A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis

NCT01585233 | Completed Phase 2

• 1 other identifier: 7163-CL-0107
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 13

Brief Summary

The purpose of this study is to explore the safety and tolerability of multiple doses of ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects with moderate to severe psoriasis.

Conditions

Psoriasis

Keywords

Moderate Psoriasis; Severe Psoriasis; Skin disease; ASKP1240; CD40 antigen; Anti-CD40 monoclonal antibody

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 )

  Day 1 to Day 113 (12 visits)

• Pharmacokinetics of ASKP1240: Maximum Concentration (Cmax)

  Day 1 to Day 113 (12 visits)

• Pharmacodynamic variable: CD40 receptor occupancy on peripheral blood B cells

  Day 1 to Day 113 (12 visits)

• Characterize safety profile of ASKP1240 through adverse event reporting, vital signs, clinical laboratory evaluations, physical examinations and 12-lead electrocardiograms (ECGs)

  113 Days

Secondary Outcomes (7)

• Mean change from baseline to 8 weeks in Psoriasis Area Severity Index (PASI) score

  Baseline and 8 weeks

• Mean change from baseline to 8 weeks in Physicians Static Global Assessment (PSGA) score

  Baseline and 8 weeks

• Proportion of Subjects Achieving Treatment Success

  8 weeks

• Mean change from baseline to 8 weeks in % Body Surface Area (BSA)

  Baseline and 8 weeks

• Cytokine Concentration

  Day 1 to Day 113 (9 visits)

Study Arms (5)

Cohort 1

EXPERIMENTAL

ASKP1240 lowest dose

Drug: ASKP1240

Cohort 2

EXPERIMENTAL

ASKP1240 low dose

Drug: ASKP1240

Cohort 3

EXPERIMENTAL

ASKP1240 high dose

Drug: ASKP1240

Cohort 4

EXPERIMENTAL

ASKP1240 highest dose

Drug: ASKP1240

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASKP1240 DRUG

Intravenous

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Intravenous

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a clinical diagnosis of moderate to severe plaque psoriasis for 6 months or longer with at least 5% or greater Body Surface Area (BSA) affected with plaque psoriasis
• Subject must be a candidate for phototherapy and/or systemic therapy
• Subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning booths or other ultraviolet light sources during the study
• Female subject must be either:
• post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
• premenarchal prior to Screening, or
• documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening), or
• if of childbearing potential, must have a negative serum pregnancy test at Screening and if sexually active must be using highly effective contraception. All sexually active subjects will be required to use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• Female subject must not be lactating and must not be breastfeeding at Screening or during the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• Female subject must not donate ova starting at Screening and throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• Male subject and their female spouse/partners who are sexually active must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• Male subject must not donate sperm starting at Screening and throughout the study period and for at least 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• Highly effective contraception is defined as:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)

You may not qualify if:

• Subject has non-plaque psoriasis (such as guttate, erythrodermic or pustular psoriasis)
• Subject has received treatment with systemic, non-biologic psoriasis therapy or other systemic immunosuppressant including investigational use of an approved agent within the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
• Subject has ever been treated with efalizumab (Raptiva®)
• Subject has a total B lymphocyte count by flow cytometric determination that is less than the lower limit of normal
• Subject has a hemoglobin, that are below the lower limit
• Subject has a total white count, total lymphocyte count, total neutrophil count or total platelet that are below the lower limit
• Subject has any of the following lab values:
• ALT ≥ 1.5 x upper limit of normal
• AST ≥ 1.5 x upper limit of normal
• Total bilirubin ≥ 1.5 x upper limit of normal
• Subject has previously received ASKP1240 or has participated in a study involving ASKP1240
• Subject has \> 45 body mass index (BMI)
• Subject with a positive Tubercle Bacillus (TB) test who has not previously received adequate antimicrobial therapy for TB or is currently on, or is planned to start TB antimicrobial therapy
• Subject has abnormal chest x-ray indicative of acute or chronic lung disease
• Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (13)

Specialist Connect

Brisbane, Queensland, 4102, Australia

Location

CMAX

Adelaide, Victoria, 5000, Australia

Location

Epworth Hospital

Richmond, Victoria, 3121, Australia

Location

Linear Research

Nedlands, Western Australia, 6009, Australia

Location

Durondel C.P. Inc, The Dermatology Clinic

Moncton, New Brunswick, E1C 8X3, Canada

Location

New Lab Clinical Research

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

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research, Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Auckland Clinical Studies

Auckland, 1010, New Zealand

Location

Christchurch Clincial Studies Trust, Ltd.

Christchurch, 8011, New Zealand

Location

P3 Research, Tauranga

Tauranga, 3110, New Zealand

Location

P3 Research, Wellington

Wellington, 6021, New Zealand

Location

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

bleselumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: April 30, 2012
• Primary Completion: June 30, 2014
• Study Completion: January 7, 2015
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); NZ (4); AU (4)