6

  PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 6 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.

  Baseline, Week 6

• Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8

  PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 8 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.

  Baseline, Week 8

Other Outcomes (18)

• Target Lesion Score (TLS)

  Pre-treatment (Day -1), Week 2, 4, 6, 8

• Physician Global Assessment (PGA) Score of Psoriasis

  Pre-treatment (Day -1), Week 2, 4, 6, 8

• Number of Participants With Laboratory Abnormalities of Potential Clinical Importance

  Baseline (Day 1) up to Week 16

Study Arms (2)

ILV-095

ACTIVE COMPARATOR

Drug: ILV-095 300 mg in a 4 to 1 ratio

placebo

PLACEBO COMPARATOR

Drug: ILV-095 300 mg in a 4 to 1 ratio

Interventions

ILV-095 300 mg in a 4 to 1 ratio DRUG

Single dose of ILV-095 300 mg

ILV-095

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sexually active men or women must agree to use a medically acceptable form of contraception during the study and continue it for 16 weeks after investigational product administration.
• Negative urine pregnancy test result for all women.
• Body mass index (BMI) \>=18 kg/m2 and body weight \>=50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/(height \[m\]).
• Must meet the following criteria for disease activity, at screening and/or at study entry (subjects who washout from prior therapy may not meet this level of disease activity at screening but must before being entered into the study).
• Must have stable moderate to severe chronic plaque psoriasis covering \>=15% of body surface area and be a candidate for systemic therapy or phototherapy.
• Psoriasis Area Severity Index (PASI) score of \>11.
• Physician Global Assessment (PGA) of psoriasis score \>=3.
• Target lesion score \>=6 based on the physician rating of selected sites for erythema, plaque elevation and scaling, with a minimum of 2 on the plaque elevation score. A-12-point score will be used with a 1-4 scale for each domain. Target lesions should not be on the scalp, axillae, face, or groin.

You may not qualify if:

• Presence or history of any disorder that may prevent the successful completion of the study.
• Evidence of unstable clinically significant disease (eg, unstable cardiovascular, renal, respiratory, or psychiatric disease or any serious disorder that currently requires physician care).
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
• Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
• Presence of guttate, erythrodermic, or pustular psoriasis.
• Active severe infections within 4 weeks before study day 1.
• Systemic malignancy within the past 5 years including melanoma. Treated skin cancer (basal cell carcinoma or squamous cell carcinoma) is excluded.
• Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD screening should be performed according to local standards using the tuberculin skin test (TST). Any result \>5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should not be taken into account when interpreting a TST result. TST must be performed during the screening period unless one has been performed within the previous 3 months and the results are available.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

Miami Research Associates, Inc.

South Miami, Florida, 33143, United States

Location

MRA Clinical Research

South Miami, Florida, 33143, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29651, United States

Location

NewLab Clinical Research Inc

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

Limitations and Caveats

The study was early terminated based on the outcome of interim analysis and not due to any safety reasons.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Study Start: December 1, 2009
• Primary Completion: May 20, 2011
• Study Completion: May 20, 2011
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2)